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High Quality USP/EP/BP GMP DMF FDA Norgestrel Tablets CAS NO 6533-00-2 Producer

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Price: $ 0.08 / Tablet
Quantity:
min order: 1 Tablet
View wholesale prices
  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ253
  • Dideu
  • 6533-00-2
  • C21H28O2
  • 229-433-5
  • China
  • Norgestrel 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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Mobile:+86-15129568250; Whatsapp: +8615129568250

Norgestrel Tablets 

Action and use

Progestogen.

Definition

Norgestrel Tablets contain Norgestrel. They are coated.

Production

A suitable dissolution test is carried out to demonstrate the appropriate release of norgestrel. 


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

Content of norgestrel, C21H28O2

95.0 to 105.0% of the stated amount.
Identification

A.  Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) to a quantity of the tablets containing 0.15 mg of Norgestrel add 10 ml of methanol (80%), heat on a water-bath at 60° for 10 minutes, shaking occasionally, allow to cool, dilute with methanol (80%) to produce a solution containing 0.00375% w/v of Norgestrel, mix and filter through a membrane with a pore size of 0.45 µm. Solution (2) contains 0.004% w/v of norgestrel BPCRS in methanol (80%). 


The chromatographic procedure may be carried out using (a) a stainless steel column (12.5 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS is suitable), (b) as the mobile phase with a flow rate of 1.5 ml per minute a solution containing equal volumes of methanol and 1% w/v of gamma-cyclodextrin in water and (c) a detection wavelength of 242 nm.


Inject 20 µl of each solution. The test is not valid unless, in the chromatogram obtained with solution (2), the resolution factor between the peaks due to levonorgestrel and dextronorgestrel is at least 1.0.


The two principal peaks in the chromatogram obtained with solution (1) have the same retention times as the peaks due to levonorgestrel and dextronorgestrel in the chromatogram obtained with solution (2). 


B.  In the test for Uniformity of content, 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).

Tests

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) add 5 ml of a mixture of equal volumes of methanol and water to a quantity of the powdered tablets containing 0.15 mg of Norgestrel, mix with the aid of ultrasound for 30 minutes, stir vigorously for 15 minutes, centrifuge and use the supernatant liquid. For solution (2) dilute 1 volume of solution (1) to 100 volumes with a mixture of equal volumes of methanol and water. Solution (3) contains 0.004% w/v each of ethinylestradiol BPCRS and norgestrel BPCRS in a mixture of equal volumes of methanol and water.


The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 2 is suitable) maintained at 30°, (b) as the mobile phase with a flow rate of 1.2 ml per minute a mixture of 100 volumes of methanol, 240 volumes of acetonitrile and 500 volumes of water and (c) a detection wavelength of 220 nm. 


Inject separately 200 µl of each solution. For each solution allow the chromatography to proceed for twice the retention time of norgestrel. 


The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to ethinylestradiol and norgestrel is at least 12.


In the chromatogram obtained with solution (1) the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%) and the sum of the areas of any such peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2%).


Uniformity of content

Tablets containing less than 2 mg of Norgestrel 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. For solution (1) to 1 tablet add 5 ml of the mobile phase, heat on a water bath at 60° for 15 minutes while shaking, disperse with the aid of ultrasound for 5 minutes, centrifuge and use the clear supernatant liquid. Dilute, if necessary, with the mobile phase to produce a solution containing 0.0015% w/v of Norgestrel. Solution (2) contains 0.0015% w/v of norgestrel BPCRS in the mobile phase. 


The chromatographic procedure may be carried out using (a) a stainless steel column (12.5 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS is suitable), (b) as the mobile phase with a flow rate of 1.3 ml per minute a mixture of equal volumes of acetonitrile and water and (c) a detection wavelength of 220 nm.


Inject 25 µl of each solution.


Calculate the content of C21H28O2 in each tablet using the declared content of C21H28O2 in norgestrel BPCRS.

Assay

Use the average of the 10 individual results obtained in the test for Uniformity of content. 




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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