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9 Steps in Pharmaceutical Nitrosamine Risk Assessment
15
Sep
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9 Steps in Pharmaceutical Nitrosamine Risk Assessment

Nitrosamine risk assessment has become a critical part of pharmaceutical impurity control. Since nitrosamine impurities were first identified as a major regulatory concern in medicines, the scientific focus has expanded from well-known small-molecule nitrosamines such as NDMA and NDEA to a much broader range of potential impurities, including nitrosamine drug substance-related impurities (NDSRIs). The challenge […]
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Before Method Validation: Signs Your Analytical Method Is Not Ready Yet
01
Sep
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Before Method Validation: Signs Your Analytical Method Is Not Ready Yet

Analytical method validation should confirm that a method is fit for its intended purpose. It should not be the stage where fundamental method-development problems are discovered. Yet analytical procedures sometimes enter formal validation while questions remain around specificity, sample preparation, solution stability, robustness, chromatographic resolution, system suitability, or the intended analytical range. The result can […]
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Cleaning Validation and Cross-Contamination Risk: What You Cannot See Can Still Carry Over
18
Aug
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Cleaning Validation and Cross-Contamination Risk: What You Cannot See Can Still Carry Over

In pharmaceutical development, a piece of equipment can look clean and still carry residues from the product manufactured before it. A thin film of active pharmaceutical ingredient (API), excipient, cleaning agent, degradation product, or microbial contamination may not be visible to the human eye. Yet if that residue remains on a product-contact surface, it may […]
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Rheology in Topical Formulations: Why Texture Is a Critical Performance Parameter
14
Aug
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Rheology in Topical Formulations: Why Texture Is a Critical Performance Parameter

Topical pharmaceutical products are expected to do more than contain the correct concentration of an active pharmaceutical ingredient (API). A cream, gel, ointment, or lotion must also maintain its physical structure, spread appropriately on the skin, deliver the drug consistently, remain stable throughout its shelf life, and provide an acceptable application experience. Many of these […]
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Choosing the Right Receptor Medium for IVRT and IVPT Studies
01
Aug
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Choosing the Right Receptor Medium for IVRT and IVPT Studies

In vitro release testing (IVRT) and in vitro permeation testing (IVPT) are widely used to characterize topical and transdermal drug products throughout formulation development, quality assessment, and comparative performance studies. While parameters such as membrane selection, diffusion cell configuration, sampling intervals, and temperature control receive considerable attention, one experimental factor has an equally important influence […]
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