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High Quality USP/EP/BP GMP DMF FDA Aminophylline Tablets CAS NO 317-34-0 Producer

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Price: $ 0.08 / Tablet
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  • AZ012
  • Dideu
  • 317-34-0
  • 2C7H8N4O2.C2H8N2
  • 206-264-5
  • China
  • Aminophylline 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:

Email & Skype: support@dideu.com  Telephone:+86-29-89586682

Mobile:+86-15129568250; Whatsapp: +8615129568250

                                                                                 Aminophylline Tablets

Definition

Aminophylline Tablets contain Aminophylline or Aminophylline Hydrate.

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

Content of theophylline, C7H8N4O281.4  to 90.0% of the stated amount of Aminophylline.
Content of ethylenediamine, C2H8N2

Not less than 10.9% and not more than 12.1% of the stated amount of Aminophylline.





Identification

A.  Shake a quantity of the powdered tablets containing 0.5  g of Aminophylline with 20  ml of water, filter, add to the filtrate with constant stirring 1  ml of 2m hydrochloric acid, allow to stand for a few minutes and again filter. Reserve the filtrate for test C. Wash the residue with small quantities of cold water, recrystallise from hot water and dry at 105°. The melting point of the residue is about 271°, Appendix V A.


B.  The infrared absorption spectrum of the residue obtained in test A, Appendix II A, is concordant with the reference spectrum of theophylline (RS 333).


C.  To the filtrate reserved in test A add 0.2  ml of benzoyl chloride, make alkaline with 5m sodium hydroxide and shake vigorously. Filter, wash the residue with cold water and recrystallise from a mixture of 1  volume of water and 3  volumes of ethanol (96%). The melting point of the crystals, after drying at 100°, is about 250°, Appendix V A.


D.  Shake a quantity of the powdered tablets containing 0.25  g of Aminophylline with 5  ml of water and filter. To 2  ml of the filtrate add 2  ml of a 1% w/v solution of copper (ii) sulphate and shake. A purplish blue colour is produced.



Tests

Related substances

Dissolution of theophylline

Comply with the dissolution test for tablets and capsules, Appendix  XII  B1, using Apparatus  2.


test conditions

(a)  Use Apparatus 2, rotating the paddle at 50 revolutions per minute.

(b)  Use 900 ml of phosphate buffer pH 7.0, at a temperature of 37°, as the medium.


procedure

Withdraw a sample of 10  ml of the medium and filter. Carry out the method for liquid chromatography, Appendix  III  D, using the following solutions.


(1)  Use the filtered dissolution medium, diluted with phosphate buffer pH 7.0, if necessary to produce a solution expected to contain 0.001% w/v theophylline.

(2)  0.001% w/v solution of theophylline BPCRS in phosphate buffer pH 7.0.


chromatographic conditions

(a)  Use a stainless steel column (10  cm × 4.6  mm) packed with particles of silica the surface of which has been modified with chemically-bonded phenyl groups (5 µm) (Apex Phenyl is suitable).

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

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

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 273 nm.

(f)  Inject 20 µl of each solution.


mobile phase 

45  volumes of methanol and 55  volumes of water.


determination of content

Calculate the total content of theophylline, C7H8N4O2, in the medium using the declared content of C7H8N4O2 in theophylline BPCRS.





Assay

For theophylline

Weigh and powder 20  tablets. Shake a quantity of the powder containing 80  mg of Aminophylline with a mixture of 20  ml of 0.1m sodium hydroxide and 60  ml of water for 10  minutes, add sufficient water to produce 200  ml, mix and filter. Dilute 5  ml of the filtrate to 250  ml with 0.01m sodium hydroxide and measure the absorbance of the resulting solution at the maximum at 275  nm, Appendix II B. Calculate the content of C7H8N4O2  taking 650 as the value of A (1%, 1  cm) at the maximum at 275  nm.


For ethylenediamine

Weigh and powder 20  tablets. Shake a quantity of the powder containing 0.3  g of Aminophylline with 20  ml of water, heat to 50° for 30  minutes and titrate with 0.05m sulphuric acid VS, using bromocresol green solution as indicator, until the colour changes from blue to green. Each ml of 0.05m sulphuric acid VS is equivalent to 3.005  mg of C2H8N2.

StorageAminophylline Tablets should be kept in an airtight container and protected from light.
LabellingThe quantity of active ingredient is stated in terms of the equivalent amount of anhydrous Aminophylline.




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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