Hubei Honest Biochemical Co., Ltd.

Product Name: Promethazine hydrochlorine

Other Name: Promethazine HCl

Chemcial Name: N,N-dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine

CAS: 58-33-3

MF: C17H21ClN2S

MW: 320.88

EINECS: 200-375-2

Assay: 99%min

Appearence: White powder

Purpose: This product is used for skin and mucosa irritation, allergic rhinitis, asthma, food allergies, skin scratch disease, motion sickness, airsickness etc..

Package:25kg/drum.

Promethazine HCl COA

Items of analysis Specification Results

description a white or faintly yellowish,crystalline powder a white crystalline powder

solubility very soluble in water,freely soluble in chloroform and in ethanol(95%),practically insoluble in ether very soluble in water,freely soluble in chloroform and in ethanol(95%);practically insoluble in ether

identification  

A. IR absorption spectrum the positions and relative sizes of the banks in the spectrum of the sample and reference spectrum shall be concordant the positions 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 phenothiazine

C.Test with nitric acid forms orange colored solution and organge-red precipitate forms orange colored solution and organge-red precipitate

D.test for chlorides shall comply the test complies with test for chlorides

pH(10% w/v solution) 4.0-5.0 4.31

related substances(by TLC)  

isopromethazine not more than 1.0% less than 1.0%

other impurity not more than 0.5% less than 0.5%

sulphated ash not more than 0.5% 0.20%

loss on drying at 105ºC not more than 0.5% 0.20%

assay(by potentiometric titration) 98.5-101%(on anhydrous basis) 100.0%

Conclusion Qualified