Doxycycline Hyclate

TESTING ITEMS                               SPECIFICATION                

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