The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To describe the procedure for performing sterility testing of ophthalmic products using the membrane filtration and direct inoculation methods, ensuring products are free from viable microorganisms as per pharmacopeial requirements.
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To define the procedure for conducting preservative efficacy testing (PET) in ophthalmic preparations (eye drops) to evaluate the effectiveness of antimicrobial preservatives in inhibiting microbial growth over a defined period as per pharmacopeial standards.
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To establish a standardized procedure for measuring the osmolarity of ophthalmic solutions using a freezing point depression osmometer, ensuring the tonicity of the product is suitable for ocular administration.
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To define the procedure for developing, optimizing, and validating an assay method for quantification of the active pharmaceutical ingredient (API) in topical formulations such as creams, ointments, and gels using High Performance Liquid Chromatography (HPLC).
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To define a validated method for testing the content uniformity of active pharmaceutical ingredients (APIs) in ointment formulations to ensure homogeneous distribution and product quality throughout the container and across batches.
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To establish a standardized procedure for conducting in-vitro release testing (IVRT) of cream formulations using a vertical diffusion cell system and quantifying the released drug through HPLC, ensuring consistent release characteristics across batches and during stability studies.
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To define the procedure for performing in-vitro drug release testing of topical gel formulations using the diffusion cell method, including setup, operation, sampling, and analysis to determine drug diffusion through a membrane over time.
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To define the procedure for accurate determination of the pH of semi-solid pharmaceutical formulations (e.g., creams, ointments, gels) to ensure consistency, stability, and compliance with product specifications.
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To define the procedure for developing and validating a method to measure the viscosity of semi-solid formulations such as creams, ointments, and gels using a Brookfield viscometer.
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To describe the procedure for conducting rheological profiling of topical semi-solid pharmaceutical formulations such as creams, gels, and ointments using a rotational rheometer to assess viscosity, shear thinning, thixotropy, and viscoelastic behavior.
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