Tag: SOP for analytical method lifecycle management

Analytical Method Development: Sink Condition Determination SOP – V 2.0 Standard Operating Procedure for Determining Sink Conditions in Dissolution Testing Department Analytical Method Development SOP No. SOP/AMD/102/2025 Supersedes SOP/AMD/102/2022 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 procedure for determining sink conditions…

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Analytical Method Development: Dissolution Media Selection SOP – V 2.0 Standard Operating Procedure for Selection of Dissolution Media in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/101/2025 Supersedes SOP/AMD/101/2022 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 structured approach for…

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Analytical Method Development: Comparison of FTIR Spectra in AMD – V 2.0 SOP for Comparative Evaluation of FTIR Spectra in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/100/2025 Supersedes SOP/AMD/100/2022 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 defines the methodology for…

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Analytical Method Development: Specificity Testing by FTIR – V 2.0 SOP for Specificity Testing by FTIR in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/099/2025 Supersedes SOP/AMD/099/2022 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 defines the procedure for performing specificity testing…

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Analytical Method Development: KBr Pellet Method Optimization – V 2.0 SOP for Optimization of KBr Pellet Method in FTIR Analysis Department Analytical Method Development SOP No. SOP/AMD/098/2025 Supersedes SOP/AMD/098/2022 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 procedure for optimizing the potassium…

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Analytical Method Development: ATR-FTIR Method SOP – V 2.0 SOP for Attenuated Total Reflectance (ATR) FTIR Analysis in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/097/2025 Supersedes SOP/AMD/097/2022 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 defines the standard procedure for conducting…

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Analytical Method Development: Development of FTIR Fingerprint Spectrum – V 2.0 SOP for Development of FTIR Fingerprint Spectrum for Pharmaceutical Substances Department Analytical Method Development SOP No. SOP/AMD/096/2025 Supersedes SOP/AMD/096/2022 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 procedure for developing…

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Analytical Method Development: Preparation of Calibration Curve in UV – V 2.0 SOP for Preparation of Calibration Curve in UV Spectrophotometric Analysis Department Analytical Method Development SOP No. SOP/AMD/095/2025 Supersedes SOP/AMD/095/2022 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 a systematic approach to…

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Analytical Method Development: Wavelength Scanning and Selection SOP – V 2.0 SOP for Wavelength Scanning and Selection in UV Method Development Department Analytical Method Development SOP No. SOP/AMD/094/2025 Supersedes SOP/AMD/094/2022 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 procedure for scanning…

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Analytical Method Development: Linearity Study Using UV – V 2.0 SOP for Conducting Linearity Studies in UV Spectrophotometric Method Development Department Analytical Method Development SOP No. SOP/AMD/093/2025 Supersedes SOP/AMD/093/2022 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 defines the procedure for performing linearity studies…

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