Stability testing

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First of all I would like to apologize for not being blogging since a long time. I am some what hectic with M.pharm project submission and job searching by moving to other areas. My mind is not stable and could not concentrate on blogging. I would like to share some of my knowledge on stability testing and its significance.

Stability testing is generally performed according to ICH guidelines. After successfully formulating a bulk drug or formulation, it is necessary to ensure that it is stable enough under the conditions proposed. Stability includes all types of stability either it is physical, chemical or biological. So there is a need to perform stability testing at developmental stage itself. An unstable bulk drug or formulation is useless. Stability testing is performed along with the proposed packing material. After successfully designing a drug or dosage form, shelf life is to be established according to the guidelines proposed by ICH. In addition to the stability testing at developmental stages, it also serves as a quality control parameter. Our of trend (OOT) and out of specification (OOS) are the two common terms used in pharmaceutical products stability testing. As the names themselves indicate, the term OOT is used when the stability testing results are different from that of previous batches. The term OOS is used when when the results completely deviate from the specifications. It is important to identify these issues statistically. After storing the drug products at specific temperatures proposed according to the guidelines, frequent analysis is to be carried out at regular time intervals. Hence, stability testing generates huge amount of data. Software for stability testing is available to maintain and analyze such data. Statistical designs like composite design, matrixing and bracketing are proposed to reduce the complexity involved.

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G.Sailesh's picture
Author: G.Sailesh

Comments

Sandhya Sravya malla's picture

good one regards sravya
Siva Mavuduru's picture

Hi sailesh Good one What about tablets? do they need stability tests?

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