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Test |
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Specification |
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Description |
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Faintly yellowish to light Yellowish Crystalline Powder |
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Solubilit |
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Soluble in Water, slightly soluble in Acetic Acid & in Methanol, very Slightly
Soluble in Ethanol, Practically insoluble in Acetone, Acetonitrile,Ethyl
Acetate, Hexana and in methylene chlorideldentification |
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1) By infrared Spectrophotometer |
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1) The Infrared absorption spectrum of sample should be concordant with the working standard. |
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2) TLC |
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2) Compare with reference standard. |
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pH of 2.5% w/v solution in Water |
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Between 3.00-4.50 |
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Water (by KF) |
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Between 4.70 % and 6.70% w/w |
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Sulphated Ash |
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Not more than 0.10% w/w |
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Sulphates |
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Not more than 0.04% w/w |
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Heavy Metals |
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Not more than 0.002% w/w |
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Fluoroquinolonic Acid |
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Not more than 0.20% w/w |
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Relative Substances by HPLC |
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HPLC Puroty |
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Ethylene Diamine Analog |
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Individual Impurity |
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Sum of impurities |
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Not Less Than 99.50% |
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Not Less Than 0.50% w/w |
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Not Less Than 1.00% w/w |
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Not Less Than 0.50% w/w |
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Assay ( on dry basis) |
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Between 98.00% to 102.00% |
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IN HOUSE TEST |
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|
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UV of 2.5% W/V solution |
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NMT 0.05Abs |
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In water at 450ml |
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Bulk density (Tapped)
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0.30 to 0.50gr/ml |
