
Appearance
Slightly yellow crystal powder almost ordeless
Conforms
Identification
Conforms
Conforms
Melting point
60ºC -62ºC
62ºC
Loss on drying
0.20% Max
0.18%
Residue on ignition
0.10% Max
0.06%
Specific rotation
-1.0º― +1.0º
Conforms
Limit of polymer content
2.0% max
Conforms
Related Substances by HPLC
6,8-Epitrithleoctanolic acid(EPI)
0.10% Max
0.09%
Single impurities
0.10% Max
0.04%
Total Impurities
0.50% Max
0.30%
Residue by GC
Cyelohexane
1000 PPM Max
940 PPM
Ethyl acetate
250 PPM Max
180 PPM
Toluene
20 PPM Max
16 PPM
Total acrobes counts
1000cfu/g Max
100 cfu/g
Moulds and yeasts
100cfu/g Max
Less than 10 cfu/g
E.coli/Salmonella
Absence/g
Not detectable
Staphyloeaccus nureate
Absence/g
Not detectable
Particle size
100% through 40 mesh
conforms
Losse bulk density
0.279g/ml
Assay
99.0-101.0%
99.54%
Result: The product conform to USP28

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