PEARLITOLĀ® BioPharma - Mannitol, low endotoxin, USP, EP, JP

Formulation | Excipient | Mannitol | Biopharmaceutical manufacturing

Suitable for use in biopharmaceutical manufacturing and as an excipient for injectable dosage forms.

Introduction

Biopharmaceuticals are slated to become the core of the pharmaceutical industry. These protein-based drugs have proven to be game-changing by putting rheumatoid arthritis into remission and transforming many cancers into treatable conditions.

Mannitol is used as an excipient in over 50 commercial mAbs, therapeutic proteins and vaccines.

You now have an alternative option. We can help you manage risk with a steady supply of confidence for your low endotoxin, multi-compendial grade materials from a source who has sole custody of the supply chain.

To support innovators and visionaries like you, our in-process quality control ensures a consistent supply of raw materials and excipients to help bring your biologics to life.

Monograph

PEARLITOL® BioPharma - Mannitol, low endotoxin, USP, EP, JP

® Registered trademark of Roquette Freres

Description

Appearance

  • White or almost white, crystalline powder

Solubility

  • Freely soluble in water
  • Very slightly soluble in ethanol

Compliance and regulatory

Compliance

  • EP, USP, JP

Regulatory

  • Manufacture: ICH-Q7 or IPEC PQG GMP for production and packaging
  • Distribution: IPEC Good Distribution Practices
Registrations vary depending on local regulations.
Quality attributes

biopharma quality attributes

biopharma quality attributes additionnal

Applications
Suitable for use in biopharmaceutical manufacturing and as an excipient for injectable dosage forms.
Packaging

Poly liner drums, sizes:

  • 12 kg
  • 25 kg
  • 50 kg

 

 

Product information to place an order
  • 12 kg: 450003103X  
  • 25 kg: 450003104Y 
  • 50 kg: 450003105Z
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