Drugs stability tests

M. J. Kaufman, Applications of oxygen polarography to drug stability testing and formulation development Solution-phase oxidation of hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, Pharm. Res. 7, 289-292(1990). 

Pharmaceutical Impurities in synthetic drugs Stability tests of synthetic drugs Content uniformity Pharmacokinetic studies and drug monitoring Assay Enantiomeric purity... 

HHS/FDA International Conference on Harmonisation Stability Testing of New Drug Substances and Products Guideline Availability Notice, Federal Register, September 22, 1994... 

GL3 Stability 1 Stability testing of new drug substances and products... 

Drug substance/drug product purity, potency, and other testing Drug substance/drug product stability testing Method development, validation, and transfer Drug product formulation development... 

The purpose of stability testing is to assess the effects of temperature, humidity, light, and other environmental factors on the quality of a drug substance or product. The data produced are used to establish storage conditions, retest periods, shelf loss, and to justify overages included in products for stability reasons. The most useful equation relating temperature and reaction rate is the Arrhenius equation. This equation (27) may be integrated and rewritten as Eqs. (31) and (32). 

Code of Federal Regulations, Title 21, Food and Drugs, Part 211, Current good manufacturing practice for finished pharmaceuticals, Subpart I, 211.166 Stability Testing. 

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... 

In summary, TLC analysis plays a critical role in the drug development process. Many instruments are available, and the technique is used for both quantitative and qualitative testing. i f determination, identity testing, and stability testing are just a few ways to utilize TLC. 

Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals Notice Stability testing of new drug substances and products Stability testing Stability testing... 

Finally, the protein assay for the drug product will also be used for realtime and accelerated stability testing if it has been validated to be stability indicating. A stability-indicating protein concentration method usually translates to a method that can reveal how much protein can be recovered from the dosage form. Many protein instabilities result in precipitation of the protein and adsorption to the container. An instability that results in only a modification of the protein structure but not in loss of protein from solution will not be detected by a sequence-independent protein assay such as a colorimetric assay. 

ICH Guidance for Industry Topic Q 1 A Stability testing of New Drug Substances and Products, 2003. 

Approximately 300 drugs were tested in aqueous solubility, log D, apparent permeability and metabolic stability assays. Compounds having low values for solubility, apparent permeability, or metabolic stability, or extreme log D values were flagged. The frequency of compounds with flags in each human bioavailability (%) bin is shown. 

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