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High quality USP/EP/BP GMP DMF FDA Allopurinol Tablets CAS NO 315-30-0 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
  • AZ007
  • Dideu
  • 315-30-0
  • C5H4N4O
  • 206-250-9
  • China
  • Allopurinol 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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                                                                               Allopurinol Tablets

Action and use Xanthine oxidase inhibitor; treatment of gout and hyperuricaemia.

Definition

Allopurinol Tablets contain Allopurinol.

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

Content of allopurinol, C5H4N4O

92.5  to 107.5% of the stated amount.

Identification

A.  The light absorption, Appendix II B, in the range 230  to 350  nm of the solution obtained in the Assay exhibits a maximum only at 250  nm.

B.  Shake a quantity of the powdered tablets containing 0.1  g of Allopurinol with 5  ml of 1.25m sodium hydroxide and add 3  ml of phosphomolybdotungstic reagent and 5  ml of a 20% w/v solution of sodium carbonate. A greyish blue colour is produced.
















Tests

Related substances

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

(1)  Mix with the aid of ultrasound a quantity of the powdered tablets containing 0.1  g of Allopurinol with 10  ml of 0.1m sodium hydroxide for about 1  minute, immediately dilute to 200  ml with mobile phase A and filter (Whatman GF/C is suitable). 

(2)  Dilute 1  volume of solution (1) to 100  volumes with mobile phase A and further dilute 1  volume to 10  volumes with mobile phase A. 

(3)  Dissolve 10  mg of allopurinol impurity A BPCRS and 5  mg each of allopurinol impurity B BPCRS, allopurinol impurity C EPCRS, allopurinol impurity D EPCRS and allopurinol impurity E EPCRS in mobile phase A. Add 20  ml of solution (1) and immediately dilute to 100  ml with mobile phase A. Dilute 1  ml of the resulting solution to 100  ml with mobile phase A.


chromatographic conditions

(a)  Use a stainless steel column (25  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 5µ is suitable).

(b)  Use gradient 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 230 nm.

(f)  Inject 20 µl of each solution.


mobile phase

Mobile phase A  A mixture of 1  volume of methanol and 9  volumes of a 0.125% w/v solution of potassium dihydrogen orthophosphate.

Mobile phase B  A mixture of 3  volumes of methanol with 7  volumes of a 0.125% w/v solution of potassium dihydrogen orthophosphate.


Allopurinol Tablets

system suitability

The test is not valid unless in solution (3) the resolution factor between the peaks corresponding to impurity A and allopurinol is at least 3.

Inject solution (3). When the chromatogram is recorded in the prescribed conditions, the retention times are: impurity A, about 4.2  minutes; impurities B and C, about 6.1  minutes; allopurinol, about 7.7  minutes; impurity D, about 26.1  minutes; impurity E, about 27.8  minutes. Inject solution (1) and solution (2). Continue the chromatography of solution (1) for 5  times the retention time of allopurinol. 


limits

In the chromatogram obtained with solution (1):

the area of any peak corresponding to impurity A is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (0.2%);

the area of any unresolved double peak corresponding to impurities B and C is not greater than the area of the corresponding double peak in the chromatogram obtained with solution (3) (0.2%);


the area of any peaks corresponding to impurity D or impurity E is not greater than the area of the corresponding 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 due to allopurinol in the chromatogram obtained with solution (2) (0.1%);


the sum of the areas of any other secondary peaks is not greater than 3  times the area of the peak due to allopurinol in the chromatogram obtained with solution (2) (0.3%).


Disregard any peak with an area less than 0.2  times that of the peak due to allopurinol in the chromatogram obtained with solution (2) (0.02%).




Assay

Weigh and powder 20  tablets. Shake a quantity of the powder containing 0.1  g of Allopurinol with 20  ml of 0.05m sodium hydroxide for 20  minutes, add 80  ml of 0.1m hydrochloric acid, shake for 10  minutes, add sufficient 0.1m hydrochloric acid to produce 250  ml, filter and dilute 10  ml of the filtrate to 250  ml with 0.1m hydrochloric acid. Measure the absorbance of the resulting solution at the maximum at 250  nm, Appendix II B, using 0.1m hydrochloric acid in the reference cell. Calculate the content of C5H4N4O taking 563 as the value of A (1%, 1  cm) at the maximum at 250  nm.





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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