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Pharma Stability: Insights, Guidelines, and Expertise

Stability Studies SOP

SOP for Freeze Thaw Studies

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Procedure for Conducting Freeze Thaw Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for conducting freeze thaw studies. These studies are conducted to evaluate the stability of pharmaceutical products when subjected to cycles of freezing and thawing. Scope This SOP applies to all pharmaceutical products undergoing freeze thaw…

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Stability Studies SOP

SOP for Excipient Compatibility Studies

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Procedures for Conducting Excipient Compatibility Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for conducting excipient compatibility studies. These studies are performed to evaluate the interaction between active pharmaceutical ingredients (APIs) and excipients used in the formulation. Scope This SOP applies to all excipient compatibility studies conducted within…

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Stability Studies SOP

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  • Include Microbial Limits Testing in Stability Studies Where Applicable

    Understanding the Tip: What is microbial limits testing in stability studies: Microbial limits testing evaluates the total microbial count and the presence of specific objectionable… Read more

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