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CAS NO.64-75-5
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Tetracycline Hydrochloride 64-75-5
Item | Standard | Result | ||||
Characteristics | A white or yellowish white powder .Odorless or almost.bygroscopic | Conforms | ||||
Identification | A:B:C The positive reaction. | Conforms | ||||
Solubility | Very soluble in water, insoluble in acetone , chloroform, ether. | Conforms | ||||
Specific optical rotation | +53.5°~ +59.0° | +58.0° | ||||
Acidity of alkalinity | 5.0~7.5 | 6.7 | ||||
Impurity A | 2%max | Conforms | ||||
Impurity C | 3% ~15% | Conforms | ||||
Any other impurity | not more than the area of the principal peak | Conforms | ||||
in the chromatogram obtained with RS(B)5% | ||||||
Total other impurity | not more than 3times the area of the principal peak | Conforms | ||||
in the chromatogram obtained with RS(B)15% | ||||||
Disregard limit | ae of the principal peak in the chromatogram | Conforms | ||||
obtained with RS(C)1% | ||||||
Loss on drying (pct) | max8.0 | 5.0% | ||||
Sulphate | 27.0-31.0% | 28.4%max | ||||
Sulphated ash | 1% max | 0.2% | ||||
Microcount limit test | NMT 500 col/g | 10 col/g | ||||
Microcount-yeast and molds | NMT 10 col/g | Conforms | ||||
Microcount-Escherichia coli | Absent | Conforms | ||||
Microcount-Staphy lococcus aureus | Absent | Conforms | ||||
Microcount-Pseudo monas | Absent | |||||
Assay | ≥680I.U./mg (DRY) | 687I.U./mg DRY 653I.U./mg MOIST |