BASF High Purity Excipients for Parenteral Pharmaceutical Formulations
BASF Parenteral Excipients for Pharmaceutical Formulations
BASF offers high-purity excipients for your parenteral formulations, with a range of chemistries suitable for solubilizing challenging APIs. We support your injectable formulation development with our compendium-approved excipients for parenteral administration, and are committed to providing high quality products supported by best-in-class Regulatory, Quality, and Technical teams.
Our excipients for parenterals are produced in Germany by qualified and experienced employees in line with high-quality standards including documentation, equipment, utilities and personnel.
|Product||Chemistry||Functionality||Compendial Compliance||FDA IID Listing|
|Kolliphor® HS 15||Macrogol 15 Hydroxystearate; Polyoxyl 15 Hydroxystearate; Polyethoxylated 12-hydroxystearic acid||Nonionic solubilizer and emulsifier (surfactant; HLB = 15)||Ph.Eur.; USP/NF||yes|
|Kolliphor® ELP||Macrogolglycerol Ricinoleate; Polyoxyl 35 Castor Oil; Polyethoxylated Castor Oil||Nonionic solubilizer and emulsifier (surfactant; HLB = 12–14)||Ph.Eur.; USP/NF||yes|
|Kollidon® 12 PF||Povidone||Solubilizer by complexation||Ph.Eur.; USP/NF; JP||yes|
|Kollidon® 17 PF||Povidone||Solubilizer by complexation||Ph.Eur.; USP/NF; JP||yes|
Quality & Regulatory
The quality and regulatory benchmarks BASF applies to its parenteral excipients are comprised of:
Manufacturing according to IPEC-PQG GMP
- Compendial compliance covering current and proposed major global pharmacopoeia standards
- Endotoxin & microbial testing
- Elemental impurity limits as per ICH Q3D
- Stability studies as per ICH guidelines
- Regulatory documentation
- Registration & submission support
- Non-clinical safety data
Synonyms: parenteral excipients, injectable excipients, intraveneous, ophthalmic, auricular, nasal, otic
Kolliphor® and Kollidon® are registered trademarks of BASF SE.