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High Quality USP/EP/BP GMP DMF FDA Desogestrel Tablets CAS NO 54024-22-5 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
  • AZ099
  • Dideu
  • 54024-22-5
  • C22H30O
  • 258-929-4
  • China
  • Desogestrel 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

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Desogestrel Tablets

Action and use Progestogen.

Definition

Desogestrel Tablets contain Desogestrel.

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

Content of desogestrel, C22H30O

90.0  to 105.0% of the stated amount.
Identification

A.  In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as the principal peak in the chromatogram obtained with solution (2).

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


(1)  Disperse a quantity of powdered tablets containing 0.75  mg of Desogestrel in 8 ml of dichloromethane, mix with the aid of ultrasound and dilute to 10  ml with dichloromethane and filter.

(2)  0.0075%  w/v of desogestrel BPCRS.

(3)  0.0075%  w/v each of desogestrel BPCRS and lynestrenol BPCRS.


chromatographic conditions

(a)  Use a silica gel 60 precoated plate for high performance thin-layer chromatography (Merck silica gel 60 HPTLC plates are suitable).

(b)  Use the mobile phase described below. 

(c)  Apply 2  µl of each solution.

(d)  After removal of the plate, dry in air, spray it with ethanolic sulphuric acid (2%), heat at 110° for 10 minutes and examine under ultraviolet light (365 nm).


mobile phase

A mixture of 20  volumes of ethyl acetate and 80  volumes of toluene.


system suitability

The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.


confirmation

The principal spot in the chromatogram obtained with solution (1) is similar in colour, position and size to the principal spot in the chromatogram obtained with solution (2).

Tests

Solution A


80  volumes of acetonitrile and 20  volumes of water.


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 2, rotating the paddle at 50 revolutions per minute.

(b)  Use 500 ml of a 0.3% w/v solution of sodium lauryl sulphate, at a temperature of 37°, as the medium.


procedure

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

(1)  After 45 minutes withdraw a sample of the medium and filter. Use the filtered medium, diluted with a 0.3% w/v solution of sodium lauryl sulphate if necessary, expected to contain 0.000015% w/v of Desogestrel.

(2)  0.000015%  w/v of desogestrel BPCRS in a mixture of 1 volume of 2-propanol and 99 volumes of a 0.3%  w/v solution of sodium lauryl sulphate.


chromatographic conditions

(a)  A stainless steel column (15  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography R (5  µm) (Zorbax ODS 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 a column temperature of 40°C.

(e)  Use a detection wavelength of 205  nm.

(f)  Inject 200 µl of each solution.


mobile phase

5  volumes of water and 95 volumes of acetonitrile.


determination of content

Calculate the content of C22H30O in the medium from the chromatograms obtained and using the declared content of C22H30O in desogestrel BPCRS.


Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions in 80  volumes of acetonitrile and 20  volumes of water (Solution A).


(1)  Disperse a quantity of powdered tablets containing 0.75  mg of Desogestrel in 15  ml of solution A, mix with the aid of ultrasound and dilute with sufficient solution A to produce 20  ml, mix and filter.

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

(3)  0.00375%  w/v of desogestrel BPCRS, 0.000075%  w/v of desogestrel impurity D BPCRS and 0.0000375%  w/v of desogestrel impurity E BPCRS.


chromatographic conditions

(a)  Use a stainless steel column (15  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography R (5  µm) (Zorbax ODS is suitable).

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

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

(d)  Use a column temperature of 40°C.

(e)  Use detection wavelengths of 230  nm and 210  nm.

(f)  Inject 25 µl of each solution.


mobile phase

Mobile Phase A  acetonitrile.


Mobile phase B  50  volumes of acetonitrile and 50 volumes of water.


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system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to desogestrel impurity D and desogestrel is at least 1.5 and the retention time of desogestrel impurity D is not greater than 6  minutes.


limits

In the chromatogram obtained with solution (1) at 210  nm:


the area of any peak due to desogestrel impurity E is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (1%);


the area of any other peak other than the principal peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%).


In the chromatogram obtained with solution (1) at 230  nm:


the area of any peak due to desogestrel impurity D is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (2%).


Uniformity of content

Tablets containing less than 2 mg of Desogestrel comply with the requirements stated under Tablets using the following method of analysis.


Carry out the method for liquid chromatography, Appendix III D, using the following solutions in 80  volumes of acetonitrile and 20  volumes of water (Solution A).


(1)  To one tablet add 5  ml of solution A, mix with the aid of ultrasound and add sufficient solution A to produce a solution expected to contain 0.00075%  w/v of Desogestrel.

(2)  0.00075%  w/v of desogestrel BPCRS.

(3)  0.00075%  w/v of desogestrel BPCRS, 0.000015%  w/v of desogestrel impurity D BPCRS and 0.0000075%  w/v of desogestrel impurity E BPCRS.


chromatographic conditions

The chromatographic procedure described under Related substances may be used with the following amendments:

(a)  Use a detection wavelength of 210  nm.

(b)  Inject 125  µl of each solution.


system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to desogestrel impurity D and desogestrel is at least 1.5 and the retention time of desogestrel impurity D is not greater than 6  minutes. 


determination of content

Calculate the content of C22H30O in the tablets using the declared content of C22H30O in desogestrel BPCRS.

Assay

For tablets containing 2 mg or more of desogestrel

Carry out the method for liquid chromatography, Appendix III D, using the following solutions in 80  volumes of acetonitrile and 20  volumes of water (Solution A).

(1)  To a quantity of powdered tablets containing 0.75  mg of Desogestrel add 10  ml of solution A, mix with the aid of ultrasound and add sufficient solution A to produce 20  ml.

(2)  0.00375%  w/v of desogestrel BPCRS.

(3)  0.00375%  w/v of desogestrel BPCRS, 0.000075%  w/v of desogestrel impurity D BPCRS and 0.0000375%  w/v of desogestrel impurity E BPCRS.


chromatographic conditions

The chromatographic procedure described under Related substances may be used with a detection wavelength of 210  nm.


system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to desogestrel impurity D and desogestrel is at least 1.5 and the retention time of desogestrel impurity D is not greater than 6  minutes.


determination of content

Calculate the content of C22H30O in the tablets using the declared content of C22H30O in desogestrel BPCRS.


For tablets containing less than 2 mg of desogestrel

Use the average of the ten individual results obtained in the test for Uniformity of content.

Impurities

D.  13-ethyl-17-hydroxy-11-methylidene-18,19-dinor-17α-pregn-4-en-20-yn-3-one (European Pharmacopoeia impurity D),

E.  13-ethyl-11-methylidene-18,19-dinor-17α-pregn-4-en-20-yne-3α,17-diol (European Pharmacopoeia impurity E).




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

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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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