Product Name: DOXYCYCLINE HYCLATE

Appearance

Yellow or yellow crystalline powder

yellow crystalline powder

Solubility

Conforms to BP2012

Complies

Identification

1) tR of HPCL test meets    requirement

Complies

2) Sulphuric acid yellow Color    reaction

Complies

3) Chloride’ reaction

Complies

pH

2.0-3.0

2.4

Specific optical rotation

-105°to    -120°

-112°

Specific absorbance

300-335 at 349nm

328

Light-absorbing impurities

≤0.07

0.03

Related substances

a)6-epidoxycycline≤2.0%

1.4%

b)metacycline≤2.0%

0.5%

c)4-epidoxycycline≤0.5%

Not found

d)4-epi-6epidoxycycline≤0.5%

Not found

e)oxytetracycline≤0.5%

Not found

f)2-acety-2-decarbamoyl    doxycycline≤0.5%

Not found

g)any other impurity≤0.5%

Not found

Ethanol

4.3%~6.0%

5.0%

Heavy metal

≤50ppm

Complies

Water

1.4%~2.8%

2.0%

Sulfated ash

≤0.4%

0.06%

Assay

95.0%~102.0% of C22H25ClN2O8    （anhydrous ethanol-free substance）

98.6%