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Terbinafine HCL terbinafine hydrochloride 78628-80-5
Terbinafine Hcl(CAS NO.78628-80-5)
1.Name:Terbinafine HCL
2.Assay: 98.5% min
3.White or off-white powder
4.Cas no.: 78628-80-5
5.Standard:EP7.2
Product Name: Terbinafine Hydrochloride |
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Batch No. : 130201TH |
Mfg. Date: 02,Feb,2012 |
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Exp. Date: 01,Feb,2016 |
Net weight: 150KGS |
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Report Date: 07, Feb,2012 |
Standard: EP7.2 |
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Storage: Storage in tight containers, protected from light |
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Analytical Results |
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Items |
Standard |
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 as the same as Terbinafine Hydrochloride CRS B:It gives reaction of chlorides |
A.Complies
B.Complies |
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Related substances
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ImpurityB: NMT0.15% ImpurityE: NMT0.05% Any other impurity: NMT0.1% Total of impurity: NMT0.3 % |
ImpurityB: 0.012% ImpurityE: N.D Any other impurities:0.05% Total of impurities:0.17% |
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Loss on drying |
NMT0.5% |
0.20% |
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Sulphated ash |
NMT0.1% |
0.03% |
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Assay |
99.0% ~ 101% |
99.82% |
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Conclusion: The results shows that the products complies with EP7.2 |
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