PEARLITOL® PF

• Pyrogen free mannitol is used as an osmotic diuretic in the manufacture of Intravenous fluids. Osmotic diuretics act in the kidney to cause excess body water to be removed from the blood.
  
  
• Mannitol pyrogen free is also used to reduce elevated pressure in the brain (cerebral oedema) and in the eyes. In these critical solutions, mannitol acts as a pharmaceutical active ingredient and its production has to comply with the internationally accepted GMP standards.

DESCRIPTION White, odourless, slightly sweet tasting, crystalline powder.   COMPLIANCE Pharmacopoeia conformity - European Pharmacopoeia - USP / NF - Japanese Pharmacopoeia  GMP - Manufacturing plant compliant with cGMP/FDA and GMP/ICH Q7A quality guidelines REGULATORY DOCUMENTATION US DMF Type II n° 12 879 CEP: R1CEP200-039

PROPERTIES Physical and chemical Very low hygroscopicity Excellent chemical stability Water solubility at 20°C = 17g / 100ml Dietetic* Sugarless (non-cariogenic) May be advised for diabetics Low-calorie  APPLICATIONS Diuretic-osmotic for injectable solutions   * Refer to local legislation

TYPICAL FORMULATION

At present there are no typical formulations available in our database for this product.

However Roquette has long offered an integrated customer service for formulation assistance (see here presentation of Applications Laboratory Services & Support).

Roquette continuously develops new formulations to serve as basic guidelines for optimum performance of its products. To know more about our typical formulations, please contact us or fill in our Formulation Assistance Request.

 

 

CURRENT PACKAGING FOR THIS FAMILY OF PRODUCTS

To check the immediate availability of these packaging formats or other special packaging, please contact us or  your local Roquette representative for  further information.

 

QUALITY-RELATED DOCUMENTATION

• Group quality policy
• Group safety policy
• Group environmental policy / S.M.E.
• ISO certificate
• GMO certificate

TECHNICAL BROCHURES

• PEARLITOL® 200 SD – The ultimate mannitol for DC tablets – 20 pages
• PEARLITOL® mannitol for pharmaceutical applications - 20 pages
• A reliable pyrogen-free range for life-saving injectables - 40 pages

 

 

SAMPLE REQUEST

Early formulation is important and we recognize the need for formulators to have representative material for initial testing. We can provide small non-commercial samples wherever you are in the world, with both the corresponding certificate of analysis and conformity and the material safety data sheet.

To obtain access to this service, please log in with your personal password and submit your sample or other request here.

Sample request form