The debate over functionality is not about to be settled anytime soon. Raw materials are one of the main sources of batch-to-batch variation. Although analytical tests evaluate whether a material is ...

This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment. The forthcoming American National Standard ...

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, ...

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 ...

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 ...

WILMINGTON, Del., Oct. 31, 2022 (GLOBE NEWSWIRE) -- Ashland Inc. (NYSE: ASH) today announced the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research Office of New ...

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 US Food and Drug Administration (FDA) has launched a new pilot program to review novel excipients for use in meeting unmet needs in formulating new drug products. The pilot has the full support of ...

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 ...

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