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Product Name |
Terbinafine hydrochloride |
Batch No. |
20181202 |
|
MFG. Date |
Dec 17,2018 |
Exp. Date |
Dec 16,2021 |
|
Quantity |
10g |
Standard |
EP7.0 |
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ITEMS |
SPECIFICATIONS |
RESULTS |
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Appearance |
White or almost white powder |
Complies |
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Solubility |
Very slightly or slightly soluble in water , freely soluble in anhydrous ethanol and in methanol , slightly soluble in acetone |
Complies |
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Identification |
A: IR the infrared absorption spectrum exhibits maximam only at the same wavelengths as that of the standard sample B: It gives reaction of Chlorides |
Complies |
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Related Substances |
A: impurity B NMT 0.1% B: any other impurity NMT 0.1% C: total of impurities NMT 0.3% |
0.004% Complies 0.08% |
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Loss on drying |
＜0.5% |
0.19% |
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Sulphated ash |
＜0.1% |
0.02% |
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Assay |
99.0～101.0%（dried substance） |
99.83% |
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Conclusion |
All analytical methods and results conform to the requirement of EP7.0 |
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