CHARACETRS:

YELLOW CRYSTALLINE POWDER

CONFORMS

IDENTIFICATION:

TLC

CONFORMS

SULPHURIC ACID REACTION A YELLOW COLOUR DEVELOPS

CONFOMS

IT GIVES REACTION OF CHLORIDES

CONFOSM

PH

2.0~3.0

2.4

SPECIFIC ABSORBANCE

AT 349nm E(1%) 300~355

320

SPECIFIC OPTICAL ROTATION

-105 ~ -120°

-110°

HEAVY METALS:

≤50PPM

< 20PPM

LIGHT-ABSORBING IMPURITIES

AT 490nm  ≤0.07

0.04

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)

1.8%

0.1%

NOT FOUND

NOT FOUND

NOT FOUND

NOT FOUND

NOT FOUND

ETHANOL

4.3~6.0% (m/m)

4.6%

SULPHATED ASH

≤0.4%

0.06%

WATER

1.4~2.8%

2.0%

ASSAY

95.0~102.0% ( C22H25ClN2O8) 

Based on anhydrous, ethanol-free substance

98.5%