Securing the integrity of the excipient supply chain is a crucial task in ensuring the overall pharmaceutical supply chain. The authors outline excipient-control strategies and practices for the ...

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 ...

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 ...

Propylene glycol (PG) is a clear, odorless, and viscous liquid that is miscible with water and many organic solvents. It is a small molecule that is structurally different and unrelated to PEG, ...

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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 ...

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

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 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 ...

CLEVELAND--(BUSINESS WIRE)--Lubrizol announces that an Apisolex™ polymer excipient-enabled drug formulation is in Phase 1 clinical trials. Introduced to the market in 2022, Apisolex polymer excipient ...

Formulation development serves as a vital bridge between a drug substance and a drug product that will remain stable and ...