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Prolonged-release Bezafibrate Tablets
|Action and use|| |
Fibrate; lipid-regulating drug.
Prolonged-release Bezafibrate Tablets contain Bezafibrate. They are formulated so that the medicament is released over a period of several hours.
A suitable dissolution test is carried out to demonstrate the appropriate release of bezafibrate. The dissolution profile reflects the in vivo performance which in turn is compatible with the dosage schedule recommended by the manufacturer.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of bezafibrate, C19H20ClNO4
|95.0 to 105.0% of the stated amount.|
|Identification || |
Shake a quantity of the powdered tablets containing 0.2 g of Bezafibrate with two 10-ml quantities of acetone for 10 minutes, filter the combined extracts (Whatman GF/C is suitable) and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of Bezafibrate (RS 419).
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Mix with the aid of ultrasound a quantity of the powdered tablets containing 100 mg of Bezafibrate with 15 ml of methanol for 2 minutes, shake for a further 10 minutes, cool, add sufficient mobile phase to produce 100 ml, mix and filter, discarding the first 20 ml of filtrate.
(2) Dilute 1 volume of solution (1) to 200 volumes with the mobile phase.
(3) Dissolve sufficient quantities of bezafibrate BPCRS and chlorobenzoyltyramine BPCRS in the minimum quantity of methanol and dilute with mobile phase to produce a solution containing 0.0002% w/v of bezafibrate BPCRS and 0.0002% w/v of chlorobenzoyltyramine BPCRS.
(4) Dilute 1 volume of solution (2) to 10 volumes with the mobile phase.
(a) Use a stainless steel column (15 cm × 3.9 mm) packed with octadecylsilyl silica gel for chromatography (4 µm) (Novapak C18 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1 ml per minute.
(d) Use ambient column temperature.
(e) Use a detection wavelength of 230 nm.
(f) Inject 20 µl of each solution.
The retention time of bezafibrate is about 5 minutes. Allow the chromatography to proceed for four times the retention time of the principal peak.
A mixture of 3.9 volumes of a 40% w/v solution of tetrabutylammonium hydroxide, 400 volumes of acetonitrile and 600 volumes of water, adjusting the final pH to 4.0 with 10% v/v orthophosphoric acid.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to bezafibrate and chlorobenzoyltyramine is at least 7.0. If necessary adjust the content of tetrabutylammonium hydroxide to obtain the required resolution.
In the chromatogram obtained with solution (1):
the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);
the total area of any such peaks is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.75%).
Disregard any peak with an area less than that of the principal peak in the chromatogram obtained with solution (4) (0.01%).
|Assay || |
Weigh and powder 20 tablets. For solution (1) mix with the aid of ultrasound a quantity of the powdered tablets containing 0.1 g of Bezafibrate with 70 ml of methanol for 2 minutes, shake for a further 10 minutes, cool, add sufficient methanol to produce 100 ml, mix and filter discarding the first 20 ml of filtrate. Dilute 1 volume to 100 volumes with methanol. Solution (2) is a 0.001% w/v solution of bezafibrate BPCRS in methanol.
Measure the absorbance of the resulting solutions at the maximum at about 230 nm, Appendix II B. Calculate the content of C19H20ClNO4 from the declared content of C19H20ClNO4 in bezafibrate BPCRS.
The impurities limited by the requirements of this monograph include:
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.
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:
II)Nutrition Additive Industries
III)Daily-Use Chemical Products Industries & Agrochemicals
IV)Environmental Friendly Chemical And Chemurgy 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.