specifications (Current through USP 23, 10th Supplement), and is traceable to USP Reference
Standard lot L
Ampule sealed under argon. Protect from light. Store sealed ampule at ≤ 8°C. Bring ampule to room
specifications (Current through USP 23, 10th Supplement), and is traceable to USP Reference
Standard lot L
Ampule sealed under argon. Protect from light. Store sealed ampule at ≤ 8°C. Bring ampule to room
Chromatographic purity 〈621〉 not more than 0.2% of any individual
impurity is found, and not more than
0.3% of total impurities is found
passes
Assay - HPLC 〈621〉 not less than 97% and not
to standard conforms to USP RS lot M
Identification B
High pressure liquid chromatography
〈621〉
retention time of the major peak in the
chromatogram of the assay preparation
corresponds
changes through violet and
blue to green
passes
Identification D
Thin layer chromatography 〈621〉
compares to standard passes
Melting range, °C
Class 1b 〈741〉
between 115° and 119° 115°-117