LYCADEX® PF

LYCADEX® PF
Nature’s sweet medicine

Dextrose or glucose is the physiological sugar used as an active isotonic agent or a carbohydrate energy source in parenteral infusion or injectable therapies. It is also an essential ingredient in the formulation of peritoneal dialysis and haemodialysis solutions.
These mass medication products can be lifesaving and their quality is critical. The dextrose solutions used in these therapies have to be of the very highest quality.

With LYCADEX® PF, Roquette has pioneered the development of this level of quality in a pyrogen-free Dextrose Monohydrate product that has set a standard recognised around the world.

DESCRIPTION D-Glucose monohydrate for injectable solutions. White, odourless, sweet tasting  crystalline powder, freely soluble in water.    COMPLIANCE Pharmacopoeia conformity - European Pharmacopoeia - USP / NF GMP - Manufacturing plant compliant with cGMP/FDA and GMP/ICH Q7A quality guidelines   REGULATORY DOCUMENTATION CEP: R2CEP1996-030 US DMF type II n° 4697 (Lestrem plant) US DMF type II n° 11059 (Keokuk plant) A CTD-format document with LYCADEX® PF information can be obtained under confidentiality agreement.

PROPERTIES Double control: Assay for endotoxins (L.A.L. test) Detection of pyrogenic substances (rabbit test)  High filterability: The high filterability of  LYCADEX® PF extends the lifetime of filters and saves extra production costs caused by clogging    APPLICATIONS Osmotic agent in injectable solutions and dialysis solutions Energy source for parenteral nutrition Treatment of hypoglycaemia

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:

• 50 kg pinch bottom bag
• 25 kg pinch bottom bag
• big bag up to 1000 kg

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
- LYCADEX® PF pyrogen-free dextrose monohydrate - 4 pages + technical bulletins
- A reliable pyrogen-free range for life-saving injectables - 40 pages

- A CTD-format document with LYCADEX^®PF information can be obtained under confidentiality agreement.

 

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