Get Quote
Get Quote
WHO-GMP Pharmaceutical Grade Butylene Glycol Excipient – Pharmaceutical Grade Excipient
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Butylene Glycol Excipient (CAS 37025-55-1) is a pharmaceutical excipient widely used in solid and semi-solid pharmaceutical formulations. Butylene Glycol serves critical roles in drug product manufacturing including binding, filling, coating, stabilising, or modifying the release profile of active pharmaceutical ingredients depending on concentration and processing method. It complies with IP/BP/EP/USP pharmacopeial specifications for pharmaceutical manufacturing use.
Quality specifications for Butylene Glycol as a pharmaceutical excipient include appearance, pH, viscosity or particle size where applicable, loss on drying, heavy metal limits, and microbial count per relevant pharmacopeial monograph. Pharmaceutical manufacturers demand batch-to-batch consistency in functional excipient properties that directly affect tablet hardness, disintegration time, and drug release kinetics.
Swapnroop Drugs and Pharmaceuticals supplies Butylene Glycol Excipient from our WHO-GMP certified Aurangabad facility with full pharmacopeial compliance, complete CoA, MSDS, and origin documentation. We serve formulation companies, CDMO partners, and research laboratories in India and 25+ export countries with consistent quality pharmaceutical excipient supply.
Butylene Glycol Excipient is supplied in food-grade polyethylene-lined fiber drums (25 kg net) or HDPE pails (5 kg) with desiccant. Stored at controlled temperature and humidity per pharmacopeial storage conditions to maintain functional excipient properties.
Get Bulk QuoteThe CAS number for Butylene Glycol is 37025-55-1. It is a pharmaceutical grade excipient classified as a Pharmaceutical Grade Excipient used in solid and semi-solid dosage form manufacturing.
Butylene Glycol Excipient is available in USP/NF, BP, and IP pharmacopeial grades with complete Certificate of Analysis covering all quality specifications for pharmaceutical manufacturing.
Testing includes identification (IR), particle size distribution (laser diffraction), loss on drying, residue on ignition, heavy metals, pH, viscosity (if applicable), and microbiological limits per pharmacopeial specifications.
Minimum order is 25 kg with competitive pricing for 100 kg and above. We supply Butylene Glycol Excipient to Indian formulation companies and international markets with consistent lot quality.
Yes, Butylene Glycol Excipient in the appropriate pharmacopeial grade is suitable for direct compression, wet granulation, dry granulation, and other solid dosage manufacturing processes depending on its specific functional properties.
Swapnroop Drugs and Pharmaceuticals is a trusted Butylene Glycol Excipient manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Butylene Glycol Excipient supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Butylene Glycol Excipient exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Butylene Glycol Excipient pricing, samples, and sourcing support.