DOXYCYCLINE HCL(doxycycline Hyclate) 24390-14-5 C22H25ClN2O8
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Test Carried Out |
Limits |
Observations |
Analysis Result |
Characteristies |
A yellow crystalline powder |
A yellow crystalline powder |
Complies |
Solubility |
Conforms to Pb. Eur.5.0 |
Meet the requirements |
Complies |
Identification |
A.B.C.Positive reaction |
Meet the requirements |
Complies |
PH |
2.0 ~3.0 |
2.4 |
Complies |
Absorbance |
300 ~ 335 |
322 |
Complies |
Specific optical rotation |
- 105 ~ - 120° |
-111° |
Complies |
Heavy metals |
≤50ppm |
<20ppm |
Complies |
Light-absorbing impurities |
≤0.07 |
0.03 |
Complies |
Metacycline 6-epidoxycycline Any Individual impurities Disregard limit |
≤ 2.0% ≤2.0% ≤0.5% ≤0.1 |
conforms |
Complies |
Ethanol |
4.3 – 6.0% |
4.8% |
Complies |
Sulphated ash |
≤0.4% |
<0.1% |
Complies |
Water |
1.4 –2.8% |
2.1% |
Complies |
ASSAY: It contains not loss than 95.0per cent and not more than 102.0 per cent of Doxycycline hydrochloride (C22H25CIN2On)calculated with reference to the anhydrous,othanol-free substance |
98.3% |
Complies |
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