Medical calcium carbonate
Implementation standard for raw material calcium carbonate products: current version of the Chinese Pharmacopoeia.
It can also implement enterprise internal control standards, which are superior to the current version of the Chinese Pharmacopoeia,
Meet the requirements of the United States Pharmacopeia and the European Pharmacopoeia.
Drug registration approval number: National Medical Products Administration Approval Number H20173018.
|
project |
index |
|
character |
This product is a white, extremely fine crystalline powder |
|
Identify I |
Positive reaction |
|
chloride |
≤0.03% |
|
sulfate |
≤0.2% |
|
Insoluble substances in acid |
≤0.2% |
|
Dry weight loss |
≤1.0% |
|
Barium salt |
Through experimentation |
|
Magnesium and alkali metal salts |
≤1.0% |
|
ferric salt |
≤0.04% |
|
cadmium |
≤2 mg/kg |
|
mercury |
≤0.5 mg/kg |
|
arsenic |
≤4mg/kg |
|
heavy metal |
≤30mg/kg |
|
Calcium carbonate content |
≥98.5% |
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