PEG 400 (Polyethylene Glycol 400) Pharmaceutical Supplier in India: Complete Guide

06-08-2026

PEG 400, or polyethylene glycol 400, is a low molecular weight, liquid grade polyethylene glycol used across the pharmaceutical industry as a solvent, co-solvent, and carrier for poorly water soluble drugs in oral, topical, and parenteral formulations. With an average molecular weight of approximately 400 g/mol, it sits at the liquid end of the PEG family, distinct from the waxy, solid grades like PEG 4000 or PEG 6000 used mainly in tablet coatings. For Indian pharmaceutical manufacturers, sourcing pharmaceutical grade PEG 400 from a supplier who can meet pharmacopoeial purity limits is a routine but important procurement decision that directly affects formulation safety and regulatory compliance.

What Is PEG 400?

PEG 400 is a polyether compound formed by the polymerization of ethylene oxide, with the general structure H-(O-CH2-CH2)n-OH. Because it is produced as a mixture of chain lengths rather than a single defined molecule, the number 400 refers to the average molecular weight of the polymer distribution, not a single fixed mass. At room temperature, PEG 400 exists as a clear, colorless to pale yellow, viscous liquid that is miscible with water, alcohols, and many organic solvents, which is precisely why it is so valuable as a pharmaceutical solvent.

Why PEG 400 Is Used in Pharmaceutical Formulations

Solubilizing poorly water soluble drugs

PEG 400 is one of the most widely used co-solvents for improving the solubility of active pharmaceutical ingredients that do not dissolve well in water alone, a common challenge across oral liquids, soft gel capsules, and injectable formulations.

Carrier in oral, topical, and parenteral products

It functions as a base or carrier for oral solutions and suspensions, as a component in ointment and cream bases, and, at appropriately controlled purity, as a solvent system in select parenteral formulations.

Suppository and semisolid bases

PEG 400 is commonly blended with higher molecular weight PEGs to create suppository bases with a specific melting point and dissolution behavior.

Ophthalmic formulations

Certain low endotoxin grades of PEG 400 are used in ophthalmic solutions, including artificial tears, where it helps adjust viscosity and improve lubrication while remaining biocompatible and non-irritating to ocular tissue.

Humectant and viscosity modifier

In topical and cosmetic-adjacent pharmaceutical products, PEG 400 also acts as a humectant, helping formulations retain moisture and maintain a smooth, spreadable consistency.

Key Quality Parameters and Pharmacopoeial Limits

Because PEG is manufactured through the polymerization of ethylene oxide, trace levels of certain process related impurities must be tightly controlled for pharmaceutical use. Formulators sourcing PEG 400 in India should confirm the following, ideally against USP-NF, BP, or Ph. Eur. monograph limits:

Ethylene glycol content, typically required to stay at or below very low ppm levels, since ethylene glycol is toxic even in small quantities. A commonly cited limit for high grade pharmaceutical PEG 400 is not more than 30 ppm.
Diethylene glycol content, another closely monitored impurity, often required to stay below roughly 300 ppm in stringent pharmaceutical grade material.
Heavy metals, particularly lead, which regulated suppliers control down to fractions of a ppm, commonly cited around 0.05 ppm or lower for the most stringent applications.
Hydroxyl number, which correlates with average molecular weight and helps confirm the material is genuinely within the PEG 400 range rather than a mislabeled adjacent grade.
Appearance and clarity, since a clear, colorless to pale yellow liquid is the expected visual specification.
Microbial limits and endotoxin data, essential for any parenteral or ophthalmic grade material.

These are not optional checks. Ethylene glycol and diethylene glycol contamination in PEG based excipients has been linked to serious safety incidents globally in pharmaceutical products, which is why regulatory scrutiny on these specific impurities has intensified across major markets, including India.

PEG 400 vs Higher Molecular Weight PEG Grades

A frequent point of confusion for formulators new to PEG sourcing is understanding when to use PEG 400 versus higher molecular weight grades like PEG 4000 or PEG 6000.

PEG 400 is a liquid at room temperature, highly hygroscopic, and primarily used as a solvent, co-solvent, or carrier in liquid, semisolid, and select parenteral formulations.
PEG 4000 and above are solid, waxy powders or flakes at room temperature, far less hygroscopic, and primarily used in solid dosage forms as binders, lubricants, and tablet film coating components.
The choice between grades depends entirely on the dosage form and the physical state required. Some formulations, particularly suppositories and certain semisolid systems, deliberately blend a liquid grade like PEG 400 with a solid grade to fine tune melting point and consistency.

