Polyethylene Glycol
VitiPure LEX 400
Edition Date :
April 19, 2024
VitiPure LEX 400 is a low 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 high-risk applications
- Includes the microbiology specifications: Endotoxin: max. 1 IU/ml; TAMC: max. 50 cfu/g TYMC: max. 50 cuf/g; Salmonella: absent; Staphylococcus aureus: absent; Escherichia coli: absent; Pseudomonas aeruginosa: absent
- Surpass the current pharmacopoeia requirements
Product details
Chemical Name
- Polyethylene Glycol
Product Function
- Solvent
- Humectant
Solvent, Viscosity Enhancer
USP-NF: Polyethylene glycol 400, Ph. Eur.: Macrogol 400, J.P.: Macrogol 400
- 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
Documentation
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