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Oxytetracycline Hydrochloride |
MOLECULAR FORMULA: C22H24N2O9.HCl TEST BASIS: BP2005/EP5.0
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CHARACTERS |
A YELLOW CRYSTALLINE POWDER |
A YELOW CRYSTALLINE POWDER |
FREELY SOLUBLE IN WATER ,SAPARINGLY SOLULE IN ALCHOL |
FREELY SOLUBLE IN WATER ,SAPARINGLY SOLULE IN ALCHOL |
PH |
2.3-2.9 |
2.5 |
SPECIFIC OPTICAL ROTATION |
-188°TO-200° |
-190° |
SPECIFIC ABSORBANCE |
270 TO 290 |
279 |
LIGHT-ABSORBING IMPURITIES |
430nm A≤0.50 |
0.28 |
490nm A≤0.20 |
0.04 |
RELATED SUBSTANCES |
IMPURITY A,NOT MORE THAN 0.5% |
0.4% |
IMPURITY B,NOT MORE THAN 2.0% |
0.7% |
IMPURITY C,NOT MORE THAN 2.0% |
1.1% |
TOTAL IMPURITY OF D,E,F,NOT MORE THAN 0.1% |
NO DETECTED |
HEAVY METALS |
≤50PPM |
<50PPM |
SULPHATED ASH |
≤0.5% |
0.03% |
WATER |
≤2.0% |
0.3% |
RESIDUAL METHANOL |
≤3000PPM |
2038PPM |
ASSAY |
95.0 TO 102.0% |
96.5% |
CONCLUSION |
THIS ABOVE CERTIFICATE OF ANALYSIS COMPLIES WITH BP2004/EP5.0 | | |
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