The quality of excipients is extremely important since 90% of medicines are made up of them. When it comes to regulatory guidelines, there are several the industry must follow to cover the Active Pharmaceutical Ingredient testing. For excipients, the most frequently used guideline is the International Pharmaceutical Excipient Council (IPEC). Excipients are well known to improve solubility and absorption, enhance disintegration, and increase stability for biologics/parenteral formulations (including injectables).

Any substance used in a pharmaceutical drug product requires manufacturing under appropriate Good Manufacturing Practices (GMP) and supplied under Good Distribution Practices (GDP). The exact definition of GMP or GDP will depend on the material in question (e.g. excipient, active pharmaceutical ingredient, and packaging) and legislation where the excipient is supplied or sold.

When you control every step of the excipient manufacturing process, you’re ensuring the excipient consistently meets required GMP compliance. The suitability of excipients for its intended use is defined by attributes such as identity, strength, and purity – which can be achieved with our instruments, consumables, and services.