Made from high-purity natural calcite through crushing, grinding, classification and purification processes, it strictly controls heavy metal and microbial indicators, fully complying with USP, EP and Chinese Pharmacopoeia requirements. Compared with light calcium carbonate, it has more uniform particle size and higher bulk density, which is not easy to fly during formulation mixing, facilitating workshop production operations. Its mild pH value will not cause adverse reactions with drug active ingredients, can stabilize the physical and chemical properties of preparations, solve the problem of abnormal drug dissolution caused by common pharmaceutical fillers, and has excellent biocompatibility without irritation.
Appears as white fine crystalline powder, odorless and tasteless; average particle size 10-20μm; specific surface area 1.5-2.0m²/g; purity ≥99.5%; moisture content ≤0.15%; pH value of 10% suspension 8.5-9.5; lead ≤5ppm, arsenic ≤1ppm, cadmium ≤0.5ppm; microbial limit: total aerobic count ≤1000cfu/g, mold and yeast ≤100cfu/g, Salmonella and E. coli not detected; packaged in pharmaceutical grade moisture-proof paper drums, 10kg per drum, with quality inspection report; stored in a cool, dry and well-ventilated warehouse, away from fire and strong acids and alkalis.
Mainly used as filler for oral tablets and capsules, which can effectively increase the volume of preparations, facilitate tableting, and adjust the disintegration time of tablets to improve the dissolution rate of drugs; used as a base regulator for medical ointments to improve the consistency and extensibility of ointments; used as an active ingredient raw material for calcium supplement drugs to prepare calcium carbonate oral solutions, chewable tablets and other preparations; also used for filling and modification of pharmaceutical packaging materials to improve the mechanical properties and barrier properties of packaging.
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