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Back to Search Results. CONNECT WITH US Contact Us Media Portfolio. All Rights Reserved. For example, acetaminophen—the active ingredient in Tylenol—is a well-known API. This can help you better communicate with your healthcare providers, recognize which generics and brand name versions are the same, and avoid harmful interactions and accidental overdoses.

This article discusses APIs, what they are, why they're important, and how to find them on a drug label. Drugs are manufactured under stringent conditions to maintain consistency and minimize the risk of contamination.

All drugs are made up of two core components:. Excipients are chemically inactive substances such as binders, preservatives, and artificial dyes that give the pill its color. Some of these materials are used to help the medication remain stable and to control absorption when you take the drug.

Excipients like gluten, lactose, sugar, and some dyes can cause allergic reactions in some people. The Food and Drug Administration FDA requires equivalency testing for generic drugs to ensure that they are of the same potency as the brand versions.

Some generic drugs may contain different excipients than the brand versions, but many generics are identical to them. Some common OTC and prescription medications and their active pharmaceutical ingredients include:. There are many situations when you will benefit from knowing the APIs of medications you are taking.

Here are a few examples:. You could end up taking too much of any of these APIs if you aren't aware that they are available In different medications and brands. Furthermore, if a medication that you're taking isn't working or is causing side effects, then you can avoid jumping to the same API by a different name in a potentially futile attempt to try something that you think is different.

For OTC drugs, the API and the amount each dose contains are listed at the top of the Drug Facts label under the heading "Active Ingredient.

Prescription drug labels list the brand name of the drug if applicable above the generic name. The generic name is also the API of that drug.

If you received the generic version of the drug, the label may also tell you what brand name the drug is usually sold under. For example: "Amphetamine 10MG: Generic for Adderall 10MG. The generic name of a drug is typically a derivative of the chemical name, which is used less often.

For example, the chemical name for aspirin is acetylsalicylic acid. Other than the U. Chart 1. Strategy to assess quality consistency of a drug product. a The procedure to identify groups. b The procedure to reduce the data dimensions. c The procedure to assess quality consistency using the index of quality consistency attribute QCA.

d The recognition rate of changes RRC is the matching rate between cluster results given by cluster analysis and real groups identified by the production conditions. RRC max was the highest RRC of possible CQAs in a production process. e The process consistency attribute PrCA is the discriminant value calculated by multiple linear regression, another index to assess quality consistency.

Meanwhile, through this strategy as shown in Chart 1 , it is possible to improve the quality standard of a specific drug, as well as achieve a timely and targeted process feedback survey; these were helpful in the control of product quality and to the production attributes required for real-time release.

The datasets generated for this study are available on request to the corresponding author. SQ: design of experiments, data acquisition, analysis of data.

SY: assisted analysis of attributes in quality standard. LY: assisted analysis of process attributes. CH: design of experiments, analysis of data. This work was supported by the National Major Scientific and Technological Special Project for Significant New Drugs Development [grant number ZX].

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Bartholomew, D. Analysis of Multivariate Social Science Data. Statistics in the Social and Behavioral Sciences Series. Google Scholar. Bökeoglu Cokluk, Ö. Discriminant function analysis: Concept and application. Egitim Arastirmalari Eurasian J.

Everitt, B. An Introduction to Applied Multivariate Analysis with R. New York, NY: Springer. Hedegaard, M. Spectral unmixing and clustering algorithms for assessment of single cells by raman microscopic imaging.

doi: CrossRef Full Text Google Scholar. Howell, D. Statistical Methods for Psychology. Belmont, CA: Duxbury Press. International Conference on Harmonisation Quality Risk Management Q 9.

PubMed Abstract. International Conference on Harmonisation. Pharmaceutical Development Q 8 R2. Jolliffe, I. Principal component analysis, Series: Springer Series in Statistics , 2nd edn, New York, NY: Springer. ISBN Montgomery, D. Design and Analysis of Experiments. New York, NY: Wiley. Parenteral Drug Association.

Technical Report No. Qi, S. Characterization of solid-state drug polymorphs and real-time evaluation of crystallization process consistency by near-infrared spectroscopy.

