CHARACETRS: | YELLOW CRYSTALLINE POWDER |
IDENTIFICATION: | HPLC |
SULPHURIC ACID REACTION A YELLOW COLOUR DEVELOPS | |
IT GIVES REACTION OF CHLORIDES | |
PH | 2.0~3.0 |
SPECIFIC ABSORBANCE | AT 349nm E(1%) 300~355 |
SPECIFIC OPTICAL ROTATION | -105 ~ -120° |
HEAVY METALS: | ≤50PPM |
LIGHT-ABSORBING IMPURITIES | AT 490nm ≤0.07 |
RELATED SUBSTANCES | 6-EPIDOXYCYCLINE ≤2.0% METACYCLINE≤2.0% 4-EPIDOXYCYCLINE≤0.5% (EP5) 4-EPI-6-EPIDOXYCYCLINE≤0.5% (EP5) OXYTETRACYCLINE≤0.5% (EP5) ANY OTHER IMPURITY≤0.5% NOT IDENTIFIED IMPURITIES≤0.1% (EP5) |
ETHANOL | 4.3~6.0% (m/m) |
SULPHATED ASH | ≤0.4% |
WATER | 1.4~2.8% |
ASSAY | 95.0~102.0%( C22H25ClN2O8) BASED ON ANHYDROUS,ETHANOL-FREE SUBSTANCE |