Tag: SOP for method transfer

Analytical Method Development: SOP for API Distribution Analysis in Blend – V 2.0 Standard Operating Procedure for API Distribution Analysis in Blend in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/292/2025 Supersedes SOP/AMD/292/2022 Page No. Page 1 of 11 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To define a…

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Analytical Method Development: SOP for Determination of Enteric Coating Integrity – V 2.0 Standard Operating Procedure for Determination of Enteric Coating Integrity in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/291/2025 Supersedes SOP/AMD/291/2022 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 Residual Solvent Detection in Granules – V 2.0 Standard Operating Procedure for Residual Solvent Detection in Granules in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/290/2025 Supersedes SOP/AMD/290/2022 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 Moisture Content Testing in Powder Formulations – V 2.0 Standard Operating Procedure for Moisture Content Testing in Powder Formulations in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/289/2025 Supersedes SOP/AMD/289/2022 Page No. Page 1 of 10 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 Color Uniformity Analysis in Coated Tablets – V 2.0 Standard Operating Procedure for Color Uniformity Analysis in Coated Tablets in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/288/2025 Supersedes SOP/AMD/288/2022 Page No. Page 1 of 10 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 Coating Materials – V 2.0 Standard Operating Procedure for Identification of Coating Materials in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/287/2025 Supersedes SOP/AMD/287/2022 Page No. Page 1 of 11 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To define the procedure for…

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Analytical Method Development: SOP for Assay Development for Granules for Suspension – V 2.0 Standard Operating Procedure for Assay Method Development for Granules for Suspension in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/286/2025 Supersedes SOP/AMD/286/2022 Page No. Page 1 of 11 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose…

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Analytical Method Development: SOP for Dissolution Method for Delayed Release Tablets – V 2.0 Standard Operating Procedure for Dissolution Method Development for Delayed Release Tablets in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/285/2025 Supersedes SOP/AMD/285/2022 Page No. Page 1 of 12 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose…

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Analytical Method Development: SOP for Disintegration Time Testing Method Development – V 2.0 Standard Operating Procedure for Disintegration Time Testing Method Development in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/284/2025 Supersedes SOP/AMD/284/2022 Page No. Page 1 of 10 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 Content Uniformity in Capsules – V 2.0 Standard Operating Procedure for Content Uniformity Testing in Capsules in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/283/2025 Supersedes SOP/AMD/283/2022 Page No. Page 1 of 11 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To define a validated…

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