|
ITEMS
|
SPECIFICATION
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RESULTS
|
|
Character
|
White or almost white crystalline powder
|
Almost White crystalline powder
|
|
Specific optical rotation
|
+47°to +53°
|
+48.2°
|
|
Impurity F
|
Not more than 0.5%
|
<0.5%
|
|
Identification
|
Complies by IR
|
Conforms
|
|
Related substances
|
Impurity A not more than 0.3%
|
Undetected
|
|
|
Impurity B not more than 0.7%
|
Undetected
|
|
|
Impurity C not more than 0.2%
|
Undetected
|
|
|
Impurity D not more than 1.0%
|
0.36%
|
|
|
Impurity E not more than 0.2%
|
Undetected
|
|
|
Impurity G not more than 0.2%
|
Undetected
|
|
|
Impurity H not more than0.10%
|
0.08%
|
|
|
Impurity I not more than 0.2%
|
Undetected
|
|
|
Unknown impurity not more than 0.10%
|
0.05%
|
|
|
Total impurity not more than 1.5%
|
0.49%
|
|
Loss on drying
|
Not more than 1.0%
|
0.20%
|
|
Methylene chloride
|
Not more than 300ppm
|
84ppm
|
|
Methanol
|
Not more than 2000ppm
|
116ppm
|
|
Assay
|
Contains 97.0% to 103.0% of C24H34O4
|
99.80%
|
|
Calculated on dried basis
|
|
Conclusion
|
The goods conforms to EP6.0
|
