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Super Refined™ pharmaceutical excipients

Super Refined™ excipients are meticulously processed using our proprietary Super Refined™ purification technology, specifically designed to reduce oxidative impurities such as peroxides, aldehydes, and catalyst residues. This advanced purification significantly reduces potential interactions between excipients and active pharmaceutical ingredients (APIs), enhancing formulation stability and drug efficacy, while minimising cellular irritation and potential allergenicity.

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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. 

FREQUENTLY ASKED QUESTIONS

Explore frequently asked questions about our Super Refined offering

Drug stability can be compromised by oxidative impurities and reactive species. Our Super Refined™ excipients undergo Croda Pharma's proprietary purification process that reduces these impurities, significantly improving formulation stability and extending shelf life.  

By employing our proprietary purification technology to reduce aldehydes, peroxides, and other impurities, Super Refined™ excipients greatly reduce the potential for cellular irritation and adverse reactions.

Super Refined™ excipients are ideal for all administration routes: injectable, ophthalmic, nasal, pulmonary, auricular, oral, topical, transdermal, vaginal and rectal formulations. Super Refined™ are particularly preferred in sensitive therapeutic areas or with unstable active pharmaceutical ingredients (APIs), thanks to our proprietary purification technology ensuring exceptionally low impurity profiles.

Super Refined™ excipients go far beyond compendial standards. They undergo Croda Pharma’s proprietary purification process to reduce oxidative impurities such as peroxides, aldehydes, and catalyst residues—components that can cause API degradation, instability, and immunogenicity. This makes Super Refined™ excipients ideal for sensitive formulations such as injectables and biologics, where ultra-purity and batch-to-batch consistency are critical.

Biologic drugs, such as monoclonal antibodies, are highly sensitive to oxidative stress. Even trace levels of impurities like peroxides can cause protein aggregation, loss of potency, or immunogenicity. Super Refined™ excipients help minimise these risks by eliminating those reactive impurities, making them ideal for biological formulations. 

Injectable formulations bypass many of the body’s natural protective barriers, such as the gastrointestinal tract and first-pass metabolism. As a result, any impurities present are introduced directly into the bloodstream or tissues, where they can cause adverse reactions, inflammation, or toxicity. Using highly purified excipients like those from our Super Refined™ range helps minimise these risks, ensuring better patient safety and enhanced drug stability in parenteral formulations.

Yes. Many of our Super Refined™ excipients include LAL bacterial endotoxin testing on their Certificates of Analysis (CoAs), supporting their use in parenteral and biologic drug formulations that require tight endotoxin control. 

Yes. By reducing oxidative impurities that can initiate degradation pathways, Super Refined™ excipients are known to enhance API stability and extend the shelf life of drug formulations. The improved stability provided by Super Refined™ excipients may also support more flexible storage conditions, potentially reducing reliance on cold-chain requirements and enabling ambient temperature storage, depending on the formulation.

Absolutely. Super Refined™ excipients often comply with multiple pharmacopeias (USP/NF, Ph. Eur., JP, ChP) and are listed in the FDA’s Inactive Ingredient Database (IID). This makes them a strong choice for global regulatory filings.

Yes. While they are especially valuable in biologics due to their high purity and low impurity profile, Super Refined™ excipients also improve the performance, stability, and sensory attributes of small molecule formulations, including oral and topical products.  

In addition to superior purity, Super Refined™ excipients come with several added benefits not typically offered with standard grades. These include: 

  • Enhanced Certificates of Analysis (CoAs) with more detailed impurity profiles, including endotoxin testing (LAL) and microbial limits for select products 
  • Nitrogen packaging for improved oxidative stability 
  • Extended pack size options, including single-use packaging 
  • Access to expertise from our technical teams to support custom requests.

These extras provide peace of mind, accelerate regulatory submissions, and ensure consistent performance from lab-scale to launch.