Stability program dissolution

QA requires the efficient analysis of many samples to support routine production release and stability programs. Methods are typically established in the analytical development group. Efficiency and convenience issues, including the speed of media preparation and the relative convenience of data handling and documentation, are important here. While compliance is important in all aspects of the pharmaceutical industry, QA functions must approach compliance perfection. Depending upon the facility, the automated apparatus may be tailored to specific methods with fixed configurations. Dissolution methods may be routine enough that a custom system, optimized for productivity, may be justified. Compliance of USP and use of industry standard apparatus is important to maintain compatibility with other company laboratories or in the case contract laboratory services are required. 

The stability profile of each product, in its Australian sales pack, should be available. Where it is not, it should be determined according to a written stability program. The profile should be verified at appropriate intervals by supplementary testing of further batches of product. The program should include dissolution, microbiological and preservative efficacy testing where appropriate. 

Heimann, R. B. 1985. Stability and dissolution of Ca- and Na-bentonites. Proceedings of the I9th Information Meeting of the Nuclear Fuel Waste Management Program, September 1985, Pinawa, Manitoba. Atomic Energy of Canada Ltd, 2. 

Particle size and shape are important attributes of drug substances that can affect the dissolution rate, bioavailability, and the processing of oral solid dosage forms and the physical stability of semi-solid dosage forms. During manufacture of the bulk drug substance, the recrystallization conditions required to prepare a particular salt will inevitably influence the particle size and crystal habit conditions should be established early in the development program that routinely yield material with consistent characteristics. 

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