Tag: API impurities

API Manufacturing: SOP for Vacuum Drying Procedure – V 2.0 Standard Operating Procedure for Vacuum Drying Procedure in API Manufacturing Department API Manufacturing SOP No. SOP/API/065/2025 Supersedes SOP/API/065/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a standard and validated procedure for drying active…

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API Manufacturing: SOP for Tray Loading for Drying – V 2.0 Standard Operating Procedure for Tray Loading for Drying in API Manufacturing Department API Manufacturing SOP No. SOP/API/064/2025 Supersedes SOP/API/064/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define the procedure for tray loading of…

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API Manufacturing: SOP for Polymorph Screening Method – V 2.0 Standard Operating Procedure for Polymorph Screening Method in API Manufacturing Department API Manufacturing SOP No. SOP/API/063/2025 Supersedes SOP/API/063/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a standard and scientifically robust procedure for polymorph…

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API Manufacturing: SOP for Seeding Techniques in Crystallization – V 2.0 Standard Operating Procedure for Seeding Techniques in Crystallization in API Manufacturing Department API Manufacturing SOP No. SOP/API/062/2025 Supersedes SOP/API/062/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define a standardized procedure for implementing seeding…

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API Manufacturing: SOP for Crystallization Process Control – V 2.0 Standard Operating Procedure for Crystallization Process Control in API Manufacturing Department API Manufacturing SOP No. SOP/API/061/2025 Supersedes SOP/API/061/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish a standard and validated procedure for carrying out…

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API Manufacturing: SOP for Use of Cooling Towers and Condensers in Recovery – V 2.0 Standard Operating Procedure for Use of Cooling Towers and Condensers in Recovery Process in API Manufacturing Department API Manufacturing SOP No. SOP/API/060/2025 Supersedes SOP/API/060/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1….

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API Manufacturing: SOP for Emergency Handling in Solvent Area – V 2.0 Standard Operating Procedure for Emergency Handling in Solvent Area in API Manufacturing Department API Manufacturing SOP No. SOP/API/059/2025 Supersedes SOP/API/059/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define the emergency handling procedures…

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API Manufacturing: SOP for Equipment Cleaning and Validation in Solvent Units – V 2.0 Standard Operating Procedure for Equipment Cleaning and Validation in Solvent Units in API Manufacturing Department API Manufacturing SOP No. SOP/API/058/2025 Supersedes SOP/API/058/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To establish…

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API Manufacturing: SOP for Monitoring of Recovered Solvent Odor and Clarity – V 2.0 Standard Operating Procedure for Monitoring of Recovered Solvent Odor and Clarity in API Manufacturing Department API Manufacturing SOP No. SOP/API/057/2025 Supersedes SOP/API/057/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define…

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API Manufacturing: SOP for Solvent Transfer Using Pumps – V 2.0 Standard Operating Procedure for Solvent Transfer Using Pumps in API Manufacturing Department API Manufacturing SOP No. SOP/API/056/2025 Supersedes SOP/API/056/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To define the procedure for the safe and…

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