Key highlights of super refined™ pharmaceutical excipients
Super Refined™ is our highest purity offering, enabled by Super Refined™ purification with:
- Excellent batch-to-batch consistency
- Additional Certificate of Analysis (CoA) testing beyond monograph requirements for many products
- Enhanced packaging under nitrogen for improved oxidative stability
- Improved API stability, extending formulation shelf life
- Reduced risk of cellular irritation and allergenic reactions, supporting better patient safety and tolerability
- Compliance with major global pharmacopeias (USP/NF, Ph. Eur., JP/JPE, ChP).
The role of Super Refined™ excipients in drug formulation
Selecting the right excipient is critical. Excipient compatibility with both your drug and your formulation can mean the difference between a failed drug and commercial success. Croda Pharma’s Super Refined™ excipients, produced via our proprietary purification process, support drug formulators by ensuring consistent purity and performance across a broad range of excipient chemistries including:
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We pride ourselves on working with our customers to develop the solutions they need for market success. Our team of technical experts can leverage our proprietary purification methods to develop customised Super Refined™ excipient solutions tailored specifically to your drug formulation requirements. Click here to speak to an expert.
Benefits of formulating with Super Refined™ excipients
Super Refined™ excipients, produced using our proprietary purification technology, offer several critical advantages to drug developers:
- Formulation stability: Super Refined™ purification significantly reduces API degradation
- Batch-to-batch consistency: Ensures repeatable, reproducible quality across every batch, supporting seamless scale-up from development through to commercialisation
- Enhanced patient safety: Minimizes risk of irritation, allergic reactions, and toxic impurities through advanced impurity removal
- Improved patient compliance: Reduces impurities to give excipients that lower in colour, taste and odour, enhancing patient compliance
- Regulatory advantages: Stringent impurity control facilitates smoother regulatory submissions, accelerates FDA approvals, and reduces time to market
- Additional CoA testing: Certificates of Analysis (CoA) comes with detailed impurity profiling uniquely available for select Super Refined™ excipients, ensuring confidence in quality and compliance.