Hangzhou Fuluo Biological Technology Co.,Ltd.
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|Purity:||99.8%||Appearance:||White Crystalline Powder|
99.8% Pharmaceutical Raw Material Promethazine HCL With USP Standard
Appearance:white crystalline powder
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
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 name||Promethazine hydrochloride|
|CAS No.||58-33-3||Outer Packing||25kg/drum|
|Production date||Jan.2016||Shelf life||Dec.2019|
|Items of analysis||Specification||Results|
|Appearance||a white or faintly yellowish crystalline powder||a white crystalline powder|
|solubility||very 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 point||it melts at about 222 ° with decomposition||it 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 Spectrum||the 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|
|B.by TLC||it complies with the identification test for phenothiazines||it complies with the identification test for phenothiazines.|
|C.Test with Nitric Acid||forms orange colored solution and orange red precipitate||forms orange colored solution and orange red precipitate.|
|D.test for chlorides||shall comply the test.||complies with test for chlorides|
|10% w/v solution||4.0-5.0||4.37|
|1 in 20 solution||4.0-5.0||4.62|
|related substance By HPLC|
|impurity A||NMT 0.1%||ND|
|impurity B||NMT 0.8%||0.15%|
|impurity C||NMT 0.2%||0.05%|
|impurity D||NMT 0.1%||ND|
|Unspecified impurity||NMT 0.1%||0.02%|
|total impurities||NMT 1.2%||0.22%|
|related substance by TLC(as per USP)|
|single impurity||NMT 1.0%||0.25%|
|sum of impurities||NMT 2.0%||0.45%|
|heavy metals||NMT 10 ppm||less than 10 ppm|
|loss on drying at 105℃||NMT 0.5% w/w||0.16%|
|sulphate ash||NMT 0.1% w/w||0.01%|
|assay||99%-101% w/w as per BP;97%-101.5% w/w as per USP||99.80%|
|class 1 solvents||-----||not used in our mfg.process|
|class 2 solvents o-xylene||ICH Limits:2170ppm||813 ppm|
|class 3 solvents Isopropyl alcohol||ICH Limits:5000ppm||362 ppm|