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High Quality USP/EP/BP GMP DMF FDA Gemfibrozil Capsules CAS NO 25812-30-0 Producer

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Price: $ 0.08 / pcs
Quantity:
min order: 1 pcs
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ426
  • Dideu
  • 25812-30-0
  • C15H22O3
  • 247-280-2
  • China
  • Gemfibrozil Capsules
  • High quality
  • 99.0% Min
  • 99%-101%
  • Capsule
  • 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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Gemfibrozil Capsules 

Action and use

Fibrate lipid-regulating drug.

Definition

Gemfibrozil Capsules contain Gemfibrozil.


The capsules comply with the requirements stated under Capsules and with the following requirements.

Content of gemfibrozil, C15H22O3

95.0  to 105.0% of the stated amount.
Identification

Shake a quantity of the contents of the capsules containing about 0.5  g of Gemfibrozil with 10  ml of n-hexane for 10  minutes, filter through a filter paper previously washed with 20  ml of n-hexane, evaporate the filtrate to dryness on a water bath and then dry over silica gel at a pressure of 2  kPa for 2  hours or until a waxy solid is obtained. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of gemfibrozil (RS 167).

Tests

Related substances

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 0.2m phosphate buffer pH 7.5 and rotate the paddle at 50 revolutions per minute. Withdraw a 10  ml sample of the medium and measure the absorbance of the filtered sample, suitably diluted with the dissolution medium if necessary, at the maximum at 276  nm, Appendix II B. At the same time measure the absorbance at the maximum at 276  nm of a suitable solution of gemfibrozil BPCRS in the dissolution medium, adding the minimum volume of 0.1m sodium hydroxide, if necessary, to complete dissolution. Calculate the total content of gemfibrozil, C15H22O3, in the medium from the absorbances obtained and from the declared content of C15H22O3 in gemfibrozil BPCRS.


Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) shake a quantity of the contents of the capsules containing 0.4  g of Gemfibrozil with 100  ml of methanol and filter. For solution (2) dilute 1  volume of solution (1) to 100  volumes with the mobile phase and further dilute 1  volume of this solution to 5  volumes with the mobile phase. Solution (3) contains 0.0004% w/v of gemfibrozil impurity A BPCRS in the mobile phase. Solution (4) contains 0.001% w/v of gemfibrozil methyl ester BPCRS and 0.0004% w/v of gemfibrozil impurity A BPCRS in solution (2).


The chromatographic procedure described under Assay may be used. For solution (1) allow the chromatography to proceed for twice the retention time of the principal peak.


The test is not valid unless, in the chromatogram obtained with solution (4), the resolution factor between the peaks due to gemfibrozil and gemfibrozil methyl ester is at least 4.0 and the resolution factor between the peaks due to gemfibrozil methyl ester and gemfibrozil impurity A is at least 1.2.


In the chromatogram obtained with solution (1) the area of any peak corresponding to gemfibrozil impurity A is not greater than the area of the peak in the chromatogram obtained with solution (3) (0.1%), the area of any other secondary peak is not greater than the area of the peak in the chromatogram obtained with solution (2) (0.2%) and the sum of the areas of any secondary peaks other than any peak corresponding to gemfibrozil impurity A is not greater than 2.5  times the area of the peak in the chromatogram obtained with solution (2) (0.5%).

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) add 50  ml of methanol to a quantity of the mixed contents of 20 capsules containing 0.15  g of Gemfibrozil, shake on a mechanical shaker for 10  minutes, add 20  ml of water, 1  ml of glacial acetic acid and sufficient methanol to produce 100  ml, mix and filter (Whatman GF/C paper is suitable), discarding the first 20  ml of filtrate. Dilute 1  volume of the filtrate to 5  volumes with the mobile phase. For solution (2) dissolve 30  mg of gemfibrozil BPCRS in 80  ml of methanol, add 1  ml of glacial acetic acid and dilute to 100  ml with water. Solution (3) contains 0.01% w/v of gemfibrozil methyl ester BPCRS in a solution prepared by diluting 1  volume of solution (1) to 3  volumes with the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (10  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (3 µm) (Spherisorb ODS 2 or Regis C18 are suitable), (b) a mixture of 1  volume of glacial acetic acid, 19  volumes of water and 80  volumes of methanol as the mobile phase with a flow rate of 1  ml per minute and (c) a detection wavelength of 276  nm.


Inject 20 µl of each solution. The test is not valid unless in the chromatogram obtained with solution (3) the resolution factor between the peaks due to gemfibrozil and gemfibrozil methyl ester is at least 4.0.


Calculate the content of C15H22O3 in the capsules from the declared content of C15H22O3 in gemfibrozil BPCRS.




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.

Capsules 1CapsulesCapsules 106

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

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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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