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High Quality USP/EP/BP GMP DMF FDA Etodolac Capsules CAS NO 41340-25-4 Producer

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Price: $ 0.08 / pcs
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ415
  • Dideu
  • 41340-25-4
  • C17H21NO3
  • 629-689-1
  • China
  • Etodolac 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

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Etodolac Capsules 

Action and use

Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.

Definition

Etodolac Capsules contain Etodolac.


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

Content of etodolac C17H21NO3

95.0  to 105.0% of the stated amount.
Identification

A.  To a quantity of the contents of the capsules containing about 0.1  g of Etodolac add 4  ml of 0.01m hydrochloric acid and mix with the aid of ultrasound for 5  minutes, shaking occasionally, centrifuge for 10  minutes, discard the supernatant liquid and wash the residue with 4  ml of water. Shake to disperse, centrifuge for 10  minutes and discard the supernatant liquid. Add 4  ml of 0.01m sodium hydroxide to the residue and mix with the aid of ultrasound for 5  minutes, shaking occasionally and centrifuge for 10  minutes. Transfer the supernatant liquid to a second centrifuge tube, add about 1  ml of 0.1m hydrochloric acid (the pH of the supernatant liquid should be 2 or less). Centrifuge for 10  minutes, discard the supernatant liquid and wash the residue with 4  ml of water, shake to disperse and centrifuge for 10  minutes. Discard the supernatant liquid and dry the residue at 105° for 1  hour. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of etodolac (RS 139).


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

Tests

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using as the medium 900  ml of phosphate buffer pH 7.5 and rotating the basket at 100 revolutions per minute. Withdraw a 10  ml sample of the medium and measure the absorbance of the filtered sample, suitably diluted if necessary, at the maximum at 278  nm, Appendix II B. Measure the absorbance of a suitable solution of etodolac BPCRS prepared by dissolving 30  mg in 100  ml of the dissolution medium and diluting to a suitable volume with the dissolution medium and using dissolution medium in the reference cell. Calculate the total content of etodolac, C17H21NO3 in the medium from the absorbances obtained and from the declared content of C17H21NO3 in etodolac BPCRS.


Related substances

Carry out the method for thin-layer chromatography, Appendix III A, using a silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable), previously activated by heating at 105° for 1  hour, and a mixture of 0.5  volumes of glacial acetic acid, 30  volumes of absolute ethanol and 70  volumes of toluene as the mobile phase. Place the plate in an unlined tank containing a solution prepared by dissolving 0.5  g of l-ascorbic acid in 20  ml of water and adding 80  ml of methanol. Allow the solution to ascend 1  cm above the line of application on the plate, remove the plate and allow it to dry for at least 30  minutes. Apply separately to the plate 10 µl of each of the following solutions in acetone. For solution (1) shake a quantity of the contents of the capsules containing 0.2  g of Etodolac with 20  ml of acetone, mix with the aid of ultrasound for 5  minutes and filter. For solution (2) dilute 1  volume of solution (1) to 200  volumes with acetone and for solution (3) dilute 1  volume of solution (2) to 2  volumes with acetone. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254  nm). Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%) and not more than one such spot is more intense than the spot in the chromatogram obtained with solution (3) (0.25%).


Etodolac acid dimer

Carry out the method for thin-layer chromatography, Appendix III A, using a silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable), previously activated by heating at 105° for 1  hour, and a mixture of 3  volumes of glacial acetic acid, 17  volumes of 1,4-dioxan and 60  volumes of toluene as the mobile phase. Place the plate in an unlined tank containing a solution prepared by dissolving 0.5  g of l-ascorbic acid in 20  ml of water and adding 80  ml of methanol. Allow the solution to ascend 1  cm above the line of application on the plate, remove the plate and allow it to dry for at least 30  minutes. Apply separately to the plate 20 µl of each of the following solutions. For solution (1) shake a quantity of the contents of the capsules containing 0.6  g of Etodolac with 20  ml of acetone, mix with the aid of ultrasound for 5  minutes and filter. Solution (2) contains 0.003% w/v of etodolac acid dimer BPCRS in acetone. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254  nm). Any secondary spot in the chromatogram obtained with solution (1) corresponding to the acid dimer is not more intense than the spot in the chromatogram obtained with solution (2) (0.1%).


Total methyl analogue impurities

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 0.1  g of Etodolac with 40  ml of methanol, mix with the aid of ultrasound for 5  minutes, filter and dilute 10  ml of the filtrate to 25  ml with water. For solution (2) dilute 1  volume of a solution containing 0.025% w/v each of etodolac 1-methyl analogue BPCRS and etodolac 8-methyl analogue BPCRS in methanol to 50  volumes with water.


The chromatographic procedure may be carried out using (a) a stainless steel column (20  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable), (b) a mixture of 13  volumes of acetonitrile, 19  volumes of methanol and 68  volumes of a 1.74% w/v solution of dipotassium hydrogen orthophosphate as the mobile phase with a flow rate of 1.0  ml per minute and (c) a detection wavelength of 225  nm. Adjust the mobile phase, if necessary, to give a retention time of 14  to 20  minutes for etodolac. The order of elution of peaks in the chromatogram obtained with solution (2) is etodolac 8-methyl analogue and etodolac 1-methyl analogue. 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 (2), the resolution factor between the two methyl analogue impurities is at least 0.75.


Calculate the percentage content of etodolac 1-methyl analogue and etodolac 8-methyl analogue in etodolac by reference to the corresponding peaks in the chromatogram obtained with solution (2). The total content is not greater than 1.0%.

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) shake a quantity of the mixed contents of 20 capsules containing 50  mg of Etodolac with about 70  ml of 0.1m sodium hydroxide for 30  minutes, dilute to 100  ml with 0.1m sodium hydroxide, mix and filter through a glass-fibre filter (Whatman GF/C is suitable) and dilute 2  ml of the filtrate to 100  ml with the mobile phase. For solution (2) dilute 2  ml of a 0.05% w/v solution of etodolac BPCRS in 0.1m sodium hydroxide to 100  ml with the mobile phase. For solution (3) add 2  ml of a 0.05% w/v solution of etodolac 1-methyl analogue BPCRS in 0.1m sodium hydroxide to 2  ml of a 0.05% w/v solution of etodolac BPCRS in 0.1m sodium hydroxide and dilute to 100  ml with the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (12.5  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable), (b) a mixture of 45  volumes of acetonitrile and 55  volumes of phosphate buffer pH 4.75 as the mobile phase with a flow rate of 1  ml per minute and (c) a detection wavelength of 225  nm.


The test is not valid unless the resolution factor between etodolac and etodolac 1-methyl analogue in the chromatogram obtained with solution (3) is at least 1.5.


Calculate the content of C17H21NO3 using the declared content of C17H21NO3 in etodolac 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

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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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