Description:
calcium chloride dihydrate chemically pure, crystalline, Ph. Eur. (Pharmacopoea Europaea),
USP (United States Pharmacopeia), JP (Japanese Pharmacopoeia)
| Specification: | |||
| appearance | fine white crystalline powder | ||
| identity | passes test | ||
| appearance of 10% water solution | clear and colourless | ||
| assay (CaCl2x2H2O) | 99,0 | – 103,0 | % |
| pH value (5%) | 4,5 | – 9,2 | |
| acidity (0,01 M NaOH/g) | ≤ | 0,20 | ml |
| alkalinity (0,01 M HCl/g) | ≤ | 0,20 | ml |
| aluminium (Al) | ≤ | 0,20 | mg/kg |
| barium | passes test | ||
| Mg2+ and alkali ions (SO42-) | ≤ | 0,50 | % |
| sulphate (SO42-) | ≤ | 240,0 | mg/kg |
| iron (Fe) | ≤ | 10,0 | mg/kg |
| heavy metals (as Pb) | ≤ | 5,0 | mg/kg |
| arsenic (as As2O3) | ≤ | 2,0 | mg/kg |
| lead (Pb) | ≤ | 2,0 | mg/kg |
| mercury (Hg) | ≤ | 1,0 | mg/kg |
| cadmium (Cd) | ≤ | 1,0 | mg/kg |
| substances precipitated by ammonia (Al, Fe, PO43-) | passes test | ||
| hypochlorite (ClO–) | passes test | ||
This product complies to the requirements according to ICH (International Conference on
Harmonisation) Guideline Impurities: “Residual solvents” (CPMP/ICH/283/95) – Ph. Eur.
and/or USP.