Tag: Elixir regulatory guidelines

Elixir Department: SOP for Clarity and Opalescence Testing – V 2.0

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Elixir Department: SOP for Clarity and Opalescence Testing – V 2.0 Standard Operating Procedure for Clarity and Opalescence Testing of Elixir Formulations Department Elixir Department SOP No. SOP/ELX/219/2025 Supersedes SOP/ELX/219/2022 Page No. Page 1 of 7 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To describe the procedure for evaluating the clarity…

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Elixir Department: SOP for Preservative Effectiveness Testing – V 2.0

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Elixir Department: SOP for Preservative Effectiveness Testing – V 2.0 Standard Operating Procedure for Preservative Effectiveness Testing (PET) in Elixir Formulations Department Elixir Department SOP No. SOP/ELX/218/2025 Supersedes SOP/ELX/218/2022 Page No. Page 1 of 9 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define a validated method for conducting Preservative Effectiveness…

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Elixir Department: SOP for Microbial Limit Testing – V 2.0

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Elixir Department: SOP for Microbial Limit Testing – V 2.0 Standard Operating Procedure for Microbial Limit Testing of Elixir Formulations Department Elixir Department SOP No. SOP/ELX/217/2025 Supersedes SOP/ELX/217/2022 Page No. Page 1 of 9 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To describe the procedure for determining the microbial limits in…

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Elixir Department: SOP for Determination of Alcohol Content – V 2.0

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Elixir Department: SOP for Determination of Alcohol Content – V 2.0 Standard Operating Procedure for Determination of Alcohol Content in Elixir Formulations Department Elixir Department SOP No. SOP/ELX/216/2025 Supersedes SOP/ELX/216/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define a validated method for the determination…

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Elixir Department: SOP for Viscosity Measurement Using Brookfield Viscometer – V 2.0

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Elixir Department: SOP for Viscosity Measurement Using Brookfield Viscometer – V 2.0 Standard Operating Procedure for Viscosity Measurement of Elixir Using Brookfield Viscometer Department Elixir Department SOP No. SOP/ELX/215/2025 Supersedes SOP/ELX/215/2022 Page No. Page 1 of 9 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To establish a standardized method for determining…

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Elixir Department: SOP for pH Testing of Final Product – V 2.0

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Elixir Department: SOP for pH Testing of Final Product – V 2.0 Standard Operating Procedure for pH Testing of Final Elixir Product Department Elixir Department SOP No. SOP/ELX/214/2025 Supersedes SOP/ELX/214/2022 Page No. Page 1 of 7 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To lay down a standardized method for the…

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Elixir Department: SOP for Identification of API by IR Spectroscopy – V 2.0

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Elixir Department: SOP for Identification of API by IR Spectroscopy – V 2.0 Standard Operating Procedure for Identification of Active Pharmaceutical Ingredient (API) by IR Spectroscopy Department Elixir Department SOP No. SOP/ELX/213/2025 Supersedes SOP/ELX/213/2022 Page No. Page 1 of 9 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To establish a standardized…

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Elixir Department: SOP for Assay of API by HPLC – V 2.0

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Elixir Department: SOP for Assay of API by HPLC – V 2.0 Standard Operating Procedure for Assay of Active Pharmaceutical Ingredient (API) by HPLC in Elixirs Department Elixir Department SOP No. SOP/ELX/212/2025 Supersedes SOP/ELX/212/2022 Page No. Page 1 of 10 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To describe the procedure…

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Elixir Department: SOP for Sampling of Final Product for QC – V 2.0

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Elixir Department: SOP for Sampling of Final Product for QC – V 2.0 Standard Operating Procedure for Sampling of Final Product for Quality Control Testing Department Elixir Department SOP No. SOP/ELX/211/2025 Supersedes SOP/ELX/211/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the standard procedure…

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Elixir Department: SOP for Statistical Trending of IPC Data – V 2.0

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Elixir Department: SOP for Statistical Trending of IPC Data – V 2.0 Standard Operating Procedure for Statistical Trending of In-Process Control (IPC) Data Department Elixir Department SOP No. SOP/ELX/210/2025 Supersedes SOP/ELX/210/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define a systematic approach for the…

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