Description
Technical Parameters
|
Items |
Standard |
|
Appearance |
White to off-white power |
|
Solubility |
Soluble in methanol |
|
Identification |
HPLC retention time correspond to standard preparation under assay item |
|
Residue on Ignition |
NMT 0.50% |
|
Loss on drying |
NMT 0.50% |
|
Related substance |
Unspecified impurity: NMT 0.50% Total impurities: NMT 1.0% |
|
Chiralimpurity |
R-isomer: NMT 1.0% |
|
Assay |
NLT 98.0% and NMT 102.0% (on dried basis) |
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