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High Purity (HP) pharmaceutical excipients

Croda Pharma’s excipient offerings span a range of purities to support diverse drug formulation needs.
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About our High Purity (HP) excipients

While standard compendial grades may suffice for some applications, High Purity (HP) excipients offer enhanced oxidative stability, consistent quality, and tight impurity control—making them ideal for: 

  • Sensitive oral and topical drug formulations 
  • Select injectable and biologic systems 
  • Applications where performance and purity matter—but ultra-purification isn’t essential.

All HP excipients are packaged under nitrogen to preserve stability and protect against oxidative degradation, ensuring batch-to-batch reliability and extended shelf life. 

Why choose High Purity (HP) excipients?

Not all excipients are created equal. Croda Pharma’s High Purity (HP) range provides: 

  • Enhanced purity: Special manufacturing controls and tighter impurity profiles than baseline pharmacopeial requirements for most HP products 
  • Oxidative stability: Nitrogen packaging for excipient integrity and extended shelf life 
  • Consistency: Reliable batch-to-batch reproducibility for smooth scale-up and manufacturing 
  • Global compliance: Multicompendial compliance across one or more pharmacopeial monographs   
  • Regulatory confidence: Recognized throughout the industry for consistent quality and performance. 

While Super Refined™ excipients remain our premium choice for ultra-sensitive applications, our Tween™ HP excipients are widely adopted in biologics—from stabilising proteins and mAbs to delivering small molecules with consistent performance. 

We trust our customers to choose the grade that works best for their drug substance, providing you with two purity levels based on your formulation goals. 

Croda Pharma: The inventors of Tween™  

With our Tween™ brand supported by decades of legacy use and industry recognition, Croda Pharma offers several Tween™ HP excipients that are suitable options in biologic formulations. 

Tween™ HP range:

Innovation in High Purity (HP) pharmaceutical excipients

Croda Pharma’s continued innovation in the HP range is exemplified by Tween™ 20 HP LSA - specially optimised for use in monoclonal antibody (mAb) formulations. Developed in response to evolving biologics needs, Tween™ 20 HP LSA offers: 

  • Controlled impurity profile 
  • Enhanced protein stabilisation 
  • Exceptional batch-to-batch consistency.  

FREQUENTLY ASKED QUESTIONS

Explore frequently asked questions about our High Purity (HP) offering