POLYETHYLENE GLYCOL, AVERAGE MOLAR MASS 4000 G/MOL
VitiPure™ LEX 4000 S
Edition Date :
February 18, 2026
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, average molecular mass 4000 g/mol
Product Function
- Solvent
Flakes
USP-NF: Polyethylene glycol 4000
Ph. Eur.: Macrogol 4000
- Complies with monograph specifications of USP-NF "Polyethylene glycol 3350" and Ph. Eur. monograph "Macrogols".
- 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 (F20250000069)
Documentation
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