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99.8% Pharmaceutical Raw Materials Promethazine HCL With USP Standard

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99.8% Pharmaceutical Raw Materials Promethazine HCL With USP Standard

China 99.8% Pharmaceutical Raw Materials Promethazine HCL With USP Standard supplier
99.8% Pharmaceutical Raw Materials Promethazine HCL With USP Standard supplier 99.8% Pharmaceutical Raw Materials Promethazine HCL With USP Standard supplier

Large Image :  99.8% Pharmaceutical Raw Materials Promethazine HCL With USP Standard

Product Details:

Place of Origin: Wuhan,Hubei
Brand Name: Yuancheng
Certification: ISO9001
Model Number: 58-33-3

Payment & Shipping Terms:

Minimum Order Quantity: 10g
Price: negotiate
Packaging Details: well packed
Delivery Time: 4-7 working days
Payment Terms: T/T, Western Union, MoneyGram,bitocin
Supply Ability: 5000kg/M
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Detailed Product Description
Name: Promethazine Hydrochlorine MF: C17H21ClN2S
MW: 320.88 CAS: 58-33-3
Purity: 99.8% Appearance: White Crystalline Powder
Standard: USP Standard

99.8% Pharmaceutical Raw Material Promethazine HCL With USP Standard

Promethazine Hydrochlorine
MF:C17H21ClN2S
MW: 320.88
CAS:58-33-3
Appearance:white crystalline powder
Purity:99.8%
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.
Dermographism.
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
Standard adopted BP/USP
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
identification    
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
Acidity    
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%
Residual solvents    
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
Conclusion Qualified

 

99.8% Pharmaceutical Raw Materials Promethazine HCL With USP Standard

 

 

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