| Assay (4Perchloric acid titration, calc. on anhydrous substance (Ph Eur)) |
99.0 - 101.0 % |
| Assay (perchloric acid titration, calc. on dried substance (USP)) |
99.0 - 100.5 % |
| Assay (Perchloric acid titration, previously dried substance (JP)) |
99.0 - 101.0 % |
| Identity (Na) |
passes test |
| Identity (Citrate) |
passes test |
| Identity (reaction upon ignition) |
passes test |
| Appearance |
white crystals |
| Appearance of solution (100 g/l, CO₂-free water) |
clear and colorless |
| Acidity or alkalinity |
passes test |
| pH (50 g/l CO₂-free water) |
7.5 - 8.5 |
| In water insoluble matter # |
≤ 50 ppm |
| Chloride (Cl) |
≤ 30 ppm |
| Sulfate (SO₄) |
≤ 50 ppm |
| Heavy metals (as Pb) |
≤ 5 ppm |
| Al (Aluminium) |
≤ 5 ppm |
| As (Arsenic) |
≤ 2 ppm |
| NH4 (Ammonium) # |
≤ 30 ppm |
| Ca (Calcium) # |
≤ 50 ppm |
| Fe (Iron) # |
≤ 5 ppm |
| Oxalate (as C₂H₂O₄) |
≤ 300 ppm |
| Tartrate (C₄H₄O₆) |
passes test |
| Residual solvents (ICH (Q3C)) |
excluded by manufacturing process |
| Readily carbonisable substance |
passes test |
| Water (according to Karl Fischer) |
11.0 - 13.0 % |
| Loss on drying (180 °C, 18 h) |
10.0 - 13.0 % |
| Total aerobic microbial count (TAMC) |
≤ 100 CFU/g |
| Total combined yeasts/moulds count (TYMC) |
≤ 10 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 |
| Bacterial endotoxins |
≤ 2.5 I.U./g |
| # Additional requirements by ACSElemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). |
|
| Corresponds to Ph. Eur., BP, JP, USP, ACS |
|
