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WHO-GMP Pharmaceutical Grade Calcium Carbonate 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% |
Calcium Carbonate Excipient (CAS 37025-55-1) is a pharmaceutical excipient widely used in solid and semi-solid pharmaceutical formulations. Calcium Carbonate 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 Calcium Carbonate 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 Calcium Carbonate 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.
Calcium Carbonate 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 Calcium Carbonate 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.
Calcium Carbonate 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 Calcium Carbonate Excipient to Indian formulation companies and international markets with consistent lot quality.
Yes, Calcium Carbonate 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 Calcium Carbonate 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 Calcium Carbonate Excipient supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Calcium Carbonate 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 Calcium Carbonate Excipient pricing, samples, and sourcing support.