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Doxycycline Hyclate or Doxycycline Hydrochloride or Doxycycline Hcl CAS 24390-14-5 
Product Name: Doxycycline Hyclate
Synonyms: Doxycycline Hydrochloride, Doxycycline Hcl, Doxycyclini hyclas
CAS Number: 24390-14-5
Characteristics: Yellow hygroscopic crystalline powder.
Assay: 95%~102%
Formula: C22H24N2O8,HC1,½C2H6O,½H2O Molecular Weight: 512.9
Package: 25Kg/Fiber Drum
Drum Size: Diameter 41Cm, Height 40Cm
According to: EP, BP, USP
Usage: Doxycycline Hyclate belongs to tetracycline antibiotic. It is also called Doxycycline Hydrochloride, Doxycycline Hcl. In Latin or some other country: Doxycyclini hyclas
It is the raw material to manufacture Doxycycline Hyclate Capsules, Doxycycline Hyclate Tablets, etc.
Doxycycline Hyclate is also widely used in Veterinary Drugs manufacturing process.
Certificate of Analysis -- Doxycycline Hyclate
Testing Item |
Standard |
Result |
Appearance |
Yellow crystalline powder |
Complies |
Identification A |
Should comply with TLC Result |
Complies |
Identification B |
Color reaction with sulfuric acid |
Complies |
Identification C |
Color reaction with silver nitrate |
Complies |
pH |
2.0 ~ 3.0 |
2.4 |
Heavy Metal |
≤50ppm |
<50ppm |
Solubility |
Should Comply. |
Complies |
Specific Optical Rotation |
-105~ -120° |
-115° |
Related Substance |
a) 6-epidoxycycline ≤ 2.0% |
1.1% |
b) Metacycline ≤ 2.0% |
0.1% |
|
c) 4-epidoxycycline ≤ 0.5% |
< 0.1% |
|
d) 4-epi-6-epidoxycycline ≤ 0.5% |
< 0.1% |
|
e) Oxytetracyclie ≤ 0.5% |
< 0.1% |
|
f) 2-acety-2-decarbamoyldoxycycline ≤0.5% |
Not found |
|
g) any other impurity ≤0.5% |
< 0.1% |
|
h) not identified impurities≤0.1% |
Not found |
|
|
Specific absorbance (At 349nm) |
300-335 |
320 |
|
Light absorbing impurities (At 490nm) |
≤ 0.07 |
0.02 |
Ethanol |
4.3% ~ 6.0% (m/m) |
4.9% |
Moisture |
1.4% ~ 2.8% |
1.9% |
Sulphated ash |
≤ 0.4% |
0.05% |
|
Assay (Doxycycline Hyclate) |
95.0% ~ 102.0% (C22H25ClN2O8) based on anhydrous, ethanol-free substance |
99.3% |
