Clinical grade Dextran 70 is available from Pharmacosmos as Active Pharmaceutical Ingredients (API) for production of solutions for injection and infusion.
Specifications for Dextran 70
Pharmacosmos supplies Dextran 70 complying with any pharmacopoeial requirements, including:
|Dextran 70||70,000 Da||Ph. Eur.|
|Dextran 70||70,000 Da||USP|
|Dextran 70||70,000 Da||JP|
Please contact us for information about other specifications.
Documentation for Dextran 70
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 70 clinical grade.
- European Directorate for the Quality of MedicinesPharmacosmos EDQM certificate: Dextran 70 for Injection. (Document: PDF, 2 pages, 0.46 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 70 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 70 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 70
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 70 in RescueFlow®
Dextran 70 for injection is an Active Pharmaceutical Ingredient (API) in RescueFlow® marketed by BioPhausia AB. RescueFlow® is currently approved in 14 European countries for use as the initial treatment of hypovolemia with hypotension induced by traumatic injury.
Dextran 70 in Tears Naturale®
Dextran 70 is an active ingredient in Tears Naturale®, which is used by patients generating insufficient amounts of tears. Dextran 70 and hypromellose combined has a lubricating effect on the eyes similar to natural tears.
Other Therapeutic Indications for Dextran 70
Intravenous solutions of Dextran 70 are also approved for postoperative thromboembolic prophylaxis, and studies have shown that clinical grade Dextran 70 significantly reduces the risk of post-operative fatal pulmonary emboli (1,2).
- Bergentz S.E., World J. Surgery 2, 19 (1976)
- Bergquist D., et al., Acta Orthop. Scand. 55, 247 (1984)