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Inspection Item Specification Results
Identification Infrared Absorption Conform
Description White or Almost White Crystalline conform
Assay 97-103% 99.22%
Melting point 98-104℃ 99.0-101℃
Specific rotation +85?#65374;+92?+88.5?
Loss on drying 0.5% Max 0.19%
Residue on ignition 0.2% Max 0.05%
Free Cyclopentanepropionic acid 0.2%max Conform
Organic Volatile Impurities meets the requirement Conforms
Residual Solvents Benzene: 2PPm max
Ethyl Acetate: 5000PPm max
Pyridine: 200PPm max <2PPm
<5000PPm
<200PPm
Conclusion : THE PRODUCT CONFORM TO USP30

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