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High Quality USP/EP/BP GMP DMF FDA Flecainide Tablets CAS NO 54143-55-4 Producer

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Price: $ 0.08 / Tablet
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  • AZ157
  • Dideu
  • 54143-55-4
  • C17H20F6N2O3
  • 685-650-9
  • China
  • Flecainide 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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Flecainide Tablets 

Action and use

Class I antiarrhythmic.

Definition

Flecainide Tablets contain Flecainide Acetate.

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

Content of flecainide acetate, C17H20F6N2O3,C2H4O2

95.0  to 105.0% of the stated amount.
Identification

A.  The light absorption, Appendix II B, of the solution obtained in the Assay in the range 230  nm to 350  nm exhibits a maximum at 296  nm.

B.  Shake a quantity of the powdered tablets containing 0.1  g of flecainide acetate with 10  ml of 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 flecainide acetate (RS 397).

Tests

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 0.1m hydrochloric acid and rotate the paddle at 100 revolutions per minute. Withdraw a sample of 5  ml of the medium, filter and dilute the filtered solution, if necessary, with sufficient 0.1m hydrochloric acid to produce a solution expected to contain about 0.005% w/v of flecainide acetate. Measure the absorbance of the solution at the maximum at 298  nm, Appendix II B, using 0.1m hydrochloric acid in the reference cell. Calculate the total content of flecainide acetate, C17H20F6N2O3,C2H4O2, in the medium from the absorbance of a 0.005% w/v solution of flecainide acetate BPCRS in 0.1m hydrochloric acid using the declared content of C17H20F6N2O3,C2H4O2 in flecainide acetate BPCRS.


Related substances

Carry out the method for thin-layer chromatography, Appendix III A, using a TLC silica gel F254 plate (Merck plates are suitable) and a mixture of 2  volumes of methanol, 5  volumes of 18m ammonia, 100  volumes of acetone and 100  volumes of dichloromethane as the mobile phase but allowing the solvent front to ascend 10  cm above the line of application. Apply separately to the plate 1 µl of each of the following solutions. For solution (1) add 2  ml of methanol to a quantity of the powdered tablets containing 0.2  g of flecainide acetate, shake, centrifuge and use the supernatant liquid. Solution (2) contains 0.05% w/v of flecainide acetate BPCRS in methanol. Solution (3) contains 0.05% w/v of flecainide impurity A EPCRS in methanol. Solution (4) contains 0.02% w/v of flecainide impurity B EPCRS in methanol. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254  nm). In the chromatogram obtained with solution (1) any spot corresponding to 3-[2,5-bis(2,2,2-trifluoroethoxy)phenyl]-1,5,6,7,8,8ahexahydroimidazo[1,5-a]pyridine (impurity A) is not more intense than the principal spot in the chromatogram obtained with solution (3) (0.5%). Spray the plate with a freshly prepared 0.2% w/v solution of ninhydrin in absolute ethanol, heat the plate at 105o for approximately 5  minutes and examine immediately. In the chromatogram obtained with solution (1) any bluish-purple spot corresponding to (piperidin-2-yl)methanamine (impurity B) is not more intense than the principal spot in the chromatogram obtained with solution (4) (0.2%) and any other secondary spot is not more intense than the principal spot in the chromatogram obtained with solution (2) (0.5%).

Assay

Shake 20  tablets with 100  ml of a 2% v/v solution of lactic acid until the tablets have disintegrated, add 650  ml of water, shake with the aid of ultrasound for 30  minutes, add sufficient water to produce 1000  ml, mix and filter (Whatman GF/F paper is suitable), discarding the first 100  ml of filtrate. Dilute the filtrate with a 0.2% v/v solution of lactic acid to produce a solution containing 0.01% w/v of flecainide acetate and measure the absorbance of the resulting solution at the maximum at about 296  nm, Appendix II B, using a 0.2% v/v solution of lactic acid in the reference cell. Calculate the content of C17H20F6N2O3,C2H4O2 in the tablets from the absorbance obtained with a solution containing 0.01% w/v of flecainide acetate BPCRS in a 0.2% v/v solution of lactic acid and using the declared content of C17H20F6N2O3,C2H4O2 in flecainide acetate BPCRS.

Storage

Flecainide Tablets should be stored at a temperature not exceeding 30°.

Impurities

The impurities limited by the requirements of this monograph include impurities A, B and D stated under Flecainide Acetate.




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2316

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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.


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I)Pharmaceutical Industries

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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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