Clinical grade Dextran 40 is available from Pharmacosmos as Active Pharmaceutical Ingredients (API) for production of solutions for injection and infusion.
Specifications for Dextran 40
Pharmacosmos supplies Dextran 40 complying with any pharmacopoeial requirements, including:
|Dextran 40||40,000 Da||Ph. Eur.|
|Dextran 40||40,000 Da||USP|
|Dextran 40||40,000 Da||JP|
Please contact us for information about other specifications.
Documentation for Dextran 40
Pharmacosmos is the only Dextran manufacturer that has received the certificate from the European Directorate for the Quality of Medicines (EDQM) for the specific pharmacopoeial Dextran 40 clinical grade.
- European Directorate for the Quality of MedicinesPharmacosmos EDQM certificate: Dextran 40 for Injection. (Document: PDF, 2 pages, 0.51 MB)
- Danish Medicines AgencyStatement on Good Manufacturing Practices for Dextran API. (Document: PDF, 1 page, 0.41 MB)
- Dextran Powder Material Safety Data Sheet (MSDS) (Document: PDF, 4 pages, 0.14 MB)
To read the PDF-documents Adobe Acrobat Reader must be installed. Download a free version of Adobe Acrobat Reader here.
Dextran 40 Monograph
Packing and Storage of Clinical Dextrans
Clinical grade Dextrans from Pharmacosmos are packed and stored in safe and clean conditions in compliance with Good Manufacturing Practice (GMP).
Clinical grade Dextran 40 is available in the following pack sizes:
|100 g||Polyethylene container, FDA registrered, DMF type III|
|500 g||Polyethylene container, FDA registrered, DMF type III|
|5 kg||Polypropylene container. Dextran powder sealed in double polyethylene bags.|
|50 kg||Fiber drums. Dextran powder sealed in double polyethylene bags.|
Pharmacosmos supplies clinical grade Dextrans to all countries. The product packing meets all national and international regulations.
Clinical Use of Dextran 40
Both clinical grade Dextran 40 and Dextran 70 have been marketed in the US for several years. Dextran 40 and Dextran 70 intravenous solutions are approved by the US Food & Drug Administration (FDA) for plasma volume expansion in the treatment of hypovolemic shock and as a component of the pump prime for cardiopulmonary bypass.
Dextran 40 in Rheomacrodex®
Dextran 40 for injection is an Active Pharmaceutical Ingredient (API) in Rheomacrodex® used for prophylaxis of postoperative and post-traumatic thromboembolism. Rheomacrodex® may also be used as plasma volume replacement.