Product Details
Doxycycline Hcl is antibacterial spectrum is very close to Tetracycline and Terramycin, but it has better effect, be sensitive to the Staphylococcus Aureus of tetracycline-resistant, oxytetracycline, long lasting time.It is often used in Senile Chronic Bronchitis, respiratory tract infection, lung infection, acute tonsillitis, mycoplasma pneumonia, urinary tract infection, blood poisoning, bacillary dysentery, acute lymphadenitis, etc. It is very popular to Nephropathy patient because of its unobvious poisoning for kidney.
|
Items |
Specifications |
Results |
|
Appearance |
Yellow crystalline powder |
Conforms |
|
Identification |
TLC |
Conforms |
|
sulphuric acid reaction a yellow colour develops |
Conforms |
|
|
it gives reaction of chlorides |
Conforms |
|
|
PH |
2.0~3.0 |
2.3 |
|
Specific absorbance |
at 349nm e(1%) 300~355 |
320 |
|
Specific optical rotation |
-105 ~ -120° |
-110° |
|
Heavy metals: |
≤50ppm |
< 20ppm |
|
Light-absorbing impurities |
at 490nm ≤0.07 |
0.03 |
|
Related substances |
6-epidoxycycline ≤2.0% metacycline ≤2.0% 4-epidoxycycline ≤0.5% (ep5) 4-epi-6-epidoxycycline ≤0.5% (ep5) oxytetracycline ≤0.5% (ep5) any other impurity ≤0.5% not identified impurities ≤0.1% (ep5) |
1.6% 0.1% Not found Not found Not found Not found Not found |
|
Ethanol |
4.3~6.0% (m/m) |
4.5% |
|
Sulphated ash |
≤0.4% |
0.05% |
|
Water |
1.4~2.8% |
1.8% |
|
Assay |
95.0~102.0% ( c22h25cln2o8) based on anhydrous, ethanol-free substance |
98.6% |
|
Conclusion |
Conform with USP32 |
|
