SHANGHAI FINE CHEMICALS CO., LTD.
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TEST
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SPECIFICATION
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- Solubility
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Freely soluble in water, slightly soluble in alcohol 96%v/v.
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- Description
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White to yellowish powder.
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- Identification
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Complies test EP Ed 6.8.
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- Appearance of the Solution
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Complies test EP Ed 6.8.
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- pH
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Between 2.4 and 3.0 (EP Ed 6.8)
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- Related substances
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Impurity B: NMT 0.15%
Unknown individual impurities: NMT 0.10%
Total impurities: NMT 0.2%
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- Loss on drying:
- Residue on ignition:
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NMT 0.5 % (EP Ed 6.8).
NMT 0.1 % (EP Ed 6.8).
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- Heavy Metals:
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Max. 20 ppm (EP Ed 6.8).
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- Particle size:
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Pass mesh 1400 µm: NLT 95%. Pass mesh 150 µm: NLT 35%.
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- Assay (HPLC):
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Between 96.0% and 99.0 % on dried basis (EP Ed 6.8).
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CPHI in Shanghai,China. JUNE 24-26, 2015,Booth No.W1A38 |
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