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High Quality USP/EP/BP GMP DMF FDA Amiloride Tablets CAS NO 2609-46-3 Producer

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  • AZ010
  • Dideu
  • 2609-46-3
  • C6H8ClN7O
  • 220-024-7
  • China
  • Amiloride 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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                                                                              Amiloride Tablets

Action and useSodium channel blocker; potassium-sparing diuretic.

Definition

Amiloride Tablets contain Amiloride Hydrochloride.


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

Content of anhydrous amiloride hydrochloride, C6H8ClN7O,HCl

90.0  to 110.0% of the stated amount.

Identification

A.  Extract a quantity of the powdered tablets containing the equivalent of 0.5  mg of anhydrous amiloride hydrochloride with 100  ml of 0.1m hydrochloric acid and filter. The light absorption of the filtrate, Appendix II B, in the range 230  to 380  nm exhibits two maxima, at 285  nm and at 361  nm.


B.  In the test for Related substances, the principal peak in the chromatogram obtained with solution (1) has the same retention time as the principal peak in the chromatogram obtained with solution (5).








Tests

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a mixture of 1  volume of acetonitrile and 3  volumes of water.

(1)  Shake a quantity of the powdered tablets containing the equivalent of 17.5  mg of anhydrous amiloride hydrochloride with 10  ml of a mixture of 1  volume of acetonitrile and 3  volumes of water, disperse with the aid of ultrasound for 5  minutes and centrifuge.

(2)  Dilute 1  volume of solution (1) to 100  volumes.

(3)  Dilute 1  volume of solution (2) to 10  volumes.

(4)  0.0010% w/v of methyl 3,5-diamino-6-chloropyrazine-2-carboxylate EPCRS.

(5)  0.175% w/v of amiloride hydrochloride BPCRS.


chromatographic conditions 

(a)  Use a stainless steel column (25  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  ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 254  nm.

(f)  Inject 20 µl of each solution.

(g)  Allow the chromatography to proceed for 5 times the retention time of the peak due to amiloride.


mobile phase 

5  volumes of tetramethylammonium hydroxide solution, 250  volumes of acetonitrile and 745  volumes of water, the pH of the mixture being adjusted to 7.0 using a mixture of 1  volume of orthophosphoric acid and 9  volumes of water.

Adjust the concentration of acetonitrile so that, in the chromatogram obtained with solution (4), the retention time of methyl 3,5-diamino-6-chloropyrazine-2-carboxylate is 5  to 6  minutes (an increase in the concentration of acetonitrile reduces the retention time). Adjust the concentrations of tetramethylammonium hydroxide and orthophosphoric acid so that, in the chromatogram obtained with solution (2), the retention time of amiloride is 9  to 12  minutes keeping the pH at 7.0 (an increase in the concentrations reduces the retention time).


system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the signal-to-noise ratio of the peak due to amiloride in the chromatogram obtained is at least 5.0.


limits 

In the chromatogram obtained with solution (1):


the sum of the areas of any secondary peaks is not greater than the area of the peak due to methyl 3,5-diamino-6-chloropyrazine-2-carboxylate in the chromatogram obtained with solution (4) (0.6%).


Disregard any peak with an area less than 0.1 times the area of the peak due to methyl 3,5-diamino-6-chloropyrazine-2-carboxylate in the chromatogram obtained with solution (4) (0.06%).


Assay

Weigh and powder 20  tablets. To a quantity of the powder containing the equivalent of 10  mg of anhydrous amiloride hydrochloride add 10  ml of methanol and shake for 10  minutes. Add 60  ml of 0.1m sodium hydroxide, shake for 30  minutes and dilute to 100  ml with 0.1m sodium hydroxide. Immediately transfer 4  ml of the resulting solution to a stoppered centrifuge tube and add 10  ml of 0.1m sodium hydroxide and 20  ml of tributyl orthophosphate that has been washed with water before use. Shake vigorously for 2  minutes and centrifuge for 5  minutes. Remove the upper layer and repeat the extraction with a further 20  ml of the water-washed tributyl orthophosphate. To the combined extracts add 2  ml of methanol and sufficient of the water-washed tributyl orthophosphate to produce 50  ml and centrifuge to remove traces of water. Measure the absorbance of the resulting solution at the maximum at 363  nm, Appendix II B, using in the reference cell a mixture of 48  volumes of the water-washed tributyl orthophosphate and 2  volumes of methanol. Calculate the content of C6H8ClN7O,HCl taking 692 as the value of A(1%, 1  cm) at the maximum at 363  nm.

LabellingThe quantity of active ingredient is stated in terms of the equivalent amount of anhydrous amiloride hydrochloride.




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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