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High Quality USP/EP/BP GMP DMF FDA Fenbendazole Oral Suspension CAS NO 43210-67-9 Producer

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  • AZ578
  • Dideu
  • 43210-67-9
  • C15H13N3O2S
  • 256-145-7
  • 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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Fenbendazole Oral Suspension 

Action and use

Antihelminthic.

Definition

Fenbendazole Oral Suspension is an aqueous suspension of Fenbendazole.

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

Content of fenbendazole, C15H13N3O2S

95.0 to 105.0% of the stated amount.

Identification

In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is the same as that of the principal peak in the chromatogram obtained with solution (2).

Tests

Related substances

Tests

Related impurities A, B and 1

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1), mix with the aid of ultrasound, a quantity of the oral suspension containing 0.1 g of Fenbendazole with 50 ml of 0.1m methanolic hydrochloric acid for 30 minutes, cool, dilute to 100 ml with methanol (65%), mix, filter through a glass-fibre filter (Whatman GF/C is suitable). For solution (2), dilute 1 volume of a 0.001% w/v solution of fenbendazole impurity A EPCRS (methyl (1H-benzimidazol-2-yl)carbamate) in 0.1m methanolic hydrochloric acid to 2 volumes with methanol (65%). For solution (3) dilute 1 volume of a 0.001% w/v solution of fenbendazole impurity B EPCRS (methyl(5-chloro-1H-benzimidazol-2-yl)carbamate in 0.1m methanolic hydrochloric acid to 2 volumes with methanol (65%). For solution (4) dilute 1 volume of a 0.001% w/v solution of fenbendazole impurity 1 BPCRS (5-phenylthio)-2-aminobenzimidazole) in 0.1m methanolic hydrochloric acid to 2 volumes with methanol (65%). For solution (5) dilute 1 volume of a solution containing 0.002% w/v each of fenbendazole impurity A EPCRS, fenbendazole impurity B EPCRS, fenbendazole impurity 1 BPCRS and 0.20% w/v of fenbendazole BPCRS in 0.1m methanolic hydrochloric acid to 2 volumes with methanol (65%).

The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 is suitable), (b) as the mobile phase with a flow rate of 1 ml per minute a mixture of 350 volumes of a 0.5% w/v solution of sodium dihydrogen orthophosphate and 650 volumes of methanol containing 1.88 g of sodium hexanesulphonate, the pH of which has been adjusted to 3.5 with orthophosphoric acid and (c) a detection wavelength of 280 nm. 

Inject separately 20 µl of each solution. The test is not valid unless the chromatogram obtained with solution (5) closely resembles the reference chromatogram supplied with fenbendazole BPCRS. 

In the chromatogram obtained with solution (1) the areas of any peaks corresponding to fenbendazole impurity A (methyl (1H-benzimidazol-2-yl)carbamate), fenbendazole impurity B (methyl (5-chloro-1H-benzimidazol-2-yl)carbamate) and fenbendazole impurity 1 (5-(phenylthio)-2-aminobenzimidazole) are not greater than the areas of the corresponding peaks in the chromatograms obtained with solutions (2), (3) and (4) respectively (0.5% each). 

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) mix with the aid of ultrasound a quantity of the oral suspension containing 0.1 g of Fenbendazole with 50 ml of 0.1m methanolic hydrochloric acid for 30 minutes, cool, dilute to 100 ml with methanol (65%), mix, filter through a glass-fibre filter (Whatman GF/C is suitable). Dilute 5 volumes of the resulting solution to 50 volumes with 0.1m hydrochloric acid in methanol (85%). Solution (2) contains 0.01% w/v of fenbendazole BPCRS in a mixture of 1 volume of 0.1m hydrochloric acid and 1 volume of methanol (85%).

The chromatographic procedure described under Related substances may be used.

Calculate the total content of C15H13N3O2S in the oral suspension from the chromatogram obtained and using the declared content of C15H13N3O2S in fenbendazole BPCRS.

Impurities

The impurities limited by the requirements of this monograph include impurities A and B listed under Fenbendazole and the following:

B)SVPGF06OMZ`_40RRH




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.

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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