Stability testing, drugs

Yang W-H, Roy SB. Projection of tentative expiry date from one-point accelerated stability testing. Drug Dev Ind Pharm 1980 6(6) 591-604. 

Yang W. Errors in the estimation of the activation energy and the projected shelf life in employing an incorrect kinetic order in an accelerated stability test. Drug Dev Ind Pharm 1981 7 717-738. 

H. P. Yuan and D. C. Locke, HPLC method for the determination of diphenhydramine in liquid and solid drug dosage forms and its application to stability testing, Drug Dev. Ind. Pharm., 77 2319 (1991). 

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... 

Davies, O. L., and Hudson, H. E., Stability of Drugs—Accelerated Storage Tests, Chapter 21B in Statistics in the Pharmaceutical Industry, C. R. Buncher and J.-Y. Tsay, Eds., Marcel Dekker, 1994. 

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. 

Regulatory bodies such as the Food and Drug Administration (FDA) in the United States require the identification of all impurities above the 0.1% level in formulated pharmaceuticals. Once identified, the structure of the impurity is typically confirmed through synthesis to provide absolute structure identification and for use as standards in subsequent quality assurance analyses. Together, LC-MS and LC-NMR play important roles in stability testing. For example, parallel analysis by LC-NMR and LC-MS was used for the rapid structure elucidation of an unknown impurity in 5-aminosalicylic acid, which is marketed for the treatment of acute ulcerative colitis and Chron s disease [57]. In another study, Fukutsu et al. [58] used a combination... 

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