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    Excipients for Drug Formulation Excipients for Parenteral Use

    Excipients for Parenteral Use

      The parenteral application requires excipients of highest quality standards. Solubilizers and co-solvents are the most widely employed excipients in the formulation of parenterals. BASF offers a wide range of high-quality solubilization excipients and has unparalleled experience in quality and regulatory affairs, as well as solubility enhancement strategies.

      We offer a range of highly effective solubilization excipients for parenterals. Our experts have access to industry-leading tools and analytics such as our in-house developed high throughput formulation robot, comprehensive solubilization screening, supersaturation and crystallization precipitation kinetics, as well as biorelevant analysis. Coupled with a deepand profound understanding of our excipients, we are in anexcellent position to enable our customers to tackle their solubilization challenges rapidly and efficiently.

      Our excipients for parenterals are produced in Germany by qualified and experienced employees in line with the appropriate high-quality standards including documentation, equipment, utilities and personnel.

    The quality & regulatory benchmark BASF applies to its excipients for parenterals comprises 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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