PEG 4000 – Versatile excipient, optimal laxative and pharmaceutical formulation solution from India
1. General Introduction to PEG 4000
PEG 4000 (Polyethylene Glycol 4000 or Macrogol 4000) is a synthetic polymer with a medium molecular weight, notable for its excellent water solubility, high chemical stability, and absolute biological safety. This substance is widely used both as a primary active ingredient (osmotic laxative) and as a multifunctional excipient in pharmaceutical formulations and health supplement products.
The raw material is manufactured by Nitika Pharmaceutical Specialities Pvt. Ltd. (India), one of the world's leading specialized excipient manufacturers with international GMP certification. With an advanced synthesis and purification process, Nitika's PEG 4000 achieves optimal purity, strictly controls harmful impurity indices, ensures absolute consistency across production batches, and fully complies with the most stringent global pharmacopeial standards.
2. PEG 4000 Material Information
Material Name: PEG 4000 / Polyethylene Glycol 4000 (Macrogol 4000)
Category: Pharmaceutical Excipients / Active Pharmaceutical Ingredient (API) for laxative products.
Function: Osmotic laxative API, binder, plasticizer for film coating, suppository and ointment base.
Chemical Composition: Polymer of ethylene oxide and water, general formula H(OCH2CH2)nOH (with average n corresponding to a molecular weight of approximately 4000).
Form: Fine crystalline powder or white flakes, odorless or with a faint characteristic odor.
Solubility: Very soluble in water, freely soluble in ethanol and chloroform, practically insoluble in ether and fatty oils.
Quality Standards: Complies with United States Pharmacopeia (USP), European Pharmacopoeia (EP), British Pharmacopoeia (BP), or Indian Pharmacopoeia (IP) standards.
The raw material is strictly controlled for:
Toxic Impurity Limits: Strict control of Ethylene Glycol and Diethylene Glycol (EG/DEG) levels to extremely low thresholds below international pharmacopeia limits, ensuring absolute safety for oral consumption.
Molecular Weight Range: Ensures a precise molecular weight distribution from 3600 - 4400 g/mol to maintain stable osmotic pressure and viscosity.
Heavy Metals and Microbial Limits: Meets strict microbiological standards for both oral and topical preparations.
3. Advantages of PEG 4000 from Nitika
High Purity and Absolute Safety: Nitika's organic impurity (DEG, EG) control process is extremely rigorous, completely eliminating toxicity risks, ensuring safety for long-term use even for sensitive demographics like children and the elderly.
Safe Mechanical Mechanism of Action: When used as a constipation treatment, PEG 4000 works by binding to water molecules in the intestinal tract, increasing fluid volume and softening stools without being absorbed into the systemic circulation, avoiding colonic mucosa irritation or electrolyte imbalance.
Superior Formulation Properties: Possesses high thermal stability, good overall stability, and compatibility with most common active pharmaceutical ingredients, helping to improve tablet hardness and film coating flexibility.
Reasonable Cost - Stable Supply: Manufactured in India by Nitika, the product offers highly competitive pricing compared to European sources, providing an effective solution for manufacturing plants to optimize production costs.
4. Applications of PEG 4000
In Pharmaceuticals (Primary Applications)
Constipation Treatment: Serves as the primary active ingredient (API) for osmotic laxative oral suspension powders.
Excipient for Tablets and Capsules: Used as a dry binder, lubricant, or plasticizer in film coating formulations to ensure smooth, glossy, and crack-free tablet coatings.
Suppositories and Ointments: Acts as a water-soluble base for rectal suppositories, vaginal suppositories, or topical creams and ointments, facilitating rapid active ingredient release and easy washing.
In Health Supplements
Digestive Support Products: Applied in probiotic granules, soluble fiber powders, or supplements that relieve constipation and regulate bowel movements.
Solubilizer and Stabilizer: Helps increase the solubility of poorly soluble active ingredients in nutritional supplement formulations.
5. Commercial Products Using PEG 4000
6. Product Contact Information
For more information on the supply chain, PEG 4000 technical specifications, or to place an order, please contact us:
Sample/COA Request: Please contact us via email to request a sample and the latest Certificate of Analysis (COA) of the raw material from the manufacturer, Nitika Pharmaceutical Specialities Pvt. Ltd.
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Standard PEG 4000 from Nitika Pharmaceutical Specialities Pvt. Ltd. (India). High-quality pharmaceutical grade ingredient, acting as an effective osmotic laxative and versatile excipient in the formulation of tablets, ointments, and suppositories. Contact Biorich now!
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