ITEMS |
SPECIFICATIONS |
RESULTS |
Characters |
Yellow crystalline powder |
Complies |
Identification |
a):TLC. b):Sulphuric acid reaction a yellow colour develops c):It gives reaction of chlorides |
Complies |
Assay |
88.0%~94.0%(C22H24N2O8) Based on anhydrous ethanol-free substance |
90.5% |
PH |
2.0~3.0 |
2.4 |
Specific optical rotation |
E (1%) is 300~335 at 349nm |
325 |
Heavy Metals |
â¤50ppm |
20ppm |
Specific optical rotation |
-1050~-1200 |
-1130 |
Light-absorbing impurities |
At490nmâ¤0.07 |
0.02 |
Related substances |
a) : β-epidoxycyclineâ¤2.0% b):metacyclineâ¤2.0% c):any other impurityâ¤0.5% |
1.8% 0.3% Not found |
Ethanol |
4.3~6.0%(m/m) |
4.7% |
Sulphated ash |
â¤0.4% |
0.05% |
Weter |
1.4~2.8% |
2.0% |
Conclusion: |
Conform to BP2005 |
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