DOXYCYLINE HYDROCHLORIDE

DOXYCYLINE HYDROCHLORIDE 95.0%~102.0%
Appearance
Yellow crystalline powder
Complies
Identification
A) t
R
of HPLC test
Complies
B) Sulphuric acid yellow color reaction
C) Chloride’s reaction
PH
2.0~3.0
2.5
Specific optical rotation
-105°~ -120°, Calculated on the anhydrous, ethanol-free substance
-110°
Specific Absorbance
300-335 at 349nm, Calculated on the anhydrous, ethanol-free substance
319
Light-absorbing Impurities
NMT 0.07 at 490nm, Calculated on the anhydrous, ethanol-free substance
0.02
Related substances
Metacycline: NMT2.0%
Conforms
6-epidoxycycline: NMT2.0%
Any Individual impurities: NMT0.5%
Disregard limit: NMT0.1%
Ethanol
4.3 to 6.0%
4.8 %
Heavy Metals
Less than 50 ppm
< 50 ppm
Water
1.4% to 2.8%
1.9%
Sulphated Ash
Not More Than 0.4%
0.1%
Assay
95.0%~102.0% of C
22
H
25
ClN
2
O
8
,Calculated on the anhydrous, ethanol-free substance
100.4 %
CONCLUSION: THE ABOVE PRODUCT CONFORMS TO BP2007