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.

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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

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Synonyms: parenteral excipients, injectable excipients, intraveneous, ophthalmic, auricular, nasal, otic

Kolliphor® and Kollidon® are registered trademarks of BASF SE.