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Tag: API crystallization

API Manufacturing: SOP for Monitoring of Recovered Solvent Odor and Clarity – V 2.0

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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 V 2.0

API Manufacturing: SOP for Solvent Transfer Using Pumps – V 2.0

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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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API Manufacturing V 2.0

API Manufacturing: SOP for Operator Training on Solvent Safety – V 2.0

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API Manufacturing: SOP for Operator Training on Solvent Safety – V 2.0 Standard Operating Procedure for Operator Training on Solvent Safety in API Manufacturing Department API Manufacturing SOP No. SOP/API/055/2025 Supersedes SOP/API/055/2022 Page No. Page 1 of 10 Issue Date 13/04/2025 Effective Date 15/04/2025 Review Date 13/04/2026 1. Purpose To provide a standardized framework for…

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API Manufacturing V 2.0

API Manufacturing: SOP for Fire Hazard Control Measures – V 2.0

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API Manufacturing: SOP for Fire Hazard Control Measures – V 2.0 Standard Operating Procedure for Fire Hazard Control Measures in API Manufacturing Department API Manufacturing SOP No. SOP/API/054/2025 Supersedes SOP/API/054/2022 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 fire hazard control measures in API…

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API Manufacturing V 2.0

API Manufacturing: SOP for Handling of Mixed Solvent Streams – V 2.0

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API Manufacturing: SOP for Handling of Mixed Solvent Streams – V 2.0 Standard Operating Procedure for Handling of Mixed Solvent Streams in API Manufacturing Department API Manufacturing SOP No. SOP/API/053/2025 Supersedes SOP/API/053/2022 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 standard procedure for…

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API Manufacturing V 2.0

API Manufacturing: SOP for Calibration of Storage Vessels – V 2.0

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API Manufacturing: SOP for Calibration of Storage Vessels – V 2.0 Standard Operating Procedure for Calibration of Storage Vessels in API Manufacturing Department API Manufacturing SOP No. SOP/API/052/2025 Supersedes SOP/API/052/2022 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 method for the calibration…

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API Manufacturing V 2.0

API Manufacturing: SOP for Use of Activated Carbon in Recovery Process – V 2.0

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API Manufacturing: SOP for Use of Activated Carbon in Recovery Process – V 2.0 Standard Operating Procedure for Use of Activated Carbon in Recovery Process in API Manufacturing Department API Manufacturing SOP No. SOP/API/051/2025 Supersedes SOP/API/051/2022 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 V 2.0

API Manufacturing: SOP for Documentation and Yield Calculation for Solvent Recovery – V 2.0

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API Manufacturing: SOP for Documentation and Yield Calculation for Solvent Recovery – V 2.0 Standard Operating Procedure for Documentation and Yield Calculation for Solvent Recovery in API Manufacturing Department API Manufacturing SOP No. SOP/API/050/2025 Supersedes SOP/API/050/2022 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 V 2.0

API Manufacturing: SOP for Disposal of Non-Recoverable Solvents – V 2.0

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API Manufacturing: SOP for Disposal of Non-Recoverable Solvents – V 2.0 Standard Operating Procedure for Disposal of Non-Recoverable Solvents in API Manufacturing Department API Manufacturing SOP No. SOP/API/049/2025 Supersedes SOP/API/049/2022 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 safe, traceable, and…

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API Manufacturing V 2.0

API Manufacturing: SOP for Monitoring of Solvent Recovery Efficiency – V 2.0

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API Manufacturing: SOP for Monitoring of Solvent Recovery Efficiency – V 2.0 Standard Operating Procedure for Monitoring of Solvent Recovery Efficiency in API Manufacturing Department API Manufacturing SOP No. SOP/API/048/2025 Supersedes SOP/API/048/2022 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 consistent and standardized…

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API Manufacturing V 2.0

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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