〉 not more than 1.5% 0.6 %
Heavy metals not more than 0.0025% passes
Chromatographic purity 〈621〉 not more than 0.3% of any individual
impurity is found and not more than
0.8% of total impurities
requirement
Residue on ignition 〈281〉 not more than 0.2% from 250 mg passes
Chromatographic purity 〈621〉 not more than 1% of any individual
impurity is found and not more than
2% of total impurities is found
requirement
Residue on ignition 〈281〉 not more than 0.2% from 250 mg passes
Chromatographic purity 〈621〉 not more than 1% of any individual
impurity is found and not more than 2%
of total impurities is
3.0
Chromatographic purity 〈621〉 not more than 0.5% of any individual
impurity is found, and not more than
1.0% of total impurities is found
passes
Assay - HPLC 〈621〉 not less than 97% and not
than 0.5% passes
Residue on ignition 〈281〉 not more than 0.2% passes
Chromatographic purity 〈621〉 to pass test passes
Organic Volatile impurities
Method IV 〈467〉
meets requirements passes
than 0.5% passes
Residue on ignition 〈281〉 not more than 0.2% passes
Chromatographic purity 〈621〉 to pass test passes
Organic Volatile impurities
Method IV 〈467〉
meets requirements Meets