TEST | SPECIFICATION |
1.Solubility | Freely soluble in water, slightly soluble in alcohol 96%v/v. |
2.Description | White to yellowish powder. |
3.Identification | Complies test EP Ed 6.8. |
4.Appearance of the Solution | Complies test EP Ed 6.8. |
5.pH | Between 2.4 and 3.0 (EP Ed 6.8) |
6.Related substances | Impurity B: NMT 0.15% Unknown individual impurities: NMT 0.10% Total impurities: NMT 0.2% |
7.Loss on drying: 8.Residue on ignition: | NMT 0.5 % (EP Ed 6.8). NMT 0.1 % (EP Ed 6.8). |
9.Heavy Metals: | Max. 20 ppm (EP Ed 6.8). |
10.Particle size: | Pass mesh 1400μm: NLT 95%.Pass mesh 150μm: NLT 35%. |
11.Assay (HPLC): | Between 96.0% and 99.0 %on dried basis (EP Ed 6.8). |