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High Quality USP/EP/BP GMP DMF FDA Tibolone Tablets CAS NO 5630-53-5 Producer

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  • AZ359
  • Dideu
  • 5630-53-5
  • C21H28O2
  • 227-069-1
  • China
  • Tibolone 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

Tibolone Tablets 

Definition

Tibolone Tablets contain Tibolone.

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

Content of tibolone, C21H28O2

90.0 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)  Shake a quantity of the powdered tablets containing 5 mg of Tibolone with 5 ml of acetonitrile, centrifuge and use the supernatant liquid.

(2)  0.1% w/v of tibolone BPCRS in acetonitrile.


chromatographic conditions

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

(b)  Use the mobile phase described below. 

(c)  Apply 4 µl of each solution.

(d)  Develop the plate to 15  cm.

(e)  After removal of the plate dry in air, spray with ethanolic sulphuric acid (2%) and heat at 100°  to  105° for 3 minutes. Allow to cool and examine under ultraviolet light (366 nm) and in daylight.


mobile phase

5 volumes of acetone and 95 volumes of dichloromethane.


confirmation

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


B.  In the test for Uniformity of content, the chromatogram obtained with solution (1) exhibits a peak with the same retention time as the peak due to tibolone in the chromatogram obtained with solution (2).

Tests

Related substances

Dissolution

Comply with the requirements 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 0.25 %  w/v solution of sodium lauryl sulfate, 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 0.25% w/v solution of sodium lauryl sulfate to produce a solution expected to contain about 0.0005% w/v of Tibolone.

(2)  0.0005% w/v of tibolone BPCRS in a mixture of 1 volume of methanol and 99 volumes of 0.25%  w/v solution of sodium lauryl sulphate.


chromatographic conditions

(a)  A stainless steel column (10 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 0.5  ml per minute.

(d)  Use a column temperature of 40°.

(e)  Use a detection wavelength of 205  nm.

(f)  Inject 200 µl of each solution.


mobile phase

23 volumes of water and 77 volumes of methanol R2.


determination of content 

Calculate the total content of tibolone, C21H28O2, in the medium from the chromatograms obtained and using the declared content of C21H28O2 in tibolone BPCRS.


limits

The amount of tibolone released is not less than 75% (Q) of the stated amount.


Related substances

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


(1)  To a quantity of the powdered tablets containing 25 mg of Tibolone add 40  ml of absolute ethanol, mix with the aid of ultrasound, add sufficient absolute ethanol to produce 50 ml and centrifuge and use the supernatant.

(2)  Dilute 1 volume of solution (1) to 100 volumes.

(3)  0.05%  w/v of tibolone impurity standard BPCRS.

(4)  Dilute 1 volume of solution (2) to 10  volumes.


chromatographic conditions 

(a)  Use a stainless steel column (15  cm  ×  3.9  mm) packed with octadecylsilyl silica gel for chromatography (4 µm) (Nova-Pak C18 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 205 nm.

(f)  Inject 10 µl of each solution.


mobile phase 

28  volumes of tetrahydrofuran and 72  volumes of water.


system suitability 

The test is not valid unless:


in the chromatogram obtained with solution (3), the resolution factor between the peaks due to impurity A and impurity B is at least 2.0;


the chromatogram obtained with solution (3) closely resembles the chromatogram supplied with tibolone impurity standard BPCRS;


in the chromatogram obtained with solution (4), the signal-to-noise ratio of the peak due to tibolone is at least 10.


limits 

Identify any peaks in the chromatogram obtained with solution (