PubMed Abstract CrossRef Full Text Google Scholar. Keywords: quality consistency, critical quality attribute, quality standard, process variation, assessment strategy, drug product. Citation: Qi SY, Yao SC, Yin LH and Hu CQ A Strategy to Assess Quality Consistency of Drug Products.

Received: 14 December ; Accepted: 05 March ; Published: 26 March Copyright © Qi, Yao, Yin and Hu. This is an open-access article distributed under the terms of the Creative Commons Attribution License CC BY.

The use, distribution or reproduction in other forums is permitted, provided the original author s and the copyright owner s are credited and that the original publication in this journal is cited, in accordance with accepted academic practice.

No use, distribution or reproduction is permitted which does not comply with these terms. Hu, hucq nifdc. Export citation EndNote Reference Manager Simple TEXT file BibTex. Check for updates. ORIGINAL RESEARCH article.

A Strategy to Assess Quality Consistency of Drug Products Shu Y. Qi 1,2 Shang C. Yao 1 Li H. Yin 1 Chang Q. Introduction The quality of a drug medicinal product should be strictly controlled to ensure its safety and efficacy; this serves as a basis for formulating quality standards.

Materials and Methods Samples The samples of α-CEZ-Na from three processing periods Period 1: July — January and September ; Period 2: November —December ; Period 3: January —March were provided by Shenzhen Gosun Pharmaceutical Co. NIR Samples were directly scanned in vials using a Fourier transform NIR integrating sphere MPA, Bruker, Switzerland.

The cleaning validation protocol should describe the equipment to be cleaned, procedures, materials, acceptable cleaning levels, parameters to be monitored and controlled, and analytical methods. The protocol should also indicate the type of samples to be obtained and how they are collected and labeled.

Sampling should include swabbing, rinsing, or alternative methods e. The sampling methods used should be capable of quantitatively measuring levels of residues remaining on the equipment surfaces after cleaning. Validated analytical methods having sensitivity to detect residues or contaminants should be used.

The detection limit for each analytical method should be sufficiently sensitive to detect the established acceptable level of the residue or contaminant.

The method's attainable recovery level should be established. Residue limits should be practical, achievable, verifiable, and based on the most deleterious residue.

Limits can be established based on the minimum known pharmacological, toxicological, or physiological activity of the API or its most deleterious component. Cleaning procedures should be monitored at appropriate intervals after validation to ensure that these procedures are effective when used during routine production.

Equipment cleanliness can be monitored by analytical testing and visual examination, where feasible. Validation of Analytical Methods Analytical methods should be validated unless the method employed is included in the relevant pharmacopoeia or other recognized standard reference.

The suitability of all testing methods used should nonetheless be verified under actual conditions of use and documented. Methods should be validated to include consideration of characteristics included within the ICH guidances on validation of analytical methods. The degree of analytical validation performed should reflect the purpose of the analysis and the stage of the API production process.

Appropriate qualification of analytical equipment should be considered before initiating validation of analytical methods.

Complete records should be maintained of any modification of a validated analytical method. Such records should include the reason for the modification and appropriate data to verify that the modification produces results that are as accurate and reliable as the established method.

A formal change control system should be established to evaluate all changes that could affect the production and control of the intermediate or API. Written procedures should provide for the identification, documentation, appropriate review, and approval of changes in raw materials, specifications, analytical methods, facilities, support systems, equipment including computer hardware , processing steps, labeling and packaging materials, and computer software.

Any proposals for GMP relevant changes should be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality unit s. The potential impact of the proposed change on the quality of the intermediate or API should be evaluated.

A classification procedure may help in determining the level of testing, validation, and documentation needed to justify changes to a validated process. Changes can be classified e. Scientific judgment should determine what additional testing and validation studies are appropriate to justify a change in a validated process.

When implementing approved changes, measures should be taken to ensure that all documents affected by the changes are revised. After the change has been implemented, there should be an evaluation of the first batches produced or tested under the change.

The potential for critical changes to affect established retest or expiry dates should be evaluated. Current dosage form manufacturers should be notified of changes from established production and process control procedures that can affect the quality of the API.

