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High Quality USP/EP/BP GMP DMF FDA Sulindac Tablets CAS NO 38194-50-2 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
  • AZ348
  • Dideu
  • 38194-50-2
  • C20H17FO3S
  • 253-819-2
  • China
  • Sulindac 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

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Sulindac Tablets 

Action and use

Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.

Definition

Sulindac Tablets contain Sulindac.

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

Content of sulindac, C20H17FO3S

95.0  to 105.0% of the stated amount.
Identification

A.  Shake a quantity of the powdered tablets containing 0.1  g of Sulindac with 10  ml of a mixture of equal volumes of chloroform and methanol for 10  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 sulindac (RS 323).


B.  The light absorption, Appendix II B, in the range 230  to 350  nm of the solution obtained in the Assay exhibits two maxima, at 284  nm and 327  nm, and a less well-defined maximum at 258  nm.


Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using Apparatus 2. Use as the medium 900  ml of phosphate buffer pH 7.2 and rotate the paddle at 50 revolutions per minute. Withdraw a sample of 10  ml of the medium, filter and dilute with phosphate buffer pH 7.2 to give a solution expected to contain 0.001% w/v of Sulindac. Measure the absorbance of this solution, Appendix II B, at 327  nm using phosphate buffer pH 7.2 in the reference cell. Calculate the total content of C20H17FO3S in the medium taking 373 as the value of A(1%, 1  cm) at the maximum at 327  nm.

Tests

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Mix 160  volumes of tetrahydrofuran and 840  volumes of methanol (solution A). Mix equal volumes of solution A and a solution containing 0.358% w/v of disodium hydrogen orthophosphate and 0.34% w/v of tetrabutylammonium hydrogen sulphate (the mixture is solution B). For solution (1) shake a quantity of whole tablets containing 1  g of Sulindac with 175  ml of solution A mechanically for 15  minutes and then with the aid of ultrasound until the tablets have fully disintegrated (at least 15  minutes). Allow the resulting suspension to cool, add sufficient of solution B to produce 200  ml and mix. Dilute 10  ml of the resulting solution to 100  ml with solution B and filter through a 0.45-µm filter (Millipore Millex is suitable). For solution (2) dilute 1  volume of solution (1) to 100  volumes with solution B and further dilute 1  volume to 2  volumes with the same mixture of solvents. Solution (3) contains 0.050% w/v of sulindac EPCRS (which has an assigned content of the E-isomer) in solution B. For solution (4) add 0.05  ml of a 3% w/v solution of potassium permanganate to 5  ml of solution (1) (generation of sulphoxide impurity). For solution (5) add a few granules of zinc, in fine powder to 5  ml of solution (1), add 0.2  ml of hydrochloric acid, mix and filter through a 0.45-µm filter (generation of desoxy impurity). For solution (6) add 0.3  ml of methanol to 5  ml of solution (1), add 0.2  ml of sulphuric acid and mix (generation of methyl ester). For solution (7) add 0.3  ml of absolute ethanol to 5  ml of solution (1), add 0.2  ml of sulphuric acid and mix (generation of ethyl ester).


The chromatographic procedure may be carried out using (a) a stainless steel column (15  cm × 4.6  mm) packed with octylsilyl silica gel for chromatography (5 µm) (Beckman Ultrasphere C8 is suitable), (b) as mobile phases A and B with a flow rate of 2  ml per minute the solutions described below and (c) a detection wavelength of 330  nm. Carry out a linear gradient elution using the following conditions.


Mobile phase A  Mix 160  volumes of tetrahydrofuran and 840  volumes of methanol (solution C). Prepare a solution containing 0.358% w/v of disodium hydrogen orthophosphate and 0.34% w/v of tetrabutylammonium hydrogen sulphate and mix 380  volumes of solution C with 620  volumes of this solution, adjust the pH of the mixture to 6.0 with orthophosphoric acid or a 50% w/v solution of sodium hydroxide, mix with the aid of ultrasound for 10  minutes and filter through a 0.45-µm filter.


Mobile phase B  Acetonitrile.


11021542

Inject 20 µl of solution (3) and continue the chromatography for twice the retention time of the principal peak. The chromatogram obtained shows a principal peak corresponding to sulindac and a peak corresponding to the E-isomer with a retention time relative to sulindac of about 1.25.


From the chromatograms obtained with solution (1) and solution (3) calculate the content of E-isomer in the preparation being examined using the declared content of the E-isomer in sulindac EPCRS; the E-isomer content is not more than 0.5%. In the chromatogram obtained with solution (1), the area of any peaks corresponding to the desoxy impurity, the sulphoxide impurity, the ethyl ester impurity or the methyl ester impurity (identified by reference to the chromatograms obtained with solutions (4) to (7)) are not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%) and the sum of the areas of all the secondary peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (1%).

Assay

Weigh and powder 20  tablets. Shake a quantity of the powdered tablets containing 0.1  g of Sulindac with 80  ml of 0.1m methanolic hydrochloric acid for 10  minutes and dilute to 100  ml with the same solvent. Filter and dilute 3  ml of the filtrate to 200  ml with the same solvent. Measure the absorbance of the resulting solution at the maximum at 327  nm, Appendix II B, and calculate the content of C20H17FO3S taking 373 as the value of A(1%, 1  cm) at the maximum at 327  nm.

Storage

Sulindac Tablets should be protected from light.




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.

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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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