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High Quality USP/EP/BP GMP DMF FDA Co-tenidone Tablets CAS NO Producer

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Price: $ 0.08 / Tablet
Quantity:
min order: 1 Tablet
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ086
  • Dideu
  • China
  • Co-tenidone Tablets
  • High quality
  • 99.0% Min
  • 99%-101%
  • Tablet
  • 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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Co-tenidone Tablets

Action and use

Beta-adrenoreceptor antagonist + thiazide like diuretic.

Definition

Co-tenidone Tablets contain Atenolol and Chlortalidone in the proportions, by weight, 4 parts to 1 part.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of atenolol, C14H22N2O3

95.0  to 105.0% of the stated amount.
Content of chlortalidone, C14H11ClN2O4S92.5  to 107.5% of the stated amount.
Identification

A.  Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.

(1)  Remove any film coating from the tablets, powder and shake a quantity of the powdered tablets containing 0.1  g of atenolol with 10  ml of methanol for 15  minutes and filter.

(2)  1.0% w/v of atenolol BPCRS in methanol.

(3)  0.25% w/v of chlortalidone BPCRS in methanol.


chromatographic conditions

(a)  Use as the coating silica gel GF254.

(b)  Use the mobile phase as described below. 

(c)  Apply 5 µl of each solution.

(d)  Develop the plate to 15 cm.

(e)  After removal of the plate, allow it to dry in air and examine under ultraviolet light (254  nm).


mobile phase

30  volumes of 18m ammonia and 150  volumes of butan-1-ol.


confirmation

In the chromatogram obtained with solution (1) the two principal spots correspond in position, size and intensity to those of the principal spots in the chromatograms obtained with solutions (2) and (3).


B.  In the Assay, the retention times of the two principal peaks in the chromatogram obtained with solution (1) correspond to those of the principal peaks in the chromatograms obtained with solutions (2) and (3).

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.


(1)  Remove any film coating from the tablets, powder and shake a quantity of the powder containing 0.1  g of atenolol (and 0.025  g of chlortalidone) with 25  ml of the mobile phase for 30  minutes with the aid of ultrasound. Filter through a suitable filter (Whatman No l is suitable) and use the filtrate.

(2)  Dilute 1  volume of solution (1) to 200  volumes with the mobile phase.

(3)  Dissolve 50  mg of atenolol impurity standard BPCRS in 0.1  ml of dimethyl sulphoxide, with the aid of gentle heat, and dilute to 100  ml with the mobile phase.

(4)  0.002% w/v of 2-(4-chloro-3-sulphamoylbenzoyl)benzoic acid BPCRS in the mobile phase.


chromatographic conditions 

(a)  Use a stainless steel column (15  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 2 is suitable).

(b)  Use isocratic elution and the mobile phase described below.

(c)  Use a flow rate of 2 ml per minute.

(d)  Use ambient column temperature.

(e)  Use a detection wavelength of 226 nm.

(f)  Inject 20 µl of each solution.


mobile phase 

20  volumes of tetrahydrofuran, 180  volumes of methanol and 800  volumes of 0.025m potassium dihydrogen orthophosphate containing 1.0  g of sodium octanesulphonate and 0.4  g of tetrabutylammonium hydrogen sulphate per litre and adjusted to pH 3.0 with orthophosphoric acid.


system suitability

The test is not valid unless the chromatogram obtained with solution (3) closely resembles the reference chromatogram supplied with atenolol impurity standard BPCRS and the peaks corresponding to tertiary amine, which is usually a doublet, and bis ether are clearly separated. If necessary, adjust the concentration of sodium octanesulphonate in the mobile phase; increasing the concentration increases the retention time of the tertiary amine.


limits

In the chromatogram obtained with solution (1):


the area of any peak corresponding to 2-(4-chloro-3-sulphamoyl-benzoyl)benzoic acid is not greater than the area of the peak in the chromatogram obtained with solution (4) (2%, with reference to the content of chlortalidone);


the area of any peak corresponding to blocker acid is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%, with reference to the content of atenolol);


the area of any peak corresponding to either tertiary amine or bis ether is not greater than half of the area of the principal peak in the chromatogram obtained with solution (2) (0.25%, with reference to the content of atenolol).

Assay

Weigh 20 tablets, remove the film coating and powder. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.


(1)  Extract a quantity of the powder containing 0.1  g of atenolol with 70  ml of the mobile phase by shaking with the aid of ultrasound for 30  minutes, allow to cool, add sufficient of the mobile phase to produce 100 ml, filter and use the filtrate.

(2)  0.1% w/v of atenolol BPCRS in the mobile phase.

(3)  0.025% w/v of chlortalidone BPCRS in the mobile phase.


chromatographic conditions 

(a)  Use a stainless steel column (20  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 is suitable).

(b)  Use isocratic elution and the mobile phase described below.

(c)  Use a flow rate of 1.0 ml per minute.

(d)  Use ambient column temperature. 

(e)  Use a detection wavelength of 275 nm.

(f)  Inject 20 µl of each solution.


mobile phase 

10  volumes of sulphuric acid (10%), 50  volumes of propan-2-ol, 200  volumes of acetonitrile and 740  volumes of water containing 0.5  g per litre of sodium octanesulphonate and adjusted to pH 3.0 with 2m sodium hydroxide.


determination of content 

Calculate the content of C14H22N2O3 and of C14H11ClN2O4S using the declared contents of C14H22N2O3 and of C14H11ClN2O4S in atenolol BPCRS and in chlortalidone BPCRS, respectively.


When atenolol and chlorthalidone tablets are prescribed or demanded, Co-tenidone Tablets shall be dispensed or supplied.




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.

2316

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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