NaturChem Barcelona

Doxycycline HCL

Broad-spectum antibiotic
DOXYCYCLINE HYCLATE EP BP             
TEST SPECIFICATION
1.Characters Yellow crystalline powder
2. Solubility Freely soluble in water and in methanol, sparingly soluble in ethanol (96 per cent). It dissolves in solutions of alkali Hydroxides and carbonates
3. Identification a) HPLC b) Sulphuric acid reaction a yellow colour develops c) It gives reaction of chlorides
4. pH 2.0   ̴ 3.0
5. Specific Absorbance   At 349 nm E(1%) 300   ̴ 335 (anhydrous and ethanol-free substance)
6. Specific optical rotation -120°   ̴  -105° (anhydrous and ethanol-free substance)
7. Heavy metals ≤ 50 ppm
8. Light-absorbing impurities   At 490 nm ≤ 0.07
(anhydrous and ethanol-free substance)
9. Related substances a) 6-epidoxycycline ≤ 2.0%
b) metacycline ≤ 2.0%
c) 4-epidoxycycline ≤ 0.5%
d) 4-epi-6-epidoxycyclene ≤ 0.5%
e) oxytetracycline ≤ 0.5%
f) 2-acety-2-decarbamoyldoxycycline ≤ 0.5%
g) any other impurity ≤ 0.5%
10. Ethanol 4.3   ̴ 6.0 % (m/m)
11. Sulphated ash ≤ 0.4%
12. Water 1.4   ̴ 2.8 %
13. Assay 95.0%   ̴ 102.0% (C22H25CIN2O8)
(anhydrous and ethanol-free substance)  

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