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Basic Info
  • Grade: food grade, pharmaceutical grade

    Factory Location: Hunan, China (Mainland)

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa

  • Sample Provided: no

    Payment Terms: T/T,L/C,DP,BANK CONTRACT

     

    Items

    Specifications

    Results

    Appearance

    A white or almost white powder

    Conforms

    Solubility

    Soluble in water and in ethanol (96%)

    Conforms

    Identification

     

    A

    Melting point : 163°C~166°C

    164.0~164.5°C

    B

    Examine by infrared absorption spectrophotometry, comparing with the spectrum obtained with propranolol hydrochloride CRS.

    Conforms

    C

    Examine by thin-layer chromatography. The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution.

    Conforms

    D

    It gives reaction(a) of chlorides

    Conforms

    Tests

     

    Appearance of solution

    The solution is clear and not more intensely coloured than intensity 6 of the range of reference solutions of the most appropriate colour

    Conforms

    Acidity or alkalinity

    Add 0.1ml of methyl red solution R and 0.2 ml of 0.01M hydrochloric acid, the solution is red. Add 0.4ml of 0.01 M sodium hydroxide. The solution is yellow.

    Conforms

    Related substances

    Any impurity NMT 0.1%

    0.03%

     

    The sum of all impurities NMT 0.4%

    0.21%

    Heavy metals

    NMT 20ppm

    Conforms

    Loss on drying

    NMT 0.5%

    0.11%

    Sulphated ash

    NMT 0.1%

    0.08%

    Residual solvents

    A: ethanol: NMT 5000ppm

    B: Xylene: NMT 2170ppm

    Conforms

    Conforms

    Assay

    99.0%~101.0%

    99.3%

    Conclusion: conform to EP7.0

     

     

     

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