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High Quality USP/EP/BP GMP DMF FDA Sumatriptan Tablets CAS NO 103628-46-2 Producer

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Price: $ 0.08 / Tablet
Quantity:
min order: 1 Tablet
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ350
  • Dideu
  • 103628-46-2
  • C14H21N3O2S
  • China
  • Sumatriptan 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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Sumatriptan Tablets 

Action and use

Serotonin 5HT1 receptor agonist; treatment of migraine.

Definition

Sumatriptan Tablets contain Sumatriptan Succinate.

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

Content of sumatriptan succinate, C14H21N3O2S,C4H6O4

95.0  to 105.0% of the stated amount.
Identification

Add 10 ml of methanol to a quantity of powdered tablets containing 0.1  g of Sumatriptan Succinate, mix with the aid of ultrasound for 5 minutes, filter through a 0.4-µm PTFE filter, evaporate the filtrate and dry under reduced pressure for 1 hour. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of sumatriptan succinate (RS 413).

Tests

Impurities A and H

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


(1)  Add 100 ml of 0.1m hydrochloric acid to a quantity of the powdered tablets containing 0.2 g of Sumatriptan Succinate, mix with the aid of ultrasound and filter through a 0.4-µm PTFE filter. 

(2)  Dilute 1  volume of solution (1) to 100  volumes with 0.1m hydrochloric acid and dilute 3  volumes of the resulting solution to 4  volumes with the same solvent. 

(3)  Dilute the contents of a vial of sumatriptan for system suitability EPCRS (containing impurities A and H) to 1 ml with 0.1m hydrochloric acid.


chromatographic conditions

(a)  Use a stainless steel column (25  cm x 4.6  mm) packed with silica gel for chromatography (Spherisorb silica  S5W is suitable).

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

(c)  Use a flow rate of 2.0 ml per minute.

(d)  Use ambient column temperature. 

(e)  Use a detection wavelength of 282 nm.

(f)  Inject 20 µl of each solution.

(g)  For solution (1) allow the chromatography to proceed for 5 times the retention time of the principal peak.


mobile phase

A mixture of 10  volumes of 10m ammonium acetate and 90  volumes of methanol.


system suitability

The test is not valid unless in solution (3): 


— the chromatogram resembles that supplied with sumatriptan for system suitability EPCRS;

— the resolution factor between impurity A and sumatriptan is at least 1.5.

limits 

In the chromatogram obtained with solution (1):


— the area of any peak corresponding to impurity A is not greater than 1.25 times the area of the principal peak in the chromatogram obtained with solution  (2) (0.75% taking into account the correction factor of 0.6);

— the area of any peak corresponding to impurity H is not greater than 0.4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%). 


Related substances 

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


(1)  Add 100 ml of 0.1m hydrochloric acid to a quantity of the powdered tablets containing 0.2 g of Sumatriptan Succinate, mix with the aid of ultrasound and filter through a 0.4-µm PTFE filter. 

(2)  Dilute 3  volumes of solution  (1) to 100  volumes with 0.1m hydrochloric acid and dilute 1 volume of the resulting solution to 10 volumes with 0.1m hydrochloric acid. 

(3)  Dilute the contents of a vial of sumatriptan impurity mixture EPCRS (containing impurities B, C, D and E) to 1 ml with 0.1 m hydrochloric acid. 


chromatographic conditions

(a)  Use a stainless steel column (25  cm x 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5  µm) (Spherisorb ODS  1 is suitable).

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

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

(d)  Use ambient column temperature. 

(e)  Use a detection wavelength of 282 nm.

(f)  Inject 20 µl of each solution.


mobile phase

A mixture of 25 volumes of acetonitrile and 75 volumes of a solution containing 0.97  g of dibutylamine, 0.735  g of orthophosphoric acid and 2.93  g of sodium dihydrogen orthophosphate in 750  ml of water, adjusted to pH 7.5 with 10m sodium hydroxide and diluted to 1000  ml with water.


system suitability

The test is not valid unless in solution (3): 


— the chromatogram resembles that supplied with sumatriptan impurity mixture EPCRS;

— the resolution factor between impurity C and sumatriptan is at least 1.5.

limits 

In the chromatogram obtained with solution (1):


— the area of any peaks corresponding to impurities B, C and D are not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.75%);

— the area of impurity E and any other secondary peak is not greater than area of the principal peak in the chromatogram obtained with solution (2) (0.3%). 

The total impurity content in the test for Impurities A and H and the test for Related substances is not greater than 2.0%.

Assay

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


(1)  Add 100 ml of 0.1m hydrochloric acid to a quantity of the powdered tablets containing 0.2  g of Sumatriptan Succinate, mix with the aid of ultrasound, filter through a 0.4-µm PTFE filter and dilute 1  volume to 10  volumes with 0.1m hydrochloric acid. 

(2)  0.02%  w/v of sumatriptan succinate EPCRS in 0.1m hydrochloric acid. For solution (3) dilute the contents of a vial of sumatriptan impurity mixture EPCRS containing impurities B, C, D and E to 1 ml with 0.1 m hydrochloric acid. 


chromatographic conditions

The chromatographic procedure described under Related substances may be used. 


system suitability

The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between sumatriptan and impurity C is at least 1.5.


determination of content

Calculate the content of C14H21N3O2S, C4H6O4 in the tablets using the declared content of C14H21N3O2S,C4H6O4 in sumatriptan succinate EPCRS.

Impurities

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




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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