The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To define a validated and regulatory-compliant procedure for the development and qualification of methods used for the detection and quantification of subvisible particulate matter in injectable pharmaceutical products using light obscuration and microscopic techniques.
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To establish a validated procedure for the identification and quantification of residual solvents in parenteral pharmaceutical products using Gas Chromatography (GC), ensuring compliance with ICH Q3C guidelines and pharmacopeial standards (USP ).
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To define the procedure for the identification, characterization, and monitoring of the polymorphic form of sterile active pharmaceutical ingredients (APIs) using validated analytical techniques to ensure batch consistency and product stability.
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To define a validated procedure for developing and executing an assay method using High Performance Liquid Chromatography (HPLC) for multicomponent tablets containing two or more active pharmaceutical ingredients (APIs), ensuring each component is accurately quantified without interference.
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To establish a standardized and validated procedure for the evaluation of blend uniformity of active pharmaceutical ingredients (APIs) in powder blends prior to compression or encapsulation, using HPLC or UV spectrophotometry.
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To define a validated and standardized procedure for determining content uniformity of active pharmaceutical ingredient (API) in individual capsule dosage units using HPLC or UV-visible spectroscopy as per pharmacopeial and ICH requirements.
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To define a validated and standardized procedure for the development and execution of a disintegration time testing method for solid oral dosage forms such as tablets and capsules, as per pharmacopeial standards.
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To establish a standardized procedure for the development and validation of a dissolution method for delayed release tablets using USP Apparatus I (Basket) or II (Paddle), involving staged media to simulate gastrointestinal conditions.
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To establish a validated and standardized analytical procedure for the assay of active pharmaceutical ingredients (APIs) in granules for oral suspension using UV-Visible Spectrophotometry or High Performance Liquid Chromatography (HPLC).
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To define the procedure for identifying and confirming the presence and composition of coating materials applied to pharmaceutical solid oral dosage forms using analytical techniques such as FTIR, UV, HPLC, and thermal analysis.
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