Japan Released Amendment of Standard for Quasi Drug Ingredients 2006

  •   18 Apr 2017
  •    Jo Zhou

    Take home:

    Japan MHLW revised its overall standards for raw ingredients used in quasi drug on Mar 30, 2017. The amendment mainly refers to general testing methods changing of some items and quality standard modification of several ingredients

    This amendments of Standards will be effective on Sep 30th 2018, and before this date, there will a grace period.

    Modifications in Part 1(generally about method):

    No.

    Items

    1.

    Amine value measurement method

    2.

    Titanium Dioxide Determination Method

    3.

    PH testing method

    4.

    Arsenic testing method

    5.

    Vitamin A quantification method

    6.

    Powder X-ray diffraction testing method

    7.

    Methanol testing method

    8.

    Iodine value testing method

    9.

    filter Paper Chromatography

    10.

    Standard goods

    11.

    Testing drug& testing liquid

    12.

    Standard liquid for concentration analysis

    13.

    Standard liquid

    Modifications in Part2 (generally about form and quality change of ingredients)

    No.

    Items

    1.

    Ethanol

    2.

    Ethanol 96

    3.

    Hydrolyzed wheat protein solution

    4.

    Hydrolyzed wheat powder

    5.

    Retinol acetate

    6.

    Retinol palmitate

    7.

    Vitamin A oil

    8.

    Polyvinyl chloride dimethyl dimethylene pyrrolidinium solution

    9.

    Absolute ethanol

    10.

    Propylene glycol laurate

     

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