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VitiPure LEX 400

Polyethylene Glycol 400

Edition Date :
July 07, 2022

VitiPure LEX 400 are low molecular weight polyethylene glycols with stringent control of microbial load & low in endotoxins for pharmaceutical high-risk formulations. They are colorless and tasteless liquid at room temperature. They are readily soluble in common solvents such as water, ethanol, acetone, glycols etc.

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
  • Supports risk assessment in pharmaceutical and biopharmaceutical manufacturing
Chemical Name
  • Polyethylene Glycol 400
Product Function
  • Solvent
  • Humectant

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Applications

VitiPure LEX 400 are excellent solvents and solubilizing agents for active substances and excipients in liquid preparation

Generic Name

Macrogol (Ph. Eur., JP),  Polyethylene glycol (USP/NF)

Grade

IPEC GMP Pharma Grade

Country of Origin

Germany

Manufacturer address

Clariant Produkte (Deutschland) GmbH, Industrieparkstrasse 1, D-84508 Burgkirchen, Germany

Packaging size (Article Nr.)

220kg steel drum (32221310564) and 30kg steel drum (32221317072); Sample size 0.5kg

Retest period

24 months