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High Quality USP/EP/BP GMP DMF FDA Chlorpromazine Tablets CAS NO 50-53-3 Producer

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  • AZ056
  • Dideu
  • 50-53-3
  • C17H19ClN2S
  • 200-045-8
  • China
  • Chlorpromazine Tablets
  • High quality
  • 99.0% Min
  • 99%-101%
  • Tablet
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

High Quality USP/EP/BP GMP DMF FDA Chlorpromazine Tablets CAS NO 50-53-3 Producer

Product_Description_title


Our Reference Specification, for more details, pls contact us for COA, MSDS and certification:

Email & Skype: Service@dideu.com Telephone:+86-29-89586680

Mobile:+86-15129568250; Whatsapp&Wechat: +8615129568250


Specification_title

Item Standard Test Results
Identification A.H-NMR:Comply with the structure Complies
B.LC-MS:Comply with the structure Complies
C.The IR spectrum of sample should be identical with that of reference standard. Complies
D.HPLC-ESI-MS Complies
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Loss on drying ≤2.0% 0.19%
Heavy metals ≤10 ppm <10ppm
Water ≤1.0% 0.10%
Sulphated ash ≤0.5% determined on 1.0 g. 0.01%
Residue on ignition ≤0.1% 0.03%
Related Substances Unspecified impurities: for each impurity ≤0.10% <0.10%
Total Impurity ≤0.5% 0.18%
Purity ≥99.0% 99.70%
Assay 99.0%~101.0% (anhydrous substance). 99.80%
Storage Preserve in well-closed, light-resistant and airtight containers. Complies





Our Reference Specification, for more details, pls contact us for COA,MSDS and certification:

Email & Skype: support@dideu.com  Telephone:+86-29-89586682

Mobile:+86-15129568250; Whatsapp: +8615129568250

Chlorpromazine Tablets

Action and use Dopamine receptor antagonist; neuroleptic.

Definition

Chlorpromazine Tablets contain Chlorpromazine Hydrochloride. They are coated.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of chlorpromazine hydrochloride, C17H19ClN2S,HCl 92.5  to 107.5% of the stated amount.
Identification

A.  To a quantity of the powdered tablets containing 40  mg of Chlorpromazine Hydrochloride add 10  ml of water and 2  ml of 10m sodium hydroxide. Shake and extract with 15  ml of ether. Wash the ether layer with two 5  ml quantities of water, dry with anhydrous sodium sulphate and evaporate the ether. Dissolve the residue in 0.4  ml of chloroform. The infrared absorption spectrum of the resulting solution, Appendix II A, is concordant with the reference spectrum of chlorpromazine (RS 056).

B.  Comply with the test for identification of phenothiazines, Appendix III A. For solution (1) shake a quantity of the powdered tablets with sufficient chloroform to produce a solution containing 0.20% w/v of Chlorpromazine Hydrochloride, centrifuge and use the supernatant liquid.

Tests

Related substances

Comply with the test for related substances in phenothiazines, Appendix III A, using mobile phase A and the following freshly prepared solutions. For solution (1) extract a quantity of the powdered tablets containing 0.1  g of Chlorpromazine Hydrochloride with 10  ml of a mixture of 95  volumes of methanol and 5  volumes of diethylamine and filter. For solution (2) dilute 1  volume of solution (1) to 200  volumes with the same solvent mixture.


Dissolution

Carry out the procedure protected from light. Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.


test conditions

(a)  Use Apparatus 2, rotating the paddle at 50 revolutions per minute.

(b)  Use 900 ml of 0.1m hydrochloric acid, at a temperature of 37°, as the medium.


procedure 

(1)  After 45 minutes withdraw a 10 ml sample of the medium and measure the absorbance of the filtered sample, suitably diluted with the dissolution medium to produce a solution containing 0.0005% % w/v of Chlorpromazine Hydrochloride, at the maximum at 254 nm, Appendix II B using 0.1m hydrochloric acid in the reference cell.


determination of content 

Calculate the total content of C17H19ClN2S,HCl, in the medium taking 914 as the value of A(1%, 1  cm) at the maximum at 254  nm.

Assay

Carry out the following procedure protected from light. Powder 10  tablets without loss, triturate the powder with 10  ml of absolute ethanol, add about 300  ml of 0.1m hydrochloric acid and shake for 15  minutes. Add sufficient 0.1m hydrochloric acid to produce 500  ml, filter, dilute a volume of the filtrate containing 5  mg of Chlorpromazine Hydrochloride to 100  ml with 0.1m hydrochloric acid and further dilute 10  ml to 100  ml with the same solvent. Measure the absorbance of the resulting solution at the maximum at 254  nm, Appendix II B. Calculate the content of C17H19ClN2S,HCl taking 915 as the value of A(1%, 1  cm) at the maximum at 254  nm.




Packaging&Shipping_title


Our normal packaging is 25kgs/Drum and 200kgs/Drum.

The packaging can be customized. the shipping term can be by sea, by air, and sample or small quantity can be shipped by DHL, FEDEX, EMS and TNT.

Packaging_title

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Shipping_title

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Payment_Terms_title

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Our_Services_title

a) Free sample can be supplied.

b) Guide our clients by professional knowledge and teach them how to use our product after sales.

c) Accept SGS, BV any other third-party inspection before loading.

d) High quality best price Guaranteed.

Our_Services






FAQ_title


Why do you choose Dideu Industries as your partner?

A) High quality can be guaranteed. Dideu Industries since 1975 are reputed chemical manufacturer and are Certified by ISO 9001;2015 and have GMP certification.Free sample can be arranged before shipment and SGS,BV and other third party inspection company are accepted before loading.For regular customers, we accept L/C 180 Days, D/P,D/A payment term. If there is any quality problem after goods arrive. Dideu Industries will do fully payment refund.

B) Best price can be guaranteed. As Dideu Industries are integrated pharmaceuticals and chemicals producer, the production cost can be controlled and price will be definitely more competitive than China trading companies.

C) Professional enginners from Dideu Industries will give professional usage guide and services after sales.

D) Dideu Industries work 7×24 hours and your request will be processed by our professional staff in different shift period.







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