ITEMS
|
SPECIFICATION
|
RESULT
|
Appearance
|
White to off-white powder
|
Conforms
|
Melting point
|
167 〜171°C
|
167.5 〜168.0°C
|
Specific optical rotation
|
-28.5°〜-24.5°
The retention time of the major peak of the test
|
-27.2°
|
Identity
|
The retention time of the major peak of the test solution corresponds to that of the standard solution, as obtained in the Assay.
|
Conforms
|
The infrared absorption spectrum of this
product should corresponds to the reference spectrum.
|
Conforms
|
Crystallinity
|
There are characteristic peaks at 7.7°±0.2°,9.9°±0.2°, 17.8°±0.2°, 19.5°±0.2°, 20.0°± 0.2°(Crystal form 1).
|
Conforms
|
Water content (%w/w)
|
≤0.5%
|
0.1%
|
Residue on ignition
|
≤0.1%
|
0.02%
|
Related substances
|
QR0005DS-IN-01: ≤0.10%
QR0005DS-IN-02: ≤0.10%
QR0005DS-IM-08: ≤0.10%
QR0005DS-IM-06: ≤0.10%
Other maximum unknown impurity ≤0.10%
Total impurities: ≤0.40%
|
Not detected
0.01%
Not detected
Not detected
0.02%
0.07%
|
Enantiomeric and
diastereoisomer
|
QR0005DS-IM-02: ≤0.10%
QR0005DS-IM-03: ≤0.10%
QR0005DS-IM-04: ≤0.10%
QR0005DS-IM-01+QR0005DS-IM-05+ QR0005DS-IM-06: ≤0.10%
QR0005DS-IM-07 ≤0.10%
Total isomer impurities: ≤0.50%
|
0.01%
Not detected
Not detected
Not detected
Not detected
0.02%
0.04%
|
Residual solvents
|
Methanol: ≤3000 ppm
Dichloromethane: ≤600 ppm
Acetone: ≤5000 ppm
Ethanol: ≤5000 ppm
Dimethyl sulfoxide: ≤5000 ppm
|
31 ppm
53 ppm
Not detected
Not detected
Not detected
|
Benzene
|
≤2 ppm
|
Not detected
|
Heavy metals
|
≤10 ppm
|
Conforms
|
Bacterial endotoxin
|
≤0.25 EU/mg
|
Conforms
|
Microbial limit
|
Total Aerobic Microbial Count (TAMC): ≤102 cfu/g
Total molds and Yeast Count (TYMC): ≤101cfu/g
Escherichia Coli: Absence
|
10 cfu/g
< 10 cfu/g
Not detected
|
Assay
|
C37H42F2N8O4: 98.0% 〜102.0% (on the anhydrous basis)
|
101.0%
|
Conclusion
|
Conform to Enterprise Standard
|