Tag: SOP for analytical calculations

Analytical Method Development: Solvent Selection for NMR – V 2.0 Standard Operating Procedure for Solvent Selection for NMR in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/113/2025 Supersedes SOP/AMD/113/2022 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 criteria and procedure…

Read More “Analytical Method Development: Solvent Selection for NMR – V 2.0” »

Analytical Method Development: Interpretation of NMR Spectra in AMD – V 2.0 Standard Operating Procedure for Interpretation of NMR Spectra in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/112/2025 Supersedes SOP/AMD/112/2022 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…

Read More “Analytical Method Development: Interpretation of NMR Spectra in AMD – V 2.0” »

Analytical Method Development: Development of 1H NMR Method – V 2.0 Standard Operating Procedure for Development of 1H NMR Method in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/111/2025 Supersedes SOP/AMD/111/2022 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 systematic…

Read More “Analytical Method Development: Development of 1H NMR Method – V 2.0” »

Analytical Method Development: Peak Identification by m/z Ratios – V 2.0 Standard Operating Procedure for Peak Identification by m/z Ratios in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/110/2025 Supersedes SOP/AMD/110/2022 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…

Read More “Analytical Method Development: Peak Identification by m/z Ratios – V 2.0” »

Analytical Method Development: Impurity Profiling Using LC-MS – V 2.0 Standard Operating Procedure for Impurity Profiling Using LC-MS in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/109/2025 Supersedes SOP/AMD/109/2022 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 a standardized process for…

Read More “Analytical Method Development: Impurity Profiling Using LC-MS – V 2.0” »

Analytical Method Development: Mass Spectral Fragmentation Analysis SOP – V 2.0 Standard Operating Procedure for Mass Spectral Fragmentation Analysis in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/108/2025 Supersedes SOP/AMD/108/2022 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…

Read More “Analytical Method Development: Mass Spectral Fragmentation Analysis SOP – V 2.0” »

Analytical Method Development: LC-MS Method Development – V 2.0 Standard Operating Procedure for LC-MS Method Development in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/106/2025 Supersedes SOP/AMD/106/2022 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 comprehensive procedure for the development…

Read More “Analytical Method Development: LC-MS Method Development – V 2.0” »

Analytical Method Development: Method Transfer for Dissolution Studies – V 2.0 Standard Operating Procedure for Method Transfer of Dissolution Studies in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/105/2025 Supersedes SOP/AMD/105/2022 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 step-by-step…

Read More “Analytical Method Development: Method Transfer for Dissolution Studies – V 2.0” »

Analytical Method Development: Development of Drug Release Profile – V 2.0 Standard Operating Procedure for Development of Drug Release Profile in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/104/2025 Supersedes SOP/AMD/104/2022 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…

Read More “Analytical Method Development: Development of Drug Release Profile – V 2.0” »

Analytical Method Development: Apparatus Selection for Dissolution – V 2.0 Standard Operating Procedure for Selection of Dissolution Apparatus in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/103/2025 Supersedes SOP/AMD/103/2022 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 standardized approach for…

Read More “Analytical Method Development: Apparatus Selection for Dissolution – V 2.0” »