Polyethylene Glycol 400 USP–NF/Ph. Eur. PARENTEX PLUS – Solvent/Co-solvent for Enhanced Solubilization, Compliant with Injectable-Grade Standards

1. General Introduction to Polyethylene Glycol 400 (PARENTEX PLUS)

Polyethylene Glycol 400 (PEG 400) is a polymer of ethylene oxide with an average molecular weight of approximately380–420 Da. At room temperature, it is a clear, colorless, nearly odorless, slightly hygroscopic liquidwith a faintly sweet taste.

PEG 400 is a widely used pharmaceutical excipient due to its excellent ability to solubilize poorly water-soluble active pharmaceutical ingredients (APIs). It is commonly employed as a solvent and co-solvent to enhance API solubility in liquid and semi-solid dosage forms.

Polyethylene Glycol 400 (PARENTEX PLUS) is a premium PEG 400 grade manufactured to meet the stringent quality requirements for parenteral pharmaceutical applications in accordance with the USP–NF and Ph. Eur. standards. It is produced under rigorous quality control with tight specifications for purity, process-related impurities, microbiological quality, and bacterial endotoxins, making it suitable for use in injectable formulations.

2. PEG 400 PARENTEX PLUS Material Information

• Material Name: Polyethylene glycol 400 (PEG 400 / Macrogol 400) - Brand: PARENTEX PLUS
• Origin: India
• Material Category: Pharmaceutical Excipients.
• Main Functions: Solvent and Co-solvent for Solubility Enhancement
• Physical Form:Clear, slightly viscous, colorless liquid with mild hygroscopic properties.
• Solubility: Very soluble in water, alcohol (ethanol), acetone, and other glycols; insoluble in ether and fatty oils.
• Quality Standards: Meets United States Pharmacopeia (USP-NF) and European Pharmacopoeia (Ph.Eur) standards.

The material is strictly controlled for:

• Bacterial endotoxin specification:Complies with the stringent requirements for use in parenteral (injectable) formulations.
• Total Aerobic Microbial Count (TAMC) and Total Yeast & Mold Count (TYMC):Maintained within the stringent microbiological limits required for pharmaceutical applications, including injectable formulations.
• Specified pathogenic microorganisms:Free from objectionable microorganisms, including Escherichia coli (E. coli), Pseudomonas aeruginosa, Staphylococcus aureus, Enterobacteriaceae, and other bile-tolerant Gram-negative bacteria.
• Toxic impurity control:Ethylene Glycol (EG) and Diethylene Glycol (DEG) are tightly controlled at extremely low levels to ensure maximum patient safety.
• Peroxide and aldehyde levels: Maintained at minimal levels to reduce the risk of oxidative degradation of oxidation-sensitive active pharmaceutical ingredients (APIs), thereby enhancing formulation stability.

3. Key advantages of PEG 400 PARENTEX PLUS

• Dedicated grade for injectable applications: Manufactured specifically for parenteral pharmaceutical use, with stringent quality controls to meet the rigorous requirements for injectable formulations.
• Excellent solubilizing performance: PEG 400 is a widely used solvent and co-solvent capable of dissolving a broad range of poorly water-soluble active pharmaceutical ingredients (APIs). It helps minimize API recrystallization, thereby improving dissolution, enhancing drug absorption, and increasing bioavailability.
• Low viscosity: Its low viscosity facilitates processing, handling, and manufacturing operations during pharmaceutical formulation.
• Excellent biocompatibility and compatibility: PEG 400 exhibits very low toxicity and is generally well tolerated in oral, topical, and selected parenteral formulations. It is compatible with a wide variety of APIs and pharmaceutical excipients, providing high formulation flexibility.
• International-quality standard: Manufactured in a GMP-compliant facility under stringent quality control to ensure consistent purity and quality, meeting the requirements of global pharmaceutical manufacturing standards.

4. Applications of PEG 400 PARENTEX PLUS

In Pharmaceuticals:

• Injectable formulations: Used as a co-solvent to enhance API solubility, improve dispersion, and stabilize the formulation.
• Ophthalmic and nasal formulations
• Oral liquid dosage forms

In Health Supplements:

• Oral liquid dosage forms:Used as a co-solvent to enhance API solubility, improve dispersion, and stabilize the formulation.

5. Commercial Products Using PEG 400

6. Product Contact Information

For more information regarding the supply chain, technical specifications of Polyethylene Glycol 400 PARENTEX PLUS, or to place an order, please contact us:

• Consultation Hotline: +84 (0) 834 560 500
• Email: director@biorichgroup.com
• Website:www.biorichgroup.com
• Sample/COA Request: Please contact us via email to request testing samples and the latest Certificate of Analysis (COA) for the material from the manufacturer.