| Assay (complexometric) |
98.5 - 102.0 % |
| Identity (IR-spectrum) |
passes test |
| Identity (TLC) |
passes test |
| Identity (Calcium) |
passes test |
| Appearance |
white or almost white, crystalline powder |
| Appearance of solution (20 g/l, water) |
passes test |
| pH (50 g/l; water) |
6.0 - 8.0 |
| Chloride (Cl) |
≤ 200 ppm |
| Sulphate (SO₄) |
≤ 100 ppm |
| Oxalate (C₂O₄) |
≤ 100 ppm |
| Phosphate (PO₄) |
≤ 100 ppm |
| Heavy metals (as Pb) |
≤ 10 ppm |
| As (Arsenic) |
≤ 3 ppm |
| Cu (Copper) |
≤ 25 ppm |
| Fe (Iron) |
≤ 5 ppm |
| Pb (Lead) |
≤ 2 ppm |
| Zn (Zinc) |
≤ 25 ppm |
| Magnesium and alkali metals |
≤ 0.4 % |
| Organic substances and boric acid |
passes test |
| Residual solvents (Ph.Eur./USP/ICH) |
excluded by manufacturing process |
| Organic volatile impurities (USP/NF) |
conforms |
| Reducing substances (USP) |
≤ 1.0 % |
| Sucrose and reducing sugars |
passes test |
| Loss on drying (105 °C, 16 h) |
≤ 2.0 % |
| Total aerobic microbial count (TAMC) |
≤ 1000 CFU/g |
| Total combined yeasts/moulds count (TYMC) |
≤ 100 CFU/g |
| Bile-tolerant gram-negative bacteria (absent in 1 g) |
passes test |
| Candida albicans (absent in 1 g) |
passes test |
| Escherichia coli (absent in 1 g) |
passes test |
| Pseudomonas aeruginosa (absent in 1 g) |
passes test |
| Salmonella (absent in 10 g) |
passes test |
| Staphylococcus aureus (absent in 1 g) |
passes test |
| Residues of metal catalysts or metal reagents acc.to EMEA/CHMP/SWP/4446/2000 are not likely to be present. This product is not intended for use in preparing injectable dosage forms. |
|
| Corresponds to Ph Eur,BP,USP,FCC,E 578 Conforms to the purity criteria on food additives according to the European Commission directive 2008/84/EC. |
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