Petrolatum

Petrolatum is a mixture of saturated hydrocarbon commonly used as ointment base in topical formulation. A familiar everyday example of petrolatum is Vaseline. Petrolatum comes with a wide variety of brands, manufacturers, and grades. I have personally used Penreco Ultima, Snow White, and Super White for numerous formulations with decent outcomes. Application in Formulation Among …

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Design Solubility/Stability Study

In pre-formulation and early phase formulation development, formulation scientists rely on solubility and stability of API to craft preliminary formulas. A simple and effective design of solubility/stability study will help to obtain the necessary data with sufficient accuracy under a tight timeline. Determination of Solubility The solubility of an API in a given set of …

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FDA BE Guidance – Injectables

To facilitate generic drug product availability and assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs. After more than a decade in action, this …

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Safety Assessment of Using Nitrogen Gas in Confined Area

Nitrogen gas is a common inert protecting gas during pharmaceutical manufacturing. It is supplied in either compressed gas cylinders or liquid nitrogen dewars. Continuous usage of nitrogen gas in confined area with limit ventilation or air exchange can pose a serious safety hazard to operators. This article illustrates a practical example of engineering assessment of …

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