High Quality Doxycycline Hydrochlocide

Yellow crystalline powder
antibiotics drug
Items
SPECIFICATION
RESULT
Appearance
Yellow crystalline powder
Complies
Identification
As Stipulated
Complies
Identification A
HPLC
Complies
Identification B
Sulphuric acid reaction a yellow colour develops
Complies
Identification C
It gives reaction of chlorides
Complies
Heavy Metal
≤50ppm
<50ppm
pH
2.0-3.0
2.5
Related substance
a) 6-epidoxycycline≤2.0%
1.8%
b) metacycline≤2.0%
0.2%
c) 4-epidoxycycline≤0.5%
Not found
d) 4-epi-6-epidoxycycline≤0.5%
Not found
e) oxytetracyclie ≤0.5%
Not found
f) 2-acety-2-decarbamoyldoxycycline ADOT ≤0.5%
Not found
g) any other impurity ≤0.5%
Not found
h) not identified impurities≤0.1%
Not found
Specific Optical Rotation
-105~ -120°
-112°
Specific absorbance
At 349 nm E(1%) 300-335
323
Light absorbing impurities
At 490 nm ≤0.07
0.02
Ethanol
4.3-6.0% (m/m)
4.9%
Water
1.4-2.8%
1.9%
Sulphated ash
≤0.4%
0.1%
Assay
95.0%-102.0% (C22H25ClN2O8) based on anhydrous, ethanol-free substance
99.3%