POLYETHYLENE GLYCOL, AVERAGE MOLAR MASS 3350 G/MOL
VitiPure™ LEX 3350 S
改訂日 :
2026年2月18日
VitiPure™ LEX 3350 is a medium molecular weight polyethylene glycol excipient type of the VitiPure™ LEX range for sensitive APIs and formulations. With defined microbiological and endotoxin checks of the final packed product batch, which are given individually on the certificate of analysis, we would like to support you in your individual formulation risk assessment.
Product Information
ベネフィット
- Low endotoxin & microbial load for sensitive applications
- Includes microbiology specification for
- Endotoxin: max. 1 IU/g
- TAMC: max. 50 cfu/g
- TYMC: max. 50 cfu/g
- Salmonella: absent
- Staphylococcus aureus: absent
- Escherichia coli: absent
- Pseudomonas aeruginosa: absent
- Surpass the current international pharmacopoeia requirements
Product details
Chemical Name
- Polyethylene glycol, average molar mass 3350 g/mol
製品機能
- Solvent
Flakes
USP-NF: Polyethylene glycol 3350
Ph.Eur.: Macrogol 3350
JP: Macrogol 4000
- Complies with monograph specifications of USP-NF "Polyethylene glycol 3350", Ph. Eur. monograph "Macrogols" and JP "Macrogol 4000"
- Manufactured according to IPEC-GMP (Excipients)
- Low Endotoxin grade suitable for sensitive formulations
- Control of TAMC, TYMC, objectionable bacteria
- Control of elemental impurities as per ICH Q3D required for parenteral applications limits
- Kosher certificate
Germany
Registered in China as excipient for injection use (F20240000562)
Documentation
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