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High Quality USP/EP/BP GMP DMF FDA Terfenadine Oral Suspension CAS NO 50679-08-8 Producer

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  • AZ600
  • Dideu
  • 50679-08-8
  • C32H41NO2
  • 256-710-8
  • China
  • Oral Suspension
  • High quality
  • 99.0% Min
  • 99%-101%
  • Oral Suspension
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

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Terfenadine Oral Suspension 

Action and use

Histamine H1 receptor antagonist; antihistamine.

Definition

Terfenadine Oral Suspension is a suspension of Terfenadine in a suitable flavoured vehicle.

The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements.

Content of terfenadine, C32H41NO2 

95.0  to 105.0% of the stated amount.

Identification

A.  Shake a volume of the suspension containing 60  mg of Terfenadine with 10  ml of water, centrifuge and discard the liquid phase. Shake the residue sequentially with 10  ml of water, 10  ml of 0.2m sodium hydroxide, 10  ml of water and 10  ml of n-hexane, centrifuge and discard the liquid phase after each extraction. Dissolve the residue in 15  ml of dichoromethane, shake with 2  g of anhydrous sodium sulphate and filter. Add 0.5  ml of the filtrate to 0.3  g of potassium bromide in a mortar, mix with a pestle, warm to remove the solvent and prepare a disc from the resulting mixture. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of terfenadine (RS 392).

B.  In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).

1-[4-(1,1-Dimethylethyl)phenyl]-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butan-1one

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) dilute a quantity of the oral suspension containing 30  mg of Terfenadine to 70  ml with the mobile phase, shake for 1  hour, add sufficient mobile phase to produce 100  ml, mix and centrifuge. Solution (2) contains 0.00006% w/v of terfenadine impurity A EPCRS (1-[4-(1,1-dimethylethyl)phenyl]-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butan-1-one) in the mobile phase. Solution (3) contains equal volumes of solution (1) and a solution containing 0.03% w/v of terfenadine impurity A EPCRS in the mobile phase.

The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm × 4.6  mm) packed with end-capped octylsilyl silica gel for chromatography (5 µm) (Lichrosorb RP8 is suitable), (b) 3  volumes of acetonitrile diluted to 5  volumes with diethylammonium phosphate buffer solution pH 6.0 as the mobile phase with a flow rate of 1.0  ml per minute and (c) a detection wavelength of 254  nm.

Inject 20 µl of each solution and continue the chromatography for 5  times the retention time of terfenadine. The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due terfenadine and terfenadine impurity A is at least 5.0.

In the chromatogram obtained with solution (1) the area of any peak corresponding to terfenadine impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%). In the chromatogram obtained with solution (1) peaks due to excipients with long retention times may be present.

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) add about 70  ml of the mobile phase to a weighed quantity of the oral suspension containing 30  mg of Terfenadine and shake for 1  hour. Dilute to 100  ml with the mobile phase, mix, centrifuge and, if necessary, filter the supernatant liquid. Solution (2) contains 0.030% w/v of terfenadine BPCRS in the mobile phase. Solution (3) contains 0.015% w/v of terfenadine impurity A EPCRS in a mixture of equal volumes of solution (2) and the mobile phase.

The chromatographic procedure may be carried out using (a) a stainless steel column (30  cm × 3.9  mm) packed with end-capped octadecylsilyl silica gel for chromatography (10 µm) (µBondapak C18 is suitable), (b) as the mobile phase with a flow rate of 2  ml per minute a mixture of 6  volumes of diethylamine, 350  volumes of water, 500  volumes of acetonitrile and 100  volumes of phosphate buffer prepared by mixing 136.1  g of potassium dihydrogen orthophosphate with 3.2  ml of orthophosphoric acid and adding sufficient water to produce 1000  ml and (c) a detection wavelength of 254  nm.

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is greater than 1.4.

Calculate the content of C32H41NO2 using the declared content of C32H41NO2 in terfenadine BPCRS. Determine the weight per ml of the oral suspension, Appendix V G, and calculate the content of C32H41NO2, weight in volume.




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.

Oral Suspension 1Oral Suspension 15Oral Suspension 46

a) Free sample can be supplied.

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

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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.


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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