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99.8% Pharmaceutical Raw Materials Promethazine HCL With USP Standard

Categories Pharmaceutical Raw Materials
Brand Name: Yuancheng
Model Number: 58-33-3
Certification: ISO9001
Place of Origin: Wuhan,Hubei
MOQ: 10g
Price: negotiate
Payment Terms: T/T, Western Union, MoneyGram,bitocin
Supply Ability: 5000kg/M
Delivery Time: 4-7 working days
Packaging Details: well packed
name: Promethazine Hydrochlorine
MF: C17H21ClN2S
MW: 320.88
CAS: 58-33-3
Purity: 99.8%
Appearance: white crystalline powder
Standard: USP standard
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    99.8% Pharmaceutical Raw Materials Promethazine HCL With USP Standard

    99.8% Pharmaceutical Raw Material Promethazine HCL With USP Standard

    Promethazine Hydrochlorine
    MW: 320.88
    Appearance:white crystalline powder
    Standard:USP standard

    Promethazine hydrochloride is a phenothiazine used to treat or prevent nausea and vomiting caused by anesthesia or surgery, certain types of allergic reactions, pain caused by surgery or childbirth, and to sedate patients before surgery or medical procedures.

    Promethazine hydrochloride are useful for:
    Perennial and seasonal allergic rhinitis
    Vasomotor rhinitis.
    Allergic conjunctivitis due to inhalant allergens and foods.
    Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
    Amelioration of allergic reactions to blood or plasma.
    Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.
    Preoperative, postoperative, or obstetric sedation.
    Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
    Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.
    Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.
    Active and prophylactic treatment of motion sickness.
    Antiemetic therapy in postoperative patients.

    The COA of Promethazine hydrochloride:

    Product namePromethazine hydrochloride
    CAS No.58-33-3Outer Packing25kg/drum
    Production dateJan.2016Shelf lifeDec.2019
    Standard adoptedBP/USP
    Items of analysisSpecificationResults
    Appearancea white or faintly yellowish crystalline powdera white crystalline powder
    solubilityvery soluble in water,freely soluble in alcohol and in methylene chloride.freely soluble in hot dehydrated alcohol and in chloroform.practically insoluble in ether,in acetone and in ethyl acetate.complies
    melting pointit melts at about 222 ° with decompositionit melts at about 222.4° with decomposition
    completeness and clarity of solution(10% in water)(10% in chlorofrom)shall be practically clear and not more than a light yellow color.clear and colorless
    A.By IR Spectrumthe position and relative sizes of the bands in the spectrum of the sample and reference spectrum shall be concordant.the position and relative sizes of the bands in the spectrum of the sample and reference spectrum are concordant TLCit complies with the identification test for phenothiazinesit complies with the identification test for phenothiazines.
    C.Test with Nitric Acidforms orange colored solution and orange red precipitateforms orange colored solution and orange red precipitate.
    D.test for chloridesshall comply the test.complies with test for chlorides
    10% w/v solution4.0-5.04.37
    1 in 20 solution4.0-5.04.62
    related substance By HPLC
    impurity ANMT 0.1%ND
    impurity BNMT 0.8%0.15%
    impurity CNMT 0.2%0.05%
    impurity DNMT 0.1%ND
    Unspecified impurityNMT 0.1%0.02%
    total impuritiesNMT 1.2%0.22%
    related substance by TLC(as per USP)
    single impurityNMT 1.0%0.25%
    sum of impuritiesNMT 2.0%0.45%
    heavy metalsNMT 10 ppmless than 10 ppm
    loss on drying at 105℃NMT 0.5% w/w0.16%
    sulphate ashNMT 0.1% w/w0.01%
    assay99%-101% w/w as per BP;97%-101.5% w/w as per USP99.80%
    Residual solvents
    class 1 solvents-----not used in our mfg.process
    class 2 solvents o-xyleneICH Limits:2170ppm813 ppm
    class 3 solvents Isopropyl alcoholICH Limits:5000ppm362 ppm

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