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Oxytetracycline Hydrochloride

MOLECULAR FORMULA: C22H24N2O9.HCl
TEST BASIS: BP2005/EP5.0
index
STANDARD
Typical result
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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