Product name: Doxycycline HCL
1.Formular: C22H25CIN2O8
2.CAS #: 10592-13-9
3.Purity: 99% min
CERTIFICATE OF ANALYSIS
|
DESCRIPTION OF GOODS |
Doxycycline Hyclate |
|
|
BATCH NO. |
K9-020 |
|
|
MANUFACTURING DATE |
FEB.03.2009 |
|
|
EXPIRY DATE |
Jan.2013 |
|
|
QUANTITY |
1001kgs |
|
|
COUNTRY OF ORIGIN |
CHINA |
|
|
NAME OF INDEX |
INDEX |
ANALYSIS VALUE |
|
Characteristics |
A yellow crystalline powder |
Comply |
|
Solubility |
Complies to PH.Eur.6.0 |
Comply |
|
Identification |
A.B.C.Positive reaction |
Comply |
|
p.h |
2.0-3.0 |
2.4 |
|
Absorbance (349 nm) |
300-335 |
321 |
|
Specific optical rotation |
-105~-120° |
-116° |
|
Heavy metals |
≤50ppm |
<50ppm |
|
Light—absorbing impurities(490nm) |
≤0.07 |
0.02 |
|
Impurity A Impurity C Impurity D Impurity E Impurity F Any other impurity |
≤2.0% ≤0.5% ≤0.5% ≤0.5% ≤0.5% ≤0.5% ≤0.10 |
Comply |
|
Ethanol |
4.3- 6.0% |
4.6% |
|
Sulphated ash |
≤0.4% |
0.03% |
|
Water |
1.4-2.8% |
2.0% |
|
Microbial limit |
Total aerobic microbial count≤1000CFU/g |
Comply |
|
Assay: 95.0%--102.0% of Doxycycline hydrochloride (C22H25CIN2O8). calculated with reference to the anhydrous, ethanol-free substance. |
97.5% |
|
|
CONCLUSION: Complies with Ph.Eur.6.0 . (NO.RO-CEP 2001-038-Rev01) |
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