Polyglykol 3350 PSE
Polyglykol 3350 PSE is a sprayed PEG API grade powder product, with a mean particle size distribution.
It is produced under ICH Q7 conditions and GMP certified by the German authorities.
The powder form supports the homogeneous mixing with other powder materials within production resulting into powder mixtures with improved flowability.
It is specified according to the requirements of the main international ICH guidelines and monographs (see below).
With its low Ethylene oxide and Dioxane specification limits, special formulation requirements could be fulfilled.
Informations sur le produit
Polyglykol 3350 PSE is a sprayed PEG API grade powder product, with a mean particle size distribution.
It is produced under ICH Q7 conditions and GMP certified by the German authorities.
The powder form supports the homogeneous mixing with other powder materials within production resulting into powder mixtures with improved flowability.
It is specified according to the requirements of the main international ICH guidelines and monographs (see below).
With its low Ethylene oxide and Dioxane specification limits, special formulation requirements could be fulfilled.
- Polyethylene glycol, average molar mass 3350 g/mol
USP-NF: Polyethylene glycol 3350
Ph. Eur.: Macrogol 3350
JP.: Macrogol 4000
Powder sprayed
- Complies with monograph specifications of USP-NF "Polyethylene glycol 3350", Ph. Eur. monograph "Macrogols" and JP "Macrogol 4000"
- Manufactured according to ICH Q7 (API)
- Kosher certificate
API for laxative formulations
Germany
Certificate of Suitability (CEP) available (CEP 2002-180)
US DMF type II (DMF 013091)
