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High Quality USP/EP/BP GMP DMF FDA Busulfan Tablets CAS NO 55-98-1 Producer

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Price: $ 0.08 / Tablet
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  • AZ035
  • Dideu
  • 55-98-1
  • C6H14O6S2
  • 200-250-2
  • China
  • Busulfan 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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                                                                                 Busulfan Tablets 

Action and use

Cytotoxic alkylating agent.

Definition

Busulfan Tablets contain Busulfan. They are coated.

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

Content of busulfan, C6H14O6S2

90.0  to 115.0% of the stated amount.



Identification

A.  Shake a quantity of the powdered tablets containing 10  mg of Busulfan with 10  ml of hot acetone, filter and evaporate the filtrate to dryness. Dry the residue at 60° at a pressure not exceeding 0.7  kPa for 1  hour. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of busulfan (RS 035).

B.  In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (3) is similar to that of the principal peak in the chromatogram obtained with solution (1).



Tests


Disintegration

Maximum time, 15  minutes, Appendix XII A1.


Uniformity of content

Tablets containing less than 2  mg of Busulfan comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for gas chromatography, Appendix III B, using the following solutions. Prepare a 0.0001% w/v solution of 1,5-di-iodopentane (internal standard) in acetone (solution A). 

(1)  Add 5  ml of a 30% w/v solution of sodium iodide in acetone to 5  ml of a 0.0001% w/v solution of busulfan BPCRS in acetone, stopper the flask lightly and heat in a water bath at 50° for 90  minutes. Cool, add 10  ml of solution A, mix, add 10  ml of water and 20  ml of hexane, shake vigorously for 1  minute and allow to separate. Use the hexane layer.

(2)  Prepare solution (2) in the same manner as solution (3) but using 10  ml of acetone in place of solution A.

(3)  Add 1  ml of water to one tablet in a 50  ml graduated flask and mix with the aid of ultrasound until completely dispersed. Add 30  ml of acetone, shake for 15  minutes and dilute to 50  ml with acetone. Centrifuge and dilute a quantity of the supernatant liquid with acetone to produce a solution containing 0.0001% w/v of Busulfan. To 5  ml of the resulting solution add 5  ml of a 30% w/v solution of sodium iodide in acetone, stopper the flask lightly and heat in a water bath at 50° for 90  minutes. Cool, add 10  ml of solution A, mix, add 10  ml of water and 20  ml of hexane, shake vigorously for 1  minute and allow to separate. Use the hexane layer.


chromatographic conditions

(a)  Use a glass column (1.5 m × 4  mm) packed with acid-washed, diatomaceous support (80  to 100  mesh) coated with 3% w/w of phenyl methyl silicone fluid (50% phenyl) (OV-17 is suitable). 

(b)  Use helium as the carrier gas at 1.7 ml per minute.

(c)  Use isothermal conditions maintained at 140°.

(d)  Use an inlet temperature of 160°.

(e)  Use an electron capture detector.

(f)  Inject 1 µl of each solution.


determination of content

Calculate the content of C6H14O6S2 using the declared content of C6H14O6S2 in busulfan BPCRS.




Assay

Weigh and powder 20  tablets. Carry out the method for gas chromatography, Appendix III B, using the following solutions. Prepare a 0.0001% w/v solution of 1,5-di-iodopentane (internal standard) in acetone (solution A). 

(1)  Add 5  ml of a 30% w/v solution of sodium iodide in acetone to 5  ml of a 0.0001% w/v solution of busulfan BPCRS in acetone, stopper the flask lightly and heat in a water bath at 50° for 90  minutes. Cool, add 10  ml of solution A, mix, add 10  ml of water and 20  ml of hexane, shake vigorously for 1  minute and allow to separate. Use the hexane layer.

(2)  Prepare solution (2) in the same manner as solution (3) but using 10  ml of acetone in place of solution A.

(3)  Add 5  ml of water to a quantity of powdered tablets containing 2.5  mg of Busulfan and mix with the aid of ultrasound until completely dispersed. Add 150  ml of acetone, shake for 15  minutes and dilute to 250  ml with acetone. Centrifuge and dilute 10  ml of the supernatant liquid to 100  ml with acetone. To 5  ml of the resulting solution add 5  ml of a 30% w/v solution of sodium iodide in acetone, stopper the flask lightly and heat in a water bath at 50° for 90  minutes. Cool, add 10  ml of solution A, mix, add 10  ml of water and 20  ml of hexane, shake vigorously for 1  minute and allow to separate. Use the hexane layer.


chromatographic conditions

The chromatographic conditions described under Uniformity of content may be used.


determination of content

Calculate the content of C6H14O6S2 using the declared content of C6H14O6S2 in busulfan 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.

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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