Regulatory Standing and Compendial Status

PEG 400 is recognized under USP-NF, BP, and Ph. Eur. monographs as a pharmaceutical excipient, and is generally regarded as safe with reported systemic absorption below roughly 0.5 percent following oral administration, reflecting its low toxicity profile at the doses typically used in formulations. Because it is used across such a wide range of dosage forms including injectables, formulators should always confirm the specific grade and its documented compliance with the intended administration route before finalizing a formulation.

Sourcing PEG 400 in India

India has a well developed domestic supply base for pharmaceutical grade PEG 400, ranging from established ISO certified and WHO-GMP certified manufacturers offering the full PEG range from PEG 200 through PEG 20000, to regional exporters and specialty excipient distributors. Pricing for PEG 400 in India typically sits in the range of several hundred rupees per kilogram for standard pharmaceutical grade material, though pricing varies by purity grade, pack size, and order volume, and buyers should always request current quotations rather than relying on indicative pricing.

When evaluating suppliers, prioritize those who can provide full documentation against your target pharmacopoeial monograph, low endotoxin grade options if your application requires them, and consistent batch to batch quality, since PEG 400's role as a solvent means any variability directly affects the finished formulation's solubility and stability behavior.

Sourcing PEG 400 Through Clyzo

Formulators in India looking for a dependable, well documented source of pharmaceutical grade PEG 400 can explore Clyzo, a digital procurement platform for pharmaceutical excipients and raw materials based in Thane, Maharashtra. Clyzo's online catalog allows formulators to search across PEG grades, review technical documentation and compendial compliance details, request samples, and generate quotations without relying purely on the slower, relationship driven processes that have traditionally defined excipient sourcing in India.

Frequently Asked Questions

1. What is PEG 400 used for in pharmaceuticals?

PEG 400 is used as a solvent and carrier to improve the solubility of poorly water soluble drugs in oral, topical, and select parenteral and ophthalmic formulations, and as a component in ointment, cream, and suppository bases.

2. What does the number 400 in PEG 400 mean?

The number 400 refers to the average molecular weight, in Daltons, of the polyethylene glycol polymer distribution, not a single fixed molecular weight.

3. Is PEG 400 safe for use in pharmaceutical products?

Yes, PEG 400 is recognized as safe under major pharmacopoeial monographs when manufactured to pharmaceutical grade purity, with reported systemic absorption below roughly 0.5 percent after oral administration.

4. Why are ethylene glycol and diethylene glycol limits important in PEG 400?

Ethylene glycol and diethylene glycol are toxic process related impurities that can form during PEG manufacturing, and pharmaceutical grade material must keep these well below strict pharmacopoeial limits, commonly cited around 30 ppm and 300 ppm respectively for high grade material, to ensure patient safety.

5. What is the difference between PEG 400 and PEG 4000?

PEG 400 is a liquid at room temperature and used mainly as a solvent or carrier, while PEG 4000 is a solid, waxy powder used mainly as a binder, lubricant, or film coating component in solid dosage forms like tablets.

6. Can PEG 400 be used in injectable formulations?

Yes, appropriately purified, low endotoxin grades of PEG 400 are used as a co-solvent in some parenteral formulations, though the specific grade must be confirmed as suitable for the intended route of administration.

7. Is PEG 400 used in ophthalmic products?

Yes, low endotoxin grades of PEG 400 are used in ophthalmic solutions such as artificial tears, where it helps adjust viscosity and improve lubrication while remaining non-irritating to the eye.

8. What documentation should I request from a PEG 400 supplier in India?

Request a certificate of analysis confirming compliance with the relevant USP-NF, BP, or Ph. Eur. monograph, along with specific data on ethylene glycol, diethylene glycol, and heavy metal content, plus a technical data sheet and safety data sheet.

9. Where can I source pharmaceutical grade PEG 400 in India?

PEG 400 can be sourced from established Indian PEG manufacturers offering the full pharmaceutical grade range, regional exporters, and digital procurement platforms such as Clyzo, which allow formulators to compare documentation and request samples online.

Final Thoughts

PEG 400 remains one of the most widely used solvent excipients in pharmaceutical formulation precisely because of its versatility across oral, topical, ophthalmic, and select parenteral products. For Indian manufacturers, the sourcing decision comes down to verifying pharmacopoeial compliance, particularly around ethylene glycol and diethylene glycol impurity limits, and working with a supplier who can consistently deliver documented, batch reproducible material for the specific route of administration involved.

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