The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To define the procedure for evaluating the uniformity of dosage units in semi-solid formulations such as creams, ointments, and gels, ensuring consistency of active ingredient distribution within and across containers.
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To define a standardized and validated procedure for measuring the spreadability of ointment formulations using a slide-based mechanical apparatus to assess ease of application and formulation consistency.
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To establish a validated procedure for determining microbial load in pharmaceutical cream formulations, including enumeration of total aerobic microbial count (TAMC), total combined yeasts and molds count (TYMC), and absence of specified pathogens as per pharmacopeial requirements.
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To establish a standardized method for the determination of particle size distribution in lotion formulations using laser diffraction or optical microscopy, ensuring uniformity, aesthetic properties, and product performance.
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To establish a standard method for assessing the stability of pharmaceutical emulsions through a combination of physical observation, droplet size analysis, and accelerated stress tests to ensure formulation integrity over shelf-life.
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To establish a validated procedure for the identification of cream base components such as emulsifying agents, emollients, and waxes using Fourier Transform Infrared (FTIR) Spectroscopy with Attenuated Total Reflectance (ATR) technique.
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To define a validated procedure for determining the physical stability of pharmaceutical gels by identifying and quantifying phase separation under accelerated and stress conditions, ensuring consistency in formulation performance and shelf-life.
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To define a validated procedure for evaluating the homogeneity of active pharmaceutical ingredient (API) in topical formulations such as creams, gels, and ointments, ensuring consistent drug distribution throughout the dosage unit.
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To establish a standard and validated procedure for developing assay methods for injectable pharmaceutical formulations using chromatographic or spectrophotometric techniques to determine the active drug content with accuracy and precision.
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To establish a standardized procedure for developing a method to measure the pH of injectable pharmaceutical products using a calibrated pH meter to ensure batch-to-batch consistency and regulatory compliance.
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