Customization: | Available |
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CAS No.: | 65-23-6 |
Formula: | C8h11no3HCl |
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Test Item
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Specification
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Result
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Methods
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Appearance
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A white or almost white crystalline powder or granular
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almost White crystalline powder
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Visual
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Identification
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(1)should be positive reaction
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(1)positive reaction
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USP43
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(2)Consistent with the reference IR spectra
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(2)Consistent with the reference IR spectra
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USP43
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PH
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2.4~3.0
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2.7
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USP43
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Appearance of solution
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clear,not more intense than Y7
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clear,not more intense than Y7
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BP2020
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Heavy metals
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NMT10ppm NMT2ppm
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<10 ppm <2 ppm
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USP43
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ICP/MS
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||
Pb Loss on drying
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NMT0.5%
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0.11%
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USP43
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Sulfated ash
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NMTO.10%
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0.04%
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USP43
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Chloride content
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16.9~17.6%
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17.19%
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USP43
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Related substances (Disregard
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limit 0.05%)
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0.04%
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--Total impurities
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NMT0.20%
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0.01%
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BP2020
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- -Unspecified impurities
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NMT0.10%
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BP2020
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- -B impurity
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NMT0.15%
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0.02%
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BP2020
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Assay
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99.0~101.0%
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99.73%
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BP2020
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Microbials
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- -S. Aureus - - Salmonella
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Negative Negative
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Negative Negative
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CH.P.2020 CH.P.2020
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CH.P.2020
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- -E.Coli
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Negative
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Negative <1000cfu/g
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- -Total Plate Count
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NMT1000cfu/g
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CH.P.2020
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- -Yeast and Mold
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NMT100cfu/g
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<100cfu/g
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CH.P.2020
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Conclusion:This batch complies with the specification of BP2020/USP43/FCC11
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