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Each strength of a drug product, and each primary package and closure system in which it is distributed must be supported by stability testing.


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Pharmaceutical products delivered in multidose containers require in-use stability studies. Moreover, those pharmaceutical products requiring dilution or reconstitution prior to use also require in-use stability studies.

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In-use stability can be described as how well a pharmaceutical product remains stable during in-use within a particular closure system. During the in-use period, the pharmaceutical product remains within its physical, chemical, and microbiological specifications and retains its safety, efficacy, and performance.

What is a stability study and what is its purpose?

Even though the different guidelines are available, specific information for in-use stability studies that can smoothly guide applicant for regulatory submission is not at par. In-use stability studies should be performed in accordance to the various guidelines published by the regulatory agencies or by appropriate, justifiable ways that satisfy the regulators. This review explores current in-use stability guidelines, numerous examples of performed in-use stability studies, challenges to in-use stability and other relevant aspects.

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Stability testing requirements for otc & drug products in the usa

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Guideline for the stability testing of nonprescription (otc) drug products not regulated by an nda/anda

Received 13 May Abstract Pharmaceutical products delivered in multidose containers require in-use stability studies. Keywords: Dilution guidelines in-use shelf life in-use stability multidose container opening storage.

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Because of the unique requirements associated with new OTC monograph drug products, the direct application of the FDA and ICH guidance is sometimes inappropriate and impractical.


Publishing of 21 CFR Part - Current Good Manufacturing Practice for Finished Pharmaceuticals established requirements concerning the expiration date on a drug product and stability testing to assure the appropriateness of that date.


Determining product shelf life is a regulatory requirement for pharmaceuticals and many other regulated consumer products.