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Pharmaceutical Chemistry
PEG
Formula:
C2nH4n+2On+1
GOST/CAS:
CAS 25322-68-3
The product is a highly purified, pharmacopoeia-grade excipient designed for the manufacture of sterile dosage forms and injectable formulations. It features excellent biocompatibility, low toxicity, and high water solubility. Due to strict control of molecular weight distribution and the absence of impurities, this product ensures the stability of Active Pharmaceutical Ingredients (APIs) in solutions, regulates viscosity, and acts as a highly effective co-solvent.
Applications
Sterile Solution Manufacturing: Used as a co-solvent and stabilizer in injectable and infusible preparations (intravenous, intramuscular).
Solubility Enhancement (Solubilization): Utilized to increase the solubility of hydrophobic and poorly soluble Active Pharmaceutical Ingredients (APIs).
Lyophilized Products: Acts as a cryoprotectant and bulking agent in the production of freeze-dried injectables, preserving the structure of protein and peptide molecules.
Sustained-Release Dosage Forms: Applied in drug delivery system technologies to control and modify the release rate of the API.
Key Advantages
Pharmacopoeial Quality (Ph. Eur. / USP / JP): Manufactured in strict compliance with GMP standards, guaranteeing an ultra-pure grade of raw material suitable for parenteral administration.
High Biocompatibility: Proven safe with no immunogenic or toxic effects on the body when used within recommended dosages.
API Stabilization: Prevents protein aggregation and degradation of labile chemical compounds in liquid media, extending the shelf life of the finished dosage form.
Apyrogenicity and Sterility: Minimal endotoxin content and stringent microbiological control allow for seamless integration into aseptic manufacturing processes.
Storage & Transportation
- Store in original, tightly sealed factory packaging in a dry, dark place at temperatures between +5°C and +25°C within a cleanroom environment (Class C/D zones).
- Protect from moisture and foreign odors. Once opened, containers must be used within the shortest possible timeframe under aseptic conditions.
- Transportation is permitted via all types of covered transport in compliance with regulations for temperature-sensitive and pharmaceutical cargo. Shelf life — 2 years.
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Technical Specifications
Appearance
White powder, granules, or clear viscous liquid (depending on the grade)
Molecular Weight
Matches the nominal value (e.g., 400 / 1500 / 4000)
Purity (Assay)
Not less than 99.5%
pH (5% aqueous solution)
5.0 – 7.5
Heavy Metals
Not more than 5 ppm
Bacterial Endotoxins
< 0.1 IU/mg (for injectable grades)
Moisture Content
Not more than 0.5%
Supply info
- Multi-layer kraft bags with a double internal polyethylene liner: 10 kg / 25 kg.
- High-durability, hermetically sealed plastic jerrycans or bottles for liquid forms: 1 L / 5 L / 10 L.
- All packaging materials are certified for pharmaceutical use.