TEST | SPECIFICATION |
Description | White to yellowish powder. |
Identification | Complies test BP 2009. |
pH | Between 6.0 and 7.5 (USP 32) |
Loss on drying: Residue on ignition: Chlorides: | NMT 1.0 % (USP 32). NMT 0.2 % (USP 32). NMT 0.06 % (USP 32). |
Heavy Metals: | Max. 20 ppm. |
Particle size: | Pass mesh 1400μm: NLT 95%.Pass mesh 150μm: NLT 35%. |
Purity (HPLC): | Total impurities: NMT 1.0% (USP 32) |
Assay (HPLC): | Between 96.0% and 99.0 %on dried basis (USP 32) |