Tag: SOP for method reproducibility

Analytical Method Development: SOP for In-Vitro Release Testing for Topical Products – V 2.0 Standard Operating Procedure for In-Vitro Release Testing of Topical Drug Products Department Analytical Method Development SOP No. SOP/AMD/163/2025 Supersedes SOP/AMD/163/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP provides a…

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Analytical Method Development: SOP for Nanoformulations Analysis Method – V 2.0 Standard Operating Procedure for Analytical Method Development for Nanoformulations Department Analytical Method Development SOP No. SOP/AMD/162/2025 Supersedes SOP/AMD/162/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP describes the standardized approach for developing, optimizing,…

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Analytical Method Development: SOP for Analytical Method for Liposomes – V 2.0 Standard Operating Procedure for Analytical Method Development for Liposomal Drug Products Department Analytical Method Development SOP No. SOP/AMD/161/2025 Supersedes SOP/AMD/161/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose To establish a standardized procedure for…

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Analytical Method Development: SOP for Oxidative Degradation Pathway Profiling – V 2.0 Standard Operating Procedure for Oxidative Degradation Pathway Profiling in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/139/2025 Supersedes SOP/AMD/139/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP outlines the process…

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Analytical Method Development: SOP for Development of Photostability Testing Methods – V 2.0 Standard Operating Procedure for Development of Photostability Testing Methods in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/138/2025 Supersedes SOP/AMD/138/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP provides…

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Analytical Method Development: Use of LC-MS for Unknown Degradation Products – V 2.0 Standard Operating Procedure for Use of LC-MS in Identifying Unknown Degradation Products in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/137/2025 Supersedes SOP/AMD/137/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose…

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Analytical Method Development: SOP for Isolation and Characterization of Unknown Impurities – V 2.0 Standard Operating Procedure for Isolation and Characterization of Unknown Impurities in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/136/2025 Supersedes SOP/AMD/136/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This…

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Analytical Method Development: Identification of Process Related Impurities – V 2.0 Standard Operating Procedure for Identification of Process Related Impurities in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/135/2025 Supersedes SOP/AMD/135/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP outlines the methodology…

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Analytical Method Development: Identification of Impurities in API – V 2.0 Standard Operating Procedure for Identification of Impurities in Active Pharmaceutical Ingredients (API) Department Analytical Method Development SOP No. SOP/AMD/134/2025 Supersedes SOP/AMD/134/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose To outline a standardized procedure for…

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Analytical Method Development: Aseptic Technique SOP for AMD – V 2.0 Standard Operating Procedure for Aseptic Technique in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/133/2025 Supersedes SOP/AMD/133/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP outlines aseptic techniques to be followed…

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