Key information is needed for excipients and their potential impact on continuous manufacturing processes. An essential factor to consider when developing a robust continuous manufacturing (CM) ...

Nitrosamines arise via nitrosating agents (nitrites, NO2/NOx, nitrous acids/oxides) reacting with secondary/tertiary amines or some amides, yielding high-risk N-nitroso compounds. Regulatory actions ...

Excipients, the ‘inactive’ substances that are mixed with active pharmaceutical ingredients to achieve drug formulation requirements, don’t get much love. But with innovations in medicinal chemistry ...

Pharmaceutical formulations consist of active pharmaceutical ingredients (APIs) and excipients. Appropriate excipient selection is critical to the final quality of pharmaceutical products. When ...

Regulatory Guidelines for API-Excipient Compatibility Studies Summary Pharmaceutical excipients have important functions such as serving as carriers, improving drug stability, solubilization and ...

The excipients benzyl alcohol, propylene glycol and ethanol are present in medications used in the neonatal intensive care unit. Exposure to high levels can have adverse effects in a neonatal ...

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PCCA Adds to Its Family of USP Verified Excipient Compounding Bases · GlobeNewswire Inc. “This verification demonstrates our continued commitment to our ‘Quality without Compromise’ core value,” said ...

The proliferation of quality-management standards in manufacturing is such that each new document seems like one step deeper into an arcane world of industrial measurement. But a new standard from the ...

A vital parameter in pharmaceutical samples is loss on drying, which is utilized to determine the amount of water and other volatile solvents in a sample, as it can impact a product's stability, ...

The Indian excipient market is growing at 10 to 12% as against the global growth rate of 5 to 7%. The Indian excipient manufacturers have raised alarm over the surging prices of major excipients by 30 ...

In the not-too-distant future, the excipient sector in India is expected to boom. India’s fast-rising pharmaceutical market, increasing demand for novel formulations, accessibility, and availability ...