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High Quality USP/EP/BP GMP DMF FDA Estradiol and Norethisterone Acetate Tablets CAS NO Producer

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  • AZ141
  • Dideu
  • China
  • Estradiol and Norethisterone Acetate 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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Estradiol and Norethisterone Acetate Tablets

Action and use

Estrogen.

Definition

Estradiol and Norethisterone Acetate Tablets contain Estradiol Hemihydrate and Norethisterone Acetate. They are coated.

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

Content of estradiol, C18H24O2 and norethisterone acetate, C22H28O3 

1523

Content of estradiol, C18H24O2 

95.0 to 105.0% of the stated amount.
Content of norethisterone, C20H26O2  95.0 to 105.0% of the stated amount.
Identification

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


(1)  Add 0.2  ml of water to two tablets and shake to disperse. Add sufficient ethanol (96%) to produce a solution containing 0.035%  w/v of Norethisterone Acetate, centrifuge and use the clear supernatant liquid.

(2)  A suitable concentration of estradiol hemihydrate BPCRS and norethisterone acetate BPCRS in ethanol (96%).


chromatographic conditions

(a)  Use as the coating silica gel F254 (Merck silica gel 60 F254 plates are suitable).

(b)  Use the mobile phase as described below. 

(c)  Apply 2  µl of each solution.

(d)  Develop the plate to 15  cm.

(e)  After removal of the plate, dry in air and spray with ethanolic sulphuric acid (5%). Heat the plate at 105° for 15 minutes and examine under ultraviolet light (365 nm).


mobile phase

10 volumes of acetone and 90 volumes of dichloromethane.


system suitability

The test is not valid unless the chromatogram obtained with solution (1) shows two clearly separated spots.


confirmation

The two principal spots in the chromatogram obtained with solution (1) correspond in position and colour to those in the chromatogram obtained with solution (2).


B.  In the test for Uniformity of content, the chromatogram obtained with solution (1) shows two peaks having the same retention times as the peaks due to estradiol and norethisterone acetate in the chromatogram obtained with solution (2).

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 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, to produce a solution expected to contain 0.0001% w/v of estradiol.

(2)  Dissolve sufficient quantities of estradiol hemihydrate BPCRS and norethisterone acetate BPCRS in a 0.3% w/v solution of sodium lauryl sulphate and dilute with a sufficient volume of a 0.3% w/v solution of sodium lauryl sulphate to produce concentrations in the final solution the same as those expected for solution (1).


chromatographic conditions

(a)  Use a stainless steel column (25 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 2 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 235  nm.

(f)  Inject 200 µl of each solution.


mobile phase

450 volumes of water and 550 volumes of acetonitrile.


system suitability

The test is not valid unless, in the chromatogram obtained with solution (2), the resolution factor between each pair of peaks (estradiol and norethisterone, and estrone and norethisterone acetate) is at least 1.0.


determination of content 

Calculate the total content of estradiol, C18H24O2, and of norethisterone acetate, C22H28O3, in the medium using the declared content of C18H24O2 in estradiol hemihydrate BPCRS and the declared content of C22H28O3 in norethisterone acetate BPCRS.


Estrone and norethisterone

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


(1)  Add 20 ml of the mobile phase to a quantity of the powdered tablets containing 5  mg of Estradiol, mix with the aid of ultrasound and add sufficient mobile phase to produce 25 ml. Centrifuge and use the clear supernatant liquid.

(2)  Add 20 ml of the mobile phase to a quantity of the powdered tablets containing 2.5  mg of Norethisterone Acetate, mix with the aid of ultrasound and add sufficient mobile phase to produce 25 ml. Centrifuge and use the clear supernatant liquid.

(3)  0.0001% w/v of estrone BPCRS.

(4)  0.00005% w/v of norethisterone BPCRS.

(5)  0.0017% w/v of estradiol hemihydrate BPCRS, 0.00084% w/v of norethisterone acetate BPCRS, 0.00066% w/v of estrone BPCRS and 0.00034% w/v of norethisterone BPCRS.


chromatographic conditions 

The chromatographic conditions described under Dissolution may be used but injecting 20  µl of each solution.


system suitability

The test is not valid unless, in the chromatogram obtained with solution (5), the resolution factor between each pair of peaks (estradiol and norethisterone, and estrone and norethisterone acetate) is at least 1.0.


limits

In the chromatogram obtained with solution (1) quantify the area of any peak due to estrone using the principal peak in the chromatogram obtained with solution (3).


In the chromatogram obtained with solution (2) quantify the area of any peak due to norethisterone using the principal peak in the chromatogram obtained with solution (4).

1524


Uniformity of content

Tablets containing less than 2 mg of Estradiol or less than 2 mg of Norethisterone Acetate 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.


(1)  Add 20 ml of the mobile phase to one tablet, mix with the aid of ultrasound, cool, add sufficient of the mobile phase to produce 25 ml and centrifuge. Dilute the supernatant liquid if necessary, with the mobile phase to produce a solution containing the equivalent of 0.002% w/v of estradiol.

(2)  Dissolve sufficient quantities of estradiol hemihydrate BPCRS and norethisterone acetate BPCRS in the mobile phase and dilute with sufficient mobile phase to produce concentrations in the final solution the same as those expected for solution (1).

(3)  0.0017% w/v of estradiol hemihydrate BPCRS, 0.00084% w/v of norethisterone acetate BPCRS, 0.00066% w/v of estrone BPCRS and 0.00034% w/v of norethisterone BPCRS in the mobile phase.


chromatographic conditions 

The chromatographic conditions described under Dissolution may be used but injecting 20  µl of each solution.


system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between each pair of peaks (estradiol and norethisterone, and estrone and norethisterone acetate) is at least 1.0.


determination of content 

Calculate the content of C18H24O2 and of C22H28O3 in each tablet using the declared content of C18H24O2 in estradiol hemihydrate BPCRS and the declared content of C22H28O3 in norethisterone acetate BPCRS. 

Assay

For estradiol

For tablets containing less than 2 mg or 2% w/w of estradiol


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


For tablets containing 2 mg or more or 2% w/w or more of estradiol


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


(1)  Add 50 ml of the mobile phase to a quantity of powdered tablets containing the equivalent of 10 mg of estradiol, mix with the aid of ultrasound and centrifuge. Dilute 10 ml of the clear supernatant liquid to 100 ml with the mobile phase.

(2)  0.002% w/v of estradiol hemihydrate BPCRS.

(3)  0.0017% w/v of estradiol hemihydrate BPCRS, 0.00084% w/v of norethisterone acetate BPCRS, 0.00066% w/v of estrone BPCRS and 0.00034% w/v of norethisterone BPCRS.


chromatographic conditions 

The chromatographic conditions described under Dissolution may be used but injecting  20 µl of each solution.


system suitability

The test is not valid unless, in the chromatogram obtained with solution (5), the resolution factor between each pair of peaks (estradiol and norethisterone, and estrone and norethisterone acetate) is at least 1.0.


determination of content 

Calculate the content of C18H24O2 in each tablet using the declared content of C18H24O2 in estradiol hemihydrate BPCRS. 


For norethisterone acetate

For tablets containing less than 2 mg or 2% w/w of estradiol


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

Storage

Estradiol and Norethisterone Acetate Tablets should be protected from light.

Labelling

The label states the quantity of estradiol hemihydrate in terms of the equivalent amount of estradiol.

Impurities

The impurities limited by the requirements of this monograph include:


A.  Estrone,


B.  Norethisterone.




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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