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Doxycycline Hyclate
Name:Doxycycline Hyclate
CAS:24390-14-5
MF:C22H26N2O9
The detailed specifications are as below:
Items  Specification Result 
Appearance Yellow crystalline powder hygroscopic  conforms
Solubility It is freely soluble in water or methanol,sparingly soluble in ethanol(96%), in dissolves in solutions of alkali in hydroxides and carbonates conforms
Identification   Examine the chromatograms obtained in the assay conforms
Reaction with sulphuric acid conforms
Reaction with of chlorides conforms
PH  2.0~3.0 2.4
Specific Optical Rotation   -105° ~ -120° -112°
Specific absorbance(349nm) 300~335 318
Light-absorbing impurities(490nm) ≦0.07 0.02
Related 

Substances 

 
Impurity A (6-epidoxycycline ≦2.0% 1.76%
Impurity B (Metacycline )   ≦2.0% 0.16%
Impurity C ≦0.5% Not found
Impurity D ≦0.5% Not found

Related 
Substances 
Impurity E ≦0.5% Not found
Impurity F ≦0.5% 0.35%
Any other impurity ≦0.5% Not found
Ethanol   4.3%~6.0% 5.1%
Heavy Metals  Less Than 50ppm   <30ppm
Water   1.4% to 2.8%    1.9%
Sulfated Ash  ≦0.4% conforms
Assay    95.0%~102.0% 97.3%