Purity and Potency

Valerian, an herbal product, is also available without a prescription. The recommended dose is 300 to 600 mg. Purity and potency concerns are an issue. It may cause daytime sedation. 

Stability testing is another quantitative test that is routinely used in TLC. A drug substance or drug product is placed on stability and pulled at an appropriate time point. These samples are examined for visual changes as well as purity and potency changes. TLC testing can be done... 

The Insulin Amendment requires FDA to test and certify the purity and potency of insulin. 

The FDA s dehnition of comparability protocol is a well-defined, written plan for assessing the effect of specific CMC changes in the identity, strength, purity, and potency of a specific drug product as these factors relate to the safety and effectiveness of the product. A comparability protocol describes changes that are covered under the protocol and specifies the tests and studies that will be performed, including analytical procedures that will be used, and acceptance criteria that will be achieved to demonstrate that specified CMC changes do not adversely affect the product. ... 

Test a sample of the product s properties and characteristics (melting point, boiling point, weight). Cocaine and most of the other drugs will have specific tests that should be performed also to determine purity and potency. 

A comparability protocol is a well-defined, detailed, written plan for assessing the effect of specific CMC changes in the identity, strength, quality, purity, and potency of a specific drug product as these factors relate to the safety and effectiveness of the product. 

Analytical methods used to determine purity and potency of an experimental API that is very early in development will need a less rigorous method validation exercise than would be required for a quality control laboratory method at the manufacturing site. An early phase project may have only a limited number of lots to be tested and the testing may be performed in only one laboratory by a limited number of analysts. The ability of the laboratory to control the method and its use is relatively high, particularly if laboratory leadership is clear in its expectations for the performance of the work. 

Tightening of acceptance criteria for existing reference standards to provide greater assurance of product purity and potency. 

Purity and potency are two of the metrics that pharmaceutical quality assurance (QA) departments emphasize to determine if a batch may be released. To do this they typically employ HPLC and/or mass spectrometry to determine gross composition, and to verify the absence of any contaminants. However, only a small subset of tablets in a batch is tested because the tests destroy the sample. While these methods offer some insight into sample consistency, they provide no information on the distribution of the components in an individual finished form. Dissolution testing is used to indicate the manner and... 

N. A. Farid, L. M. Atkins, G. W. Becker, A. Dinner, R. E. Heiney, and D. J. Miner, Liquid chromatographic control of the identity, purity and potency of biomolecules used as drugs, J. Pharm. Biomed Anal., 7 185(1989)... 

As with small molecules, the key analytical parameters to be addressed for therapeutic proteins on a lot-to-lot basis are identity, purity, and potency. In addition, a rigorous proof of structure is required for the reference standard lot to be used for routine analysis of production batches. 

Three main situations can distinguished. The first is the preparation of antibodies for diagnostic use in vitro, the second is related to the therapeutic use for relatively modest amounts of antibodies, and the third addresses very large amounts of antibodies for both therapeutic and prophylactic applications. In the second and third situations, although antibodies would meet similar requirements of safety, purity, and potency, the issue of market must be addressed. The production cost resulting from both the method of expression and the purification process must be considered. 

Not until 1944, when Congress modified the statute, did federal law require the licensure of products as well. Under the revision, both establishments and products must meet standards designed to insure the continued safety, purity, and potency of such products, prescribed in regulation. ... 

Insulin Amendment passed to require FDA testing/certification of purity and potency. 

Eszopiclone has a rapid onset and a duration of action of up to 6 hours. The most common adverse effects are somnolence, unpleasant taste, headache, and dry mouth. It may be taken nightly for up to 6 months. Valerian, an herbal product, is also available without a prescription. The recommended dose is 300 to 600 mg. Purity and potency concerns are an issue. It may cause daytime sedation. 

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