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High quality USP/EP/BP GMP DMF FDA Aminoglutethimide Tablets CAS NO 125-84-8 producer

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Price: $ 0.08 / Tablet
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ011
  • Dideu
  • 125-84-8
  • C13H16N2O2
  • 204-756-4
  • China
  • Aminoglutethimide 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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                                                                              Aminoglutethimide Tablets

Action and useInhibitor of adrenal corticosteroid synthesis; used in chemical adrenalectomy.

Definition

Aminoglutethimide Tablets contain Aminoglutethimide.


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

Content of aminoglutethimide, C13H16N2O2

95.0  to 105.0% of the stated amount.

Identification

Shake a quantity of the powdered tablets containing 0.25  g of Aminoglutethimide with 10  ml of methanol for 10  minutes, filter through a 0.45-µm glass microfibre filter (Whatman GF/C is suitable) and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of aminoglutethimide (RS 403).
















Tests

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.


test conditions

(a)  Use Apparatus 1, rotating the basket at 100 revolutions per minute.

(b)  Use 900 ml of 0.1m hydrochloric acid, at a temperature of 37°, as the medium.


procedure 

(1)  After 45 minutes withdraw a sample of the medium and filter through a membrane filter with a nominal pore size not greater than 0.45 µm, discarding the first 15  ml of filtrate. Dilute the filtered solution with sufficient of a buffer solution prepared by dissolving 6.804  g of potassium dihydrogen orthophosphate in sufficient 0.04m sodium hydroxide to produce 1000  ml and adjusting the pH to 7.5 with 0.2m sodium hydroxide to produce a solution expected to contain about 0.001% w/v of Aminoglutethimide. Measure the absorbance of this solution, Appendix II B, at the maximum at 237  nm using in the reference cell dissolution medium that has been diluted in the same manner as the test solution. 

(2)  Measure the absorbance of a solution prepared by diluting a 0.025% w/v solution of aminoglutethimide BPCRS in dissolution medium to contain 0.001% w/v with the buffer solution.


determination of content 

Calculate the total content of aminoglutethimide, C13H16N2O2, in the medium from the absorbances obtained and using the declared content of C13H16N2O2 in aminoglutethimide BPCRS.


3-Aminoglutethimide

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

(1)  Add 75  ml of methanol to a quantity of the powdered tablets containing 0.5  g of Aminoglutethimide, shake for 30  minutes, dilute to 100  ml with methanol, centrifuge and dilute 10  ml of the clear supernatant liquid to 100  ml with water.

(2)  Dilute 1  volume of a 0.005% w/v solution of aminoglutethimide impurity A EPCRS in methanol to 5  volumes with water.

(3)  Dilute 1  volume of solution (1) to 10  volumes with methanol, mix 1  volume of this solution with 1  volume of a 0.005% w/v solution of aminoglutethimide impurity A EPCRS in methanol and dilute to 5  volumes with water.


chromatographic conditions 

(a)  Use a stainless steel column (25  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (10 µm) (Nucleosil C18 is suitable).

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

(c)  Use a flow rate of 1.5  ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 254 nm.

(f)  Inject 20 µl of each solution.


mobile phase 

0.5  volume of triethylamine, 160  volumes of acetonitrile and 800  volumes of water.


system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 1.0.


limits 

In the chromatogram obtained with solution (1):


the area of any peak corresponding to aminoglutethimide impurity A is not greater than the area of the peak in the chromatogram obtained with solution (2) (2%).


Related substances

Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.

(1)  Add 5  ml of methanol to a quantity of the powdered tablets containing 0.1  g of Aminoglutethimide, shake vigorously for 10  minutes, centrifuge and use the clear supernatant liquid.

(2)  2% w/v of aminoglutethimide BPCRS in methanol.

(3)  Dilute 1  volume of solution (1) to 200  volumes with methanol.


chromatographic conditions

(a)  Use a TLC silica gel F254 plate (Merck silica gel 60 F254 plates are suitable).

(b)  Use the mobile phase as described below. 

(c)  Apply 5 µl of each solution.

(d)  Develop the plate to 15 cm.

(e)  After removal of the plate, dry in air and examine under ultraviolet light (254  nm). Expose the plate to nitrous fumes in a closed glass tank for 15  minutes (the nitrous fumes may be generated by adding 100  ml of 1m hydrochloric acid to 6.9  g of sodium nitrite). Place the plate in a current of warm air for 15  minutes and spray with a 0.5% w/v solution of N-(1-naphthyl) ethylenediamine dihydrochloride in ethanol (50%) containing 1% v/v of 1m hydrochloric acid.


mobile phase

1  volume of 2m ammonia, 4  volumes of methanol and 5  volumes of chloroform.


limits

By each method of visualisation, any secondary spot in the chromatogram obtained with solution (1) is not more intense than that in the chromatogram obtained with solution (3) (0.5%).


Azo-glutethimide

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

(1)  Add 200  ml of dimethylsulphoxide to a quantity of the powdered tablets containing 0.25  g of Aminoglutethimide, shake for 15  minutes, protected from light, add sufficient dimethylsulphoxide to produce 250  ml and filter.  

(2)  0.00003% w/v of aminoglutethimide impurity D EPCRS in dimethylsulphoxide.


chromatographic conditions 

(a)  Use a stainless steel column (25  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS 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 328 nm.

(f)  Inject 20 µl of each solution.

(g)  Inject dimethylsulphoxide as a blank solution.


mobile phase 

350  volumes of a solution prepared by dissolving 0.285  g of disodium edetate in water, adding 7.5  ml of 2m acetic acid, 50  ml of 0.1m potassium hydroxide and sufficient water to produce 1000  ml, adjusting the pH to 5.0 with glacial acetic acid and 650  volumes of methanol. Pass the mobile phase through the column until the retention times obtained with solution (2) are constant.


limits 

In the chromatogram obtained with solution (1):

the area of any peak corresponding to aminoglutethimide impurity D is not greater than the area of the peak in the chromatogram obtained with solution (2) (300  ppm).












Assay

Weigh and powder 20  tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. 

(1)  Add 75  ml of methanol to a quantity of the powdered tablets containing 0.5  g of Aminoglutethimide, shake for 30  minutes, dilute to 100  ml with methanol, centrifuge and dilute 10  ml of the clear supernatant liquid to 100  ml with water.

(2)  Dilute 1  volume of a 0.5% w/v solution of aminoglutethimide BPCRS in methanol to 10  volumes with water.  

(3)  Dilute 1  volume of a 0.5% w/v solution of aminoglutethimide BPCRS in methanol to 100  volumes with methanol and mix 1  volume of this solution and 1  volume of a 0.005% w/v solution of aminoglutethimide impurity A EPCRS in methanol to 10  volumes with water.


chromatographic conditions 

(a)  Use a stainless steel column (25  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (10 µm) (Nucleosil C18 is suitable).

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

(c)  Use a flow rate of 1.5  ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 254 nm.

(f)  Inject 20 µl of each solution.


mobile phase 

0.5  volume of triethylamine, 160  volumes of acetonitrile and 800  volumes of water.


system suitability

The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 1.0.


determination of content 

Calculate the content of C13H16N2O2 in the tablets using the declared content of C13H16N2O2 in aminoglutethimide BPCRS.

Storage


Aminoglutethimide Tablets should be protected from light and moisture and stored at a temperature not exceeding 30°.




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.

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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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