POLYETHYLENE GLYCOL, AVERAGE MOLAR MASS 4000 G/MOL
VitiPure LEX 4000 S
Edition Date :
July 02, 2024
VitiPure LEX 4000 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
Benefits
- 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
Product Function
- Solvent
Physical appearance
Flakes
Pharmacopoeia Name
USP-NF: Polyethylene glycol 4000, Ph. Eur.: Macrogol 4000
Quality status
- 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
Application function
Solvent, Viscosity Enhancer
Origin
Germany
Documentation
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