Intermediate for Bedaquiline
|
Parameter |
Specifications Limit |
|
Appearance |
White to off white color powder |
|
Identification by HPLC |
The Retention time of the major peak in the chromatogram of test preparation corresponds to that in the chromatogram of system suitability preparation as obtained under purity by HPLC
|
|
Water Content by KF |
NMT 1.0%
|
|
Purity by HPLC
|
NLT 99.00%
|
|
Related Substance by HPLC Benzoic acid Any other individual impurity
|
NMT 1.0% NMT 0.2% |
|
Specific optical Rotation (1% n Acetone at 25oC)
|
In Between -7.0o and -11.0o |