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Oxytetracycline HCL
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CERTIFICATE OF ANALYSIS | |||
Name of product:: | Oxytetracycline HCL | ||
According to: | BP2005 | ||
Batch No.: | Y1-0803192-1 | ||
RESULTS OF ANALYSIS TESTS AS FOLLOWS: | |||
ANALYSIS ITEM | QUALITY INDEXES | RESULTS | |
Description | Yellow crystalline powder | Confirm | |
Indentification | a)TLC results b)colour reaction with sulphuric acid c)reaction of chlorides | Positive Positive Positive | |
PH value(1% w/v) | 2.3∼2.9 | 2.32 | |
Absobance at 353nm(PH 2.0) | 270∼290 | 277.5 | |
Specific optical rotation | -188∼-200 | -193.6 | |
Heavy metals | <50ppm | <25 | |
Light absorbing impurities | <0.50(430nm) < 0.20(490nm) | 0.32 0.06 | |
Related substance Impurity A Impurity B Impurity C Impurity D,E and F | <0.5% <2.0% <2.0% <2.0% | 0.2% 0.2% 1.46% 0.55% | |
Sulphated Ash | <0.5% | 0.09% | |
Water content | <2.0% | 0.29% | |
Assay(caulated on anhydrous product) | 95%∼120% | 95.3% | |
Conclusion | This product complies with BP2005 | ||
Oxytetracycline HCL
