06-08-2026
PEG 4000, or polyethylene glycol 4000, is a solid, waxy grade of polyethylene glycol widely used in pharmaceutical manufacturing as a binder, lubricant, plasticizer, and film-forming agent, particularly in tablet coating and solid dosage form production. Unlike liquid grades such as PEG 400, PEG 4000 exists as a white to off-white flake or powder at room temperature, and its higher molecular weight gives it very different functional properties suited to solid, rather than liquid, formulations. For pharmaceutical manufacturers in India producing tablets, capsules, and suppositories, sourcing consistent, pharmacopoeial grade PEG 4000 is an important part of ensuring reliable manufacturing performance and finished product stability.
PEG 4000 is identified by CAS number 25322-68-3, the same registry number shared broadly across the polyethylene glycol family since PEGs are classified by average molecular weight rather than a single discrete structure. Typical pharmaceutical grade PEG 4000 has an average molecular weight in the range of roughly 3,100 to 4,010 g/mol and a hydroxyl number generally between 28 and 36 mg KOH per gram, both of which are used to confirm the material genuinely falls within the PEG 4000 classification. A 5 percent aqueous solution of pharmaceutical grade PEG 4000 should appear clear and colorless, which is one of the simplest visual quality checks formulators can request from a supplier.
Because it is a much higher molecular weight polymer than PEG 400, PEG 4000 is significantly less hygroscopic, meaning it absorbs far less moisture from the surrounding air. This property makes it especially valuable for solid dosage forms where moisture uptake can compromise the stability of moisture-sensitive active ingredients.
Tablet film coating
PEG 4000 is a well established component of tablet film coating formulations, contributing to the formation of smooth, durable, and often glossy coatings that improve the visual finish and swallowability of oral solid dosage forms.
Binder for tablet integrity
As a meltable binder, PEG 4000 helps tablets maintain their shape, hardness, and structural integrity during and after compression, contributing directly to the mechanical robustness of the finished tablet.
Lubricant for compression and ejection
PEG 4000 reduces friction during the tablet compression process, helping prevent sticking to dies and punches and supporting smoother, more efficient tablet ejection during high speed manufacturing runs.
Plasticizer in coating systems
In film coating formulations, PEG 4000 can act as a plasticizer, improving the flexibility and mechanical resilience of the coating film so it does not crack or become brittle over the product's shelf life.
Suppository and semisolid base
PEG 4000 is frequently blended with other PEG grades, including liquid grades like PEG 400, to formulate suppository bases with a precisely tuned melting point suited to the intended administration temperature.
Modifying drug release profiles
In solid dosage forms, PEG 4000 can influence the dissolution rate of active pharmaceutical ingredients, and it has also been used in specialized applications such as osmotic pump tablet systems where controlled, prolonged drug release is the formulation goal.
Formulators often weigh PEG 4000 against the next grade up, PEG 6000, when selecting a solid PEG excipient.
Because both PEG 400 and PEG 4000 are extremely common in pharmaceutical formulation but serve very different purposes, it helps to be explicit about when each is the right choice.
PEG 4000 is recognized as an inactive ingredient across major pharmacopoeial monographs, generally regarded as safe with low reported toxicity at the concentrations used in pharmaceutical formulations. Beyond pharmaceuticals, PEG 4000 also finds use in cosmetic formulations as a humectant and emollient, and across industrial sectors including textiles, paints, and detergents, where it functions as a lubricant, dispersant, or anti-foaming agent, reflecting the same versatility that makes it valuable in drug manufacturing.
India has an established domestic manufacturing base for solid PEG grades, with several ISO certified and WHO-GMP compliant producers offering PEG across the full range from low molecular weight liquid grades through PEG 20000. Pricing for pharmaceutical grade PEG 4000 varies by purity, pack size, and order volume, and buyers should always request current, batch specific quotations along with full documentation rather than relying on generic price listings.
When evaluating suppliers, look closely at whether they can provide consistent hydroxyl number and molecular weight data across batches, since variability here directly affects coating quality, tablet hardness, and dissolution behavior in the finished product.
Formulators in India looking for a dependable, well documented source of pharmaceutical grade PEG 4000 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 from liquid through solid molecular weights, review technical documentation and compendial compliance details, request samples, and generate quotations directly online, simplifying a sourcing process that has traditionally relied on slower, relationship driven procurement.
1. What is PEG 4000 used for in pharmaceuticals?
PEG 4000 is used mainly as a binder, lubricant, plasticizer, and film-forming agent in tablet coatings and solid dosage forms, and as a component in suppository bases.
2. What is the molecular weight of PEG 4000?
Pharmaceutical grade PEG 4000 typically has an average molecular weight in the range of approximately 3,100 to 4,010 g/mol, with the number 4000 referring to this average rather than a single fixed molecular weight.
3. Is PEG 4000 a liquid or a solid?
PEG 4000 is a solid at room temperature, typically appearing as white to off-white flakes or powder, unlike lower molecular weight grades such as PEG 400, which are liquids.
4. What is the difference between PEG 4000 and PEG 400?
PEG 400 is a liquid used mainly as a solvent or carrier for poorly soluble drugs, while PEG 4000 is a solid used mainly as a binder, lubricant, and tablet coating component, reflecting their very different molecular weights and physical properties.
5. Why is PEG 4000 used in tablet coatings?
PEG 4000 contributes to smooth, durable film coatings and can act as a plasticizer that keeps the coating flexible, helping prevent cracking and improving the tablet's overall appearance and mechanical robustness.
6. Is PEG 4000 safe for pharmaceutical use?
Yes, PEG 4000 is recognized as safe under major pharmacopoeial monographs when manufactured to pharmaceutical grade purity, with a long history of use as an inactive ingredient in oral solid dosage forms.
7. How does PEG 4000 compare to PEG 6000?
PEG 6000 has a higher average molecular weight than PEG 4000 and tends to form a firmer, more rigid matrix, so the choice between the two depends on the specific hardness, melting point, and dissolution behavior required by the formulation.
8. What quality checks should I request from a PEG 4000 supplier?
Request confirmation of molecular weight range, hydroxyl number, appearance and solution clarity, ethylene glycol and diethylene glycol impurity levels, heavy metal limits, and compliance with the relevant USP-NF, BP, Ph. Eur., or IP monograph.
9. Where can I source pharmaceutical grade PEG 4000 in India?
PEG 4000 can be sourced from established Indian PEG manufacturers offering the full pharmaceutical grade range, specialty excipient exporters, and digital procurement platforms such as Clyzo, which allow formulators to compare documentation and request samples online.
PEG 4000 continues to be a workhorse excipient in solid dosage form manufacturing, valued for its combined role as a binder, lubricant, plasticizer, and film coating component. For pharmaceutical manufacturers in India, the priority when sourcing this excipient should be verifying consistent molecular weight and hydroxyl number data across batches, confirming pharmacopoeial compliance, and working with a supplier who can support the specific solid dosage application the formulation requires.
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