Tag: SOP for reference standard handling

Analytical Method Development: SOP for Blend Uniformity Testing Method – V 2.0 Standard Operating Procedure for Blend Uniformity Testing Method in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/282/2025 Supersedes SOP/AMD/282/2022 Page No. Page 1 of 11 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To establish a standardized and…

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Analytical Method Development: SOP for Assay Method for Multicomponent Tablet – V 2.0 Standard Operating Procedure for Assay Method Development for Multicomponent Tablet in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/281/2025 Supersedes SOP/AMD/281/2022 Page No. Page 1 of 13 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To define…

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Analytical Method Development: SOP for Characterization of Polymorphic Form in Sterile API – V 2.0 Standard Operating Procedure for Characterization of Polymorphic Form in Sterile API in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/280/2025 Supersedes SOP/AMD/280/2022 Page No. Page 1 of 12 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1….

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Analytical Method Development: SOP for Determination of Residual Solvents in Parenterals – V 2.0 Standard Operating Procedure for Determination of Residual Solvents in Parenterals in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/279/2025 Supersedes SOP/AMD/279/2022 Page No. Page 1 of 12 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To…

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Analytical Method Development: SOP for Development of Subvisible Particulate Matter Test – V 2.0 Standard Operating Procedure for Development of Subvisible Particulate Matter Test in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/278/2025 Supersedes SOP/AMD/278/2022 Page No. Page 1 of 11 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To…

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Analytical Method Development: SOP for Stability-Indicating Method for Lyophilized Injections – V 2.0 Standard Operating Procedure for Stability-Indicating Method for Lyophilized Injections in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/277/2025 Supersedes SOP/AMD/277/2022 Page No. Page 1 of 13 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To define a…

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Analytical Method Development: SOP for Preservative Quantification Method Development – V 2.0 Standard Operating Procedure for Preservative Quantification Method Development in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/276/2025 Supersedes SOP/AMD/276/2022 Page No. Page 1 of 12 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To outline a validated and…

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Analytical Method Development: SOP for Benzyl Alcohol Detection in Parenterals – V 2.0 Standard Operating Procedure for Benzyl Alcohol Detection in Parenterals in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/275/2025 Supersedes SOP/AMD/275/2022 Page No. Page 1 of 11 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To establish a…

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Analytical Method Development: SOP for Compatibility Testing of Actives with Diluent – V 2.0 Standard Operating Procedure for Compatibility Testing of Actives with Diluent in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/274/2025 Supersedes SOP/AMD/274/2022 Page No. Page 1 of 12 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To…

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Analytical Method Development: SOP for Identification of Preservatives in Multi-Dose Vials – V 2.0 Standard Operating Procedure for Identification of Preservatives in Multi-Dose Vials in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/273/2025 Supersedes SOP/AMD/273/2022 Page No. Page 1 of 11 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To…

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