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High Quality USP/EP/BP GMP DMF FDA Spironolactone Tablets CAS NO 52-01-7 Producer

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Price: $ 0.08 / Tablet
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  • AZ343
  • Dideu
  • 52-01-7
  • C24H32O4S
  • 200-133-6
  • China
  • Spironolactone 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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Spironolactone Tablets 

Action and use

Aldosterone receptor antagonist; potassium-sparing diuretic.

Definition

Spironolactone Tablets contain Spironolactone.

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

Content of spironolactone, C24H32O4S

95.0  to 105.0% of the stated amount.
Identification

A.  Extract a quantity of the powdered tablets containing 0.125  g of Spironolactone with two 10  ml quantities of chloroform, filter, evaporate the combined filtrates to dryness and dissolve the residue in 2.5  ml of chloroform. The infrared absorption spectrum of the resulting solution, Appendix II A, is concordant with the reference spectrum of spironolactone (RS 321).


B.  Carry out the method for thin-layer chromatography, Appendix III A, using silica gel GF254 as the coating substance and a mixture of 1  volume of water, 24  volumes of cyclohexane and 75  volumes of ethyl acetate as the mobile phase. Apply separately to the plate 5 µl of each of the following solutions. For solution (1) extract a quantity of the powdered tablets containing 20  mg of Spironolactone with 10  ml of dichloromethane. Solution (2) contains 0.2% w/v of spironolactone EPCRS in dichloromethane. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254  nm). The principal spot in the chromatogram obtained with solution (1) is similar in position and size to that 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 Apparatus 2. Use as the medium 1000  ml of 0.1m hydrochloric acid containing 0.1% w/v sodium dodecyl sulphate and rotate the paddle at 75 revolutions per minute. Withdraw a sample of 10  ml of the medium, filter and measure the absorbance of the filtrate, suitably diluted if necessary, at the maximum at 242  nm, Appendix II B. Calculate the total content of C24H32O4S in the medium taking 445 as the value of A(1%, 1  cm) at the maximum at 242  nm.


Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) disperse a quantity of the powdered tablets containing 62.5  mg of Spironolactone with 25  ml of chloroform, place in an ultrasonic bath for 5  minutes, shake for 10  to 15  minutes, centrifuge and filter the supernatant liquid through glass fibre paper (Whatman GF/C is suitable). Repeat the procedure on the residue with a further 25  ml of chloroform. Combine the chloroform extracts and evaporate to dryness using a rotary evaporator. Add 2.5  ml of tetrahydrofuran and 22.5  ml of the mobile phase to the residue. For solution (2) dilute 1  ml of solution (1) to 100  ml with the mobile phase. For solution (3) dissolve 25  mg of canrenone EPCRS in 1  ml of tetrahydrofuran and dilute to 10  ml with the mobile phase. For solution (4) dilute 1  ml of solution (3) to 100  ml with the mobile phase. For solution (5) mix 1  ml each of solutions (1) and (3) and dilute to 100  ml with the mobile phase. For solution (6) dilute 0.5  ml of solution (2) to 10  ml with the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (15  cm × 4.6  mm) packed with end-capped octylsilyl silica gel for chromatography (5 µm) (Spherisorb C8 is suitable), (b) a mixture of 8  volumes of acetonitrile, 18  volumes of tetrahydrofuran and 74  volumes of water as the mobile phase with a flow rate of 1.8  ml per minute and (c) detection wavelengths of 254  nm and 283  nm as directed below.


Inject separately 20 µl of each of solutions (1), (2), (5) and (6) and record the chromatograms for twice the retention time of spironolactone using a detection wavelength of 254  nm. In the chromatogram obtained with solution (1) the sum of the areas of any secondary peaks, other than any peak corresponding to canrenone, is not greater than the area of the peak due to spironolactone in the chromatogram obtained with solution (2) (1%). Disregard any peak the area of which is less than that of the principal peak in the chromatogram obtained with solution (6).


Inject 20 µl of each of solutions (1) and (4) and record the chromatograms using a detection wavelength of 283  nm. The test is not valid unless (a) the chromatogram obtained with solution (5) shows two peaks due to canrenone and spironolactone with a resolution factor greater than 1.4 and (b) the principal peak in the chromatogram obtained with solution (6) has a signal-to-noise ratio of at least 6.


In the chromatogram obtained with solution (1) the area of any peak corresponding to canrenone is not greater than that of the peak due to canrenone in the chromatogram obtained with solution (4) (1%). Calculate the percentage content of canrenone found when recording at 283  nm and the percentage content of the other related substances found when recording at 254  nm. The sum is not greater than 1.0%.

Assay

Weigh and powder 20  tablets. To a quantity of the powder containing 25  mg of Spironolactone add 100  ml of methanol and heat just to boiling, with swirling. Cool, add sufficient methanol to produce 250  ml, dilute 10  ml to 100  ml with methanol and measure the absorbance of the resulting solution at the maximum at 238  nm, Appendix II B. Calculate the content of C24H32O4S taking 470 as the value of A(1%, 1  cm) at the maximum at 238  nm.

Storage

Spironolactone Tablets should be protected from light.




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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