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Conforms
Specific optical rotation
+28o~+35o
+33.4o
Identification
IR,TLC
Positive
Heavy Metals
10PPm
Assay
97.0%
97.13%
Related substances
3.0%max
Free Acid
0.5%max
0.16%
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?0.5%
0.24%
Optical rotation
+79°~+83°
81.4°
(HPLC)Assay
97-103.0%
98.31%
Free acid
0.5%max
0.36%
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White powder
Loss on drying
?0.5%
0.24%
Optical rotation
+86°~+91°
88.5°
Melting Point
112~117°C
114-116°C
(HPLC)Assay
97-103.0%
98.81%
Free acid
0.5%max
0.21%
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Pharmaceutical Intermediates in Skyp : Hormonepowder chen
crystalline powder
Conform
Loss on drying
?0.5%
0.24%
Optical rotation
+68°~+72°
70.3°
Melting Point
60~65°C
61-63°C
(HPLC)Assay
97-103.0%
98.71%
Free acid
0.5%max
0.35%
Conclusion
The aboye product conforms analysis standard
HPLC:
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Pharmaceutical Intermediates in Skyp : Hormonepowder chen
powder
conform
Assay
97 ~ 103%
99.18%
Loss on drying
=0.5%
0.15%
Identification
Positive
conform
Specific optical rotation
?77°~?82°
+79.3°
Melting point
32 ~ 37?
34~36?
Free heptanoic acid
=0.2%
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