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Vishal N. Kushare* and Pritishchandra S. Kabra


Stability of pharmaceutical may be defined as the capability of particular formulation in specific container/closer system to remain within its physical, chemical, microbiological, therapeutics and toxicological specification, Modes of Degradation. Photostability testing. Stability testing should be conducted on the dosage form packaged in the container closure system proposed for marketing. Systematic approach in presentation and evaluation of stability information, A storage statement should be established for the labelling in accordance with relevant national/regional requirements. The shelf-life, or expiration dating period, determination of shelf life. the ICH that replaces 30C/60% RH, which would allow worldwide harmonization of testing requirements to support determination of expiration dating periods for each of the four climate zones of the world.

Keywords: Stability, Photo stability, ICH, Shelf life.

[Full Text Article]

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