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High Quality USP/EP/BP GMP DMF FDA Sulpiride Tablets CAS NO 15676-16-1 Producer

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  • AZ349
  • Dideu
  • 15676-16-1
  • C15H23N3O4S
  • 239-753-7
  • China
  • Sulpiride 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

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

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Sulpiride Tablets 

Action and use

Dopamine receptor antagonist; neuroleptic.

Definition

Sulpiride Tablets contain Sulpiride.

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

Content of sulpiride, C15H23N3O4S

95.0  to 105.0% of the stated amount.
Identification

To a quantity of the powdered tablets containing 0.2  g of Sulpiride add 20  ml of methanol, shake for 5  minutes, filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of sulpiride (RS 391).

Related substances

A.  Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.


(1)  Add 20  ml of methanol to a quantity of the powdered tablets containing 0.2  g of Sulpiride, shake for 5  minutes, filter, evaporate the filtrate to dryness and dissolve the residue in 10  ml of methanol.

(2)  0.02% w/v of sulpiride impurity  A  EPCRS in methanol.

(3)  Dilute 1  volume of solution (2) to 10  volumes with methanol.


chromatographic conditions

(a)  Use a silica gel  HF254 precoated plate (Analtech Uniplates are suitable).

(b)  Use the mobile phase as described below.

(c)  Apply 10  µl of each solution.

(d)  Develop the plate to 10  cm.

(e)  After removal of the plate, dry in air, spray with ninhydrin solution and heat at 100° to 105° for 15  minutes.


mobile phase

2  volumes of 13.5m ammonia, 10  volumes of 1,4-dioxan, 14  volumes of methanol and 90  volumes of dichloromethane.


limits

Any spot in the chromatogram obtained with solution (1) corresponding to the principal spot in the chromatogram obtained with solution (2) is not more intense than the spot in the chromatogram obtained with solution (3) (0.1%).


B.  Carry out the method for liquid chromatography, Appendix III D, using the following  solutions.


(1)  Add 20  ml of methanol to a quantity of the powdered tablets containing 0.2  g of Sulpiride, shake for 5  minutes, filter, evaporate the filtrate to dryness and dissolve the residue in sufficient of the mobile phase to produce 200  ml.

(2)  Dilute 3  volumes of solution (1) to 100  volumes with the mobile phase and dilute 1  volume of this solution to 10  volumes with the mobile phase.

(3)  0.01% w/v of sulpiride BPCRS and 0.01% w/v of sulpiride impurity B EPCRS in the mobile phase.


chromatographic conditions 

(a)  Use a stainless steel column (25  cm × 4.6  mm) packed with octylsilyl silica gel for chromatography (5 µm) (Zorbax RX C8 is suitable).

(b)  Use isocratic elution and the mobile phase described below.

(c)  Use a flow rate of 1.5  ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 240  nm.

(f)  Inject 20 µl of each solution.

(g)  For solution (1) and solution (2) allow the chromatography to proceed for 2.5  times the retention time of sulpiride.


mobile phase 

10  volumes of acetonitrile, 10  volumes of methanol and 80  volumes of a solution containing 6.8% w/v of potassium dihydrogen orthophosphate and 0.1% w/v of sodium octanesulphonate, adjusted to pH 3.3 using orthophosphoric acid.


system suitability 

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 2.5.


limits 

In the chromatogram obtained with solution (1):


the sum of the areas of any secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.3%).


Assay

Weigh and powder 20  tablets. Mix a quantity of the powder containing 0.1  g of Sulpiride with about 50  ml of 0.1m sodium hydroxide for 5  minutes with the aid of ultrasound, add sufficient 0.1m sodium hydroxide to produce 100  ml and filter, discarding the first 10  ml of filtrate. Dilute 5  ml of the filtrate to 100  ml with 0.1m sodium hydroxide and measure the absorbance of the solution at the maximum at 291  nm, Appendix II B, using 0.1m sodium hydroxide in the reference cell. Calculate the content of C15H23N3O4S in the tablets from the absorbance of a 0.005% w/v solution of sulpiride BPCRS in 0.1m sodium hydroxide using the declared content of C15H23N3O4S in sulpiride BPCRS.

Impurities

The impurities limited by the requirements of this monograph include those listed under Sulpiride.




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.

2316

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.


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.


Dideu Industries is one of the largest producer for general chemical, pharmaceutical, nutrition additive, natural extracts, agrochemical and Daily-Use Chemical in China and is headquartered in Shaanxi, China. The Dideu Group comprises subsidiaries and joint ventures in more than 10 countries and operates six integrated production sites and 21 other production sites in Europe, Asia, Australia, Americas and Africa.Its headquarters is located in Xi’An,China. Dideu has customers in over 200 countries and supplies products to a wide variety of industries.


At the end of 2014, the company employed more than 13000 people. In 2014, Group Dideu posted sales of 30 billion and income from operations before special items of about 7.5 billion. The company is currently expanding its international activities with a particular focus on Asia countries. Between 1990 and 2005, the company invested 5.2 billion in Asia, for example in sites near Guangxi,Yunnan, Sichuan, Shaanxi China,Mangalore in India,Bangkok, Thailand,Hanoi, Vietnam etc.


Dideu Industries Consist Of Five Industry Chains:


I)Pharmaceutical Industries

II)Nutrition Additive Industries

III)Daily-Use Chemical Products Industries & Agrochemicals

IV)Environmental Friendly Chemical And Chemurgy Industries

V)Petrochemical Industries

VI)General Chemical Industry


At Dideu, we redefine chemistry to make the world better - and have been doing so for 75 years. As one of the world's leading chemical company, we combine economic success with environmental protection and social responsibility.Through science and innovation we enable our customers in nearly every industry to meet the current and future needs of society.


At Dideu, we create chemistry for a sustainable future with science for a better life.Dideu is a Life Science company with a long and glorious history and core competencies in the areas of health care and agriculture. With our innovative products, we are contributing to finding solutions to some of the major challenges of our time. The growing and increasingly aging world population requires improved medical care and an adequate supply of food. Dideu is improving people's quality of life by preventing, alleviating and treating diseases. And we are helping to provide a reliable supply of high quality food, feed and plant based raw materials.We develop new molecules for use in innovative products and solutions to improve health. Our research and development activities are based on a profound understanding of the biochemical processes in living organisms.Our goal is to achieve and sustain leadership positions in our markets, thus creating value for our customers, stockholders and employees. To this end, our strategy is designed to help solve some of the most pressing challenges facing humankind, and by doing this exceptionally well we aim to strengthen the company's earning power. 


We are committed to operating sustainably and addressing our social and ethical responsibilities as a corporate citizen, while at the same time respecting the interests of all our stakeholders. Employees with a passion for innovation enjoy excellent development opportunities at Dideu.Exclusive Focus on the Life Science BusinessesFollowing the economic and legal independence of our former Material Science subgroup.Dideu has charted the course for its successful development as a Life Science company. Our Life Science businesses hold leading positions in innovation driven growth markets. Together they make up a strong, attractive and balanced portfolio that is resistant to fluctuations in demand and to potential risks.The previous structure comprising a strategic management holding company and operational subgroups has thus been replaced by an integrated organization under the umbrella of the strong Dideu brand. The company's operations are managed in three divisions Pharmaceuticals, Consumer Health and Crop Science and the Animal Health business unit.The business continues to be supported by the corporate functions, Dideu Business Services and the service company Currenta, while Technology Services is being integrated into Dideu Group, forming the Engineering and Technology function.


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