Item
|
Specification
|
Description
|
White to almost white crystalline powder
|
Identification
|
IR: Must complies with reference standard
HPLC: Must complies with reference standard
|
Absorbance
|
NMT 0.02
|
Water
|
NMT 2.0%
|
Residue on ignition
|
NMT 0.1%
|
Heavy metals
|
NMT 0.001%
|
Related compounds
-A
-B
-C
-Any other individual impurity
-Total impurities
|
NMT 1.0%
NMT 0.2%
NMT 0.1%
NMT 0.1%
NMT 0.3%(excluding R-isomer)
|
Residual solvents
-Ethyl acetate
-n-Hexane
-Methanol
-Toluene
|
NMT 5000ppm
NMT 290ppm
NMT 3000ppm
NMT 890ppm
|
Assay(HPLC)
|
Between 98.0% to 102.0%
|