Stability testing pharmaceutical

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

ICH Expert Working Group, Q1A Stability Testing of New Drug Substances and Products, International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use, 1994. 

JE Tingstad Physical stability testing of pharmaceuticals. J Pharm Sci 53(8) 955-962, 1964. 

There are three documents that give guidance on the design and conduct of in-use stability tests the EMEA/CVMP/127/95 final (adopted March 1996), CPMP/QWP/2570/98 (a concept paper adopted in November 1998) and CPMP/QWP/2934/99 draft (released for comment in December 1999). The studies undertaken may be discussed in the development pharmaceutics or the stability section of the dossier. 

There are numerous types of TLC testing done in the pharmaceutical industry, which are quantitative in nature. Release testing or purity evaluation, stability testing, and LOD are the three that will be addressed here. 

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... 

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... 

Dissolution is one of the most time-consuming tests in stability testing, clinical release, and process support of pharmaceutical dosage... 

Stability testing of drug compound Stability testing of pharmaceutical formulations and packagings... 

World Health Organization (WHO) (2006), Stability testing of active substances and pharmaceutical products, Working Document QAS/06.179, WHO, Geneva. 

An underlying assumption of the Arrhenius equation is that the reaction mechanism does not change as a function of temperature. Since accelerated stability testing of pharmaceutical products normally employs a narrow range of temperature, it is often difficult to detect nonlinearity in the Arrhenius plot from experimental data, even though such nonlinearity is expected from the reaction mechanism [7]. 

New Molecular Entity — An active pharmaceutical substance not previously contained in any drug product registered with the national or regional authority concerned. A new salt, ester, or noncovalent bond derivative of an approved drug substance is considered a new molecular entity for the purpose of stability testing under this guidance. 

The so-called storage stability test is a standard test that is used across many different fields—e.g., the pharmaceutical, cosmetic, and food industries. The test is popular because it yields precise information about the long-term shelf life of emulsions. In this test, emulsions are stored under conditions that are applicable to those encountered in the actual production/consumption situation. It should be noted that the presented test protocol is time consuming and requires sampling over an extended period of time. In the... 

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