Today’s parenteral formulations industry is growing rapidly. In the vaccines segment, for instance, government organizations are launching increasing numbers of programs around the world to combat the rising prevalence of (infectious) diseases. In fact, demand for excipients as safe carriers in vaccines and other injectables is higher than ever before (Kaddar, 2013). Trends like this are pushing up demand for excipients offering patients maximum safety. As gelatin is widely used as stabilizing excipient, Rousselot Biomedical’s X-Pure range significantly increases patient safety.
X-Pure® 10 HGP: safer than ever
Our excipient for parenteral formulations, X-Pure® 10 HGP (a hydrolyzed gelatin of porcine origin), is one of the purest acid gelatin alternatives available on today’s market. Purified by means of a validated process, it also offers the benefit of consistent quality.
- Unrivalled safety as the first hydrolyzed acid porcine gelatin on the market with endotoxin levels below 10 Endotoxin Units per gram (EU/g), or even below LAL analysis detection limits if required
- Biodegradable, and therefore absorbable
- A substance of natural origin, well tolerated by the human body and biocompatible
- Purified by Rousselot, following a validated process
- Maximum quality consistency
- Generally Recognized As Safe (GRAS) by the USA’s Food and Drug Administration (FDA) and compliant with the US, and European pharmacopeia
- Suitable for both human and veterinary applications
Find out more our validation method under Quality first