REJECTION AND RE-USE OF MATERIALS Intermediates and APIs failing to meet established specifications should be identified as such and quarantined. These intermediates or APIs can be reprocessed or reworked as described below. The final disposition of rejected materials should be recorded.

Introducing an intermediate or API, including one that does not conform to standards or specifications, back into the process and reprocessing by repeating a crystallization step or other appropriate chemical or physical manipulation steps e. However, if such reprocessing is used for a majority of batches, such reprocessing should be included as part of the standard manufacturing process.

Continuation of a process step after an in-process control test has shown that the step is incomplete is considered to be part of the normal process. This is not considered to be reprocessing. Introducing unreacted material back into a process and repeating a chemical reaction is considered to be reprocessing unless it is part of the established process.

Such reprocessing should be preceded by careful evaluation to ensure that the quality of the intermediate or API is not adversely affected due to the potential formation of by-products and over-reacted materials. Before a decision is taken to rework batches that do not conform to established standards or specifications, an investigation into the reason for nonconformance should be performed.

Batches that have been reworked should be subjected to appropriate evaluation, testing, stability testing if warranted, and documentation to show that the reworked product is of equivalent quality to that produced by the original process.

Concurrent validation is often the appropriate validation approach for rework procedures. This allows a protocol to define the rework procedure, how it will be carried out, and the expected results.

If there is only one batch to be reworked, a report can be written and the batch released once it is found to be acceptable.

Procedures should provide for comparing the impurity profile of each reworked batch against batches manufactured by the established process. Where routine analytical methods are inadequate to characterize the reworked batch, additional methods should be used. Recovery of Materials and Solvents Recovery e.

Solvents can be recovered and reused in the same processes or in different processes, provided that the recovery procedures are controlled and monitored to ensure that solvents meet appropriate standards before reuse or commingling with other approved materials.

Fresh and recovered solvents and reagents can be combined if adequate testing has shown their suitability for all manufacturing processes in which they may be used.

The use of recovered solvents, mother liquors, and other recovered materials should be adequately documented.

If the conditions under which returned intermediates or APIs have been stored or shipped before or during their return or the condition of their containers casts doubt on their quality, the returned intermediates or APIs should be reprocessed, reworked, or destroyed, as appropriate.

Records of returned intermediates or APIs should be maintained. For each return, documentation should include:. All quality-related complaints, whether received orally or in writing, should be recorded and investigated according to a written procedure.

Records of complaints should be retained to evaluate trends, product-related frequencies, and severity with a view to taking additional, and if appropriate, immediate corrective action. There should be a written procedure that defines the circumstances under which a recall of an intermediate or API should be considered.

The recall procedure should designate who should be involved in evaluating the information, how a recall should be initiated, who should be informed about the recall, and how the recalled material should be treated.

All contract manufacturers including laboratories should comply with the GMP defined in this guidance. Special consideration should be given to the prevention of cross-contamination and to maintaining traceability.

Companies should evaluate any contractors including laboratories to ensure GMP compliance of the specific operations occurring at the contractor sites. There should be a written and approved contract or formal agreement between a company and its contractors that defines in detail the GMP responsibilities, including the quality measures, of each party.

Where subcontracting is allowed, a contractor should not pass to a third party any of the work entrusted to it under the contract without the company's prior evaluation and approval of the arrangements.

Manufacturing and laboratory records should be kept at the site where the activity occurs and be readily available. Changes in the process, equipment, test methods, specifications, or other contractual requirements should not be made unless the contract giver is informed and approves the changes.

All agents, brokers, traders, distributors, repackers, and relabelers should comply with GMP as defined in this guidance. Traceability of Distributed APIs and Intermediates Agents, brokers, traders, distributors, repackers, or relabelers should maintain complete traceability of APIs and intermediates that they distribute.

Documents that should be retained and available include:. Agents, brokers, traders, distributors, repackers, or relabelers should establish, document and implement an effective system of managing quality, as specified in Section 2.

Repackaging, Relabeling, and Holding of APIs and Intermediates Repackaging, relabeling, and holding APIs and intermediates should be performed under appropriate GMP controls, as stipulated in this guidance, to avoid mix-ups and loss of API or intermediate identity or purity.

Repackaging should be conducted under appropriate environmental conditions to avoid contamination and cross-contamination.

Stability studies to justify assigned expiration or retest dates should be conducted if the API or intermediate is repackaged in a different type of container than that used by the API or intermediate manufacturer.

Agents, brokers, distributors, repackers, or relabelers should transfer all quality or regulatory information received from an API or intermediate manufacturer to the customer, and from the customer to the API or intermediate manufacturer.

The agent, broker, trader, distributor, repacker, or relabeler who supplies the API or intermediate to the customer should provide the name of the original API or intermediate manufacturer and the batch number s supplied. The agent should also provide the identity of the original API or intermediate manufacturer to regulatory authorities upon request.

The original manufacturer can respond to the regulatory authority directly or through its authorized agents, depending on the legal relationship between the authorized agents and the original API or intermediate manufacturer.

In this context authorized refers to authorized by the manufacturer. Handling of Complaints and Recalls Agents, brokers, traders, distributors, repackers, or relabelers should maintain records of complaints and recalls, as specified in Section 15, for all complaints and recalls that come to their attention.

If the situation warrants, the agents, brokers, traders, distributors, repackers, or relabelers should review the complaint with the original API or intermediate manufacturer to determine whether any further action, either with other customers who may have received this API or intermediate or with the regulatory authority, or both, should be initiated.

The investigation into the cause for the complaint or recall should be conducted and documented by the appropriate party. Where a complaint is referred to the original API or intermediate manufacturer, the record maintained by the agents, brokers, traders, distributors, repackers, or relabelers should include any response received from the original API or intermediate manufacturer including date and information provided.

Returns should be handled as specified in Section The agents, brokers, traders, distributors, repackers, or relabelers should maintain documentation of returned APIs and intermediates. Section 18 is intended to address specific controls for APIs or intermediates manufactured by cell culture or fermentation using natural or recombinant organisms and that have not been covered adequately in the previous sections.

It is not intended to be a stand-alone section. In general, the GMP principles in the other sections of this document apply. Where practical, this section will address these differences. In general, the degree of control for biotechnological processes used to produce proteins and polypeptides is greater than that for classical fermentation processes.

The term biotechnological process biotech refers to the use of cells or organisms that have been generated or modified by recombinant DNA, hybridoma, or other technology to produce APIs. The APIs produced by biotechnological processes normally consist of high molecular weight substances, such as proteins and polypeptides, for which specific guidance is given in this Section.

Certain APIs of low molecular weight, such as antibiotics, amino acids, vitamins, and carbohydrates, can also be produced by recombinant DNA technology. The level of control for these types of APIs is similar to that employed for classical fermentation. APIs produced by classical fermentation are normally low molecular weight products such as antibiotics, amino acids, vitamins, and carbohydrates.

Production of APIs or intermediates from cell culture or fermentation involves biological processes such as cultivation of cells or extraction and purification of material from living organisms. Note that there may be additional process steps, such as physicochemical modification, that are part of the manufacturing process.

The raw materials used media, buffer components may provide the potential for growth of microbiological contaminants. Appropriate equipment and environmental controls should be used to minimize the risk of contamination. The acceptance criteria for determining environmental quality and the frequency of monitoring should depend on the step in production and the production conditions open, closed, or contained systems.

Where appropriate, the removal of media components, host cell proteins, other process-related impurities, product-related impurities and contaminants should be demonstrated. Cell Bank Maintenance and Record Keeping Cell banks should be maintained under storage conditions designed to maintain viability and prevent contamination.

Where cell substrates, media, buffers, and gases are to be added under aseptic conditions, closed or contained systems should be used where possible. If the inoculation of the initial vessel or subsequent transfers or additions media, buffers are performed in open vessels, there should be controls and procedures in place to minimize the risk of contamination.

Where the quality of the API can be affected by microbial contamination, manipulations using open vessels should be performed in a biosafety cabinet or similarly controlled environment. Critical operating parameters for example temperature, pH, agitation rates, addition of gases, pressure should be monitored to ensure consistency with the established process.

Cell growth, viability for most cell culture processes , and, where appropriate, productivity should also be monitored. Critical parameters will vary from one process to another, and for classical fermentation, certain parameters cell viability, for example may not need to be monitored.

Cell culture equipment should be cleaned and sterilized after use. As appropriate, fermentation equipment should be cleaned, sanitized, or sterilized. Culture media should be sterilized before use, when necessary, to protect the quality of the API. Appropriate procedures should be in place to detect contamination and determine the course of action to be taken.

Procedures should be available to determine the impact of the contamination on the product and to decontaminate the equipment and return it to a condition to be used in subsequent batches. Foreign organisms observed during fermentation processes should be identified, as appropriate, and the effect of their presence on product quality should be assessed, if necessary.

The results of such assessments should be taken into consideration in the disposition of the material produced. Shared multi-product equipment may warrant additional testing after cleaning between product campaigns, as appropriate, to minimize the risk of cross-contamination.

Harvesting, Isolation and Purification Harvesting steps, either to remove cells or cellular components or to collect cellular components after disruption should be performed in equipment and areas designed to minimize the risk of contamination. Harvest and purification procedures that remove or inactivate the producing organism, cellular debris and media components while minimizing degradation, contamination, and loss of quality should be adequate to ensure that the intermediate or API is recovered with consistent quality.

All equipment should be properly cleaned and, as appropriate, sanitized after use. Multiple successive batching without cleaning can be used if intermediate or API quality is not compromised.

If open systems are used, purification should be performed under environmental conditions appropriate for the preservation of product quality. Additional controls, such as the use of dedicated chromatography resins or additional testing, may be appropriate if equipment is to be used for multiple products.

See ICH guidance Q5A Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin for more specific information. Viral removal and viral inactivation steps are critical processing steps for some processes and should be performed within their validated parameters.

Therefore, open processing should be performed in areas that are separate from other processing activities and have separate air handling units. The same equipment is not normally used for different purification steps. However, if the same equipment is to be used, the equipment should be appropriately cleaned and sanitized before reuse.

Appropriate precautions should be taken to prevent potential virus carry-over e. APIs FOR USE IN CLINICAL TRIALS Not all the controls in the previous sections of this guidance are appropriate for the manufacture of a new API for investigational use during its development.

Section XIX 19 provides specific guidance unique to these circumstances. The controls used in the manufacture of APIs for use in clinical trials should be consistent with the stage of development of the drug product incorporating the API.

Process and test procedures should be flexible to provide for changes as knowledge of the process increases and clinical testing of a drug product progresses from pre-clinical stages through clinical stages.

Once drug development reaches the stage where the API is produced for use in drug products intended for clinical trials, manufacturers should ensure that APIs are manufactured in suitable facilities using appropriate production and control procedures to ensure the quality of the API.

Appropriate GMP concepts should be applied in the production of APIs for use in clinical trials with a suitable mechanism for approval of each batch. A quality unit s independent from production should be established for the approval or rejection of each batch of API for use in clinical trials.

Some of the testing functions commonly performed by the quality unit s can be performed within other organizational units. Quality measures should include a system for testing of raw materials, packaging materials, intermediates, and APIs. Labeling for APIs intended for use in clinical trials should be appropriately controlled and should identify the material as being for investigational use.

During all phases of clinical development, including the use of small-scale facilities or laboratories to manufacture batches of APIs for use in clinical trials, procedures should be in place to ensure that equipment is calibrated, clean, and suitable for its intended use.

Procedures for the use of facilities should ensure that materials are handled in a manner that minimizes the risk of contamination and cross-contamination. Raw materials used in production of APIs for use in clinical trials should be evaluated by testing, or received with a supplier's analysis and subjected to identity testing.

When a material is considered hazardous, a supplier's analysis should suffice. In some instances, the suitability of a raw material can be determined before use based on acceptability in small-scale reactions i. The production of APIs for use in clinical trials should be documented in laboratory notebooks, batch records, or by other appropriate means.

These documents should include information on the use of production materials, equipment, processing, and scientific observations.

Expected yields can be more variable and less defined than the expected yields used in commercial processes. Investigations into yield variations are not expected. Process validation for the production of APIs for use in clinical trials is normally inappropriate, where a single API batch is produced or where process changes during API development make batch replication difficult or inexact.

The combination of controls, calibration, and, where appropriate, equipment qualification ensures API quality during this development phase. Process validation should be conducted in accordance with Section 12 when batches are produced for commercial use, even when such batches are produced on a pilot or small scale.

Changes are expected during development, as knowledge is gained and the production is scaled up. Every change in the production, specifications, or test procedures should be adequately recorded. While analytical methods performed to evaluate a batch of API for clinical trials may not yet be validated, they should be scientifically sound.

A system for retaining reserve samples of all batches should be in place. This system should ensure that a sufficient quantity of each reserve sample is retained for an appropriate length of time after approval, termination, or discontinuation of an application.

Expiry and retest dating as defined in Section For new APIs, Section A system should be in place to ensure that information gained during the development and the manufacture of APIs for use in clinical trials is documented and available.

The development and implementation of the analytical methods used to support the release of a batch of API for use in clinical trials should be appropriately documented. A system for retaining production and control records and documents should be used.

This system should ensure that records and documents are retained for an appropriate length of time after the approval, termination, or discontinuation of an application.

Acceptance Criteria: Numerical limits, ranges, or other suitable measures for acceptance of test results. Active Pharmaceutical Ingredient API or Drug Substance : Any substance or mixture of substances intended to be used in the manufacture of a drug medicinal product and that, when used in the production of a drug, becomes an active ingredient of the drug product.

Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

API Starting Material: A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. API starting materials are normally of defined chemical properties and structure.

Batch or Lot : A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production.

The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval. Bioburden: The level and type e. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.

Calibration: The demonstration that a particular instrument or device produces results within specified limits by comparison with results produced by a reference or traceable standard over an appropriate range of measurements. Computer System: A group of hardware components and associated software designed and assembled to perform a specific function or group of functions.

Contamination: The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API during production, sampling, packaging, or repackaging, storage or transport.

Contract Manufacturer: A manufacturer who performs some aspect of manufacturing on behalf of the original manufacturer. Critical: Describes a process step, process condition, test requirement, or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the API meets its specification.

Cross-Contamination: Contamination of a material or product with another material or product. Drug Medicinal Product: The dosage form in the final immediate packaging intended for marketing. Reference Q1A. Impurity: Any component present in the intermediate or API that is not the desired entity.

Impurity Profile: A description of the identified and unidentified impurities present in an API. Intermediate: A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API.

Intermediates may or may not be isolated. Note: this guidance only addresses those intermediates produced after the point that a company has defined as the point at which the production of the API begins. Manufacture: All operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage, and distribution of APIs and related controls.

Material: A general term used to denote raw materials starting materials, reagents, solvents , process aids, intermediates, APIs, and packaging and labeling materials. Mother Liquor: The residual liquid that remains after the crystallization or isolation processes.

It can be used for further processing. Packaging Material: Any material intended to protect an intermediate or API during storage and transport. Procedure: A documented description of the operations to be performed, the precautions to be taken, and measures to be applied directly or indirectly related to the manufacture of an intermediate or API.

Process Aids: Materials, excluding solvents, used as an aid in the manufacture of an intermediate or API that do not themselves participate in a chemical or biological reaction e.

Process Control : See In-Process Control. Production: All operations involved in the preparation of an API from receipt of materials through processing and packaging of the API.

Qualification: Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results.

Qualification is part of validation, but the individual qualification steps alone do not constitute process validation. Quality Assurance QA : The sum total of the organized arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained.

Quality Unit s : An organizational unit independent of production that fulfills both quality assurance and quality control responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.

Quarantine: The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.

Raw Material: A general term used to denote starting materials, reagents, and solvents intended for use in the production of intermediates or APIs. Reference Standard, Primary: A substance that has been shown by an extensive set of analytical tests to be authentic material that should be of high purity.

This standard can be: 1 obtained from an officially recognized source, 2 prepared by independent synthesis, 3 obtained from existing production material of high purity, or 4 prepared by further purification of existing production material.

Reference Standard, Secondary: A substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference standard for routine laboratory analysis.

Color consistency in pharmaceutical powders and plaques is essential for developing the right drug formulations and repeating these formulas accurately every time. Although outward appearance and color-coding do have their place in prescription drugs , what consumers and patients are most concerned about is that the active pharmaceutical ingredients will be the precise dosage and formulation they need each time they take a medication.

Spectrophotometers measure color consistency to ensure that each powder or plaque formulation attains precisely the correct components for effectiveness and safety. Color consistency measurements ensure that the correct formulations of powdered ingredients are achieved before the medication is pressed into tablet form.

Image Source: Flickr user Steve Snodgrass. Spectrophotometers use color technology to measure slight variations in pharmaceutical powders and plaques. The determination of color consistency is an important step in the blending process of medications. This data shows the levels of color consistency which can then be used to create repeatability from batch to batch.

This is extremely important when trying to monitor microscopic amounts of API in powder mixtures which are undetectable through human eye analysis.

Blending is a crucial step in the development of pharmaceuticals and color consistency measurements are essential for creating a product where the API is evenly distributed throughout. This is important for maintaining the right dosages of API in the final product.

If errors are made in the blending stages, it can lead to expensive reformulation or recalls further on down the line. Animal derived hydrocolloids: such as gelatin, chitosan and caseinates.

In the pharmaceutical field, the most important vinyl polymers are:. Ethylene-vinyl acetates: Ethylene vinyl acetates EVAs are copolymers of ethylene and vinyl acetate monomers produced by free radical polymerisation under high temperature and pressure. Varying vinyl acetate composition impacts polymer properties such as melting point, crystallinity and polarity, solubility, transparency, hardness and compatibility with active ingredients.

EVAs provide tackiness, bioadhesion and flexibility. Polyvinyl alcohol: Polyvinyl alcohol PVA is a water-soluble and biodegradable polymer obtained by polymerisation of vinyl acetate followed by partial hydrolysis. Clays are fine-grained naturally-occurring aluminium silicates with traces of other inorganic oxides.

They typically consist of plate-like crystal habits. The most well-known clays in the pharmaceutical field are bentonite, hectorite and magnesium aluminium silicate. Owing to their platy habits, aluminium silicate particle planes possess different surface charge characteristics and complex modes of particle-particle interaction, depending on concentration and pH, among other factors.

In suspension, hydrodynamic forces or the influence of electroviscous effects of clay solutions impacts rheology and viscosity of clay suspensions, much the same way as polymers dispersions.

Carbomer are a group of closely related synthetic, high molecular weight, nonlinear polymers of polyacrylic acids, cross-linked with a polyalkenyl polyether. Carbomer are highly versatile and multifunctional excipients for oral solid and liquids and topical formulations.

When hydrated and neutralised, they yield highly viscous gels with viscosities upwards of 40, mPa s for concentrations as low as 0. Carbomers: Overview, key properties and formulating tips. Concentrated solutions of sugars, oligosaccharides and polyols behave very much like high molecular weight polymer solutions owing to increased intermolecular attractions between sugar molecules hydrogen bonds and the solvent.

When sheared, the interactions create a drag which manifests as an increase in viscosity. This class of viscosity-increasing agents include liquid Sorbitol , liquid Maltitol , sucrose, fructose, dextrose, maltodextrin and Polydextrose. Polyethylene glycol and polyethylene oxide : Polyethylene glycol and polyethylene oxide are related non-ionic polymers formed by the reaction of ethylene oxide and water under pressure in the presence of a catalyst.

Low molecular weight polyethylene glycol grades are liquids and used primarily as solvents and co-solvents in oral and topical formulations.

Solid polyethylene glycol grades are used suspending agents or to adjust the viscosity and consistency of other suspending vehicles. Silica : Also known as colloidal silicon dioxide, silica is an oxide of silicon with the chemical formula SiO2.

Silica grades with a high specific surface area are used to thicken polar liquids thereby converting them into transparent gels. This effect can be used as stabilising strategy for emulsions and semisolid preparations. Many pharmaceutical excipients are often added to formulations to increase the viscosity or thicken liquid formulations.

This property can be utilised to improve product properties, including drug delivery, stabilisation, demulcent effects, and texturizing. The range of materials that serve this function is very broad, but typically includes hydrocolloid gums, synthetic polymers, sugars and polyol syrups and many other miscellaneous materials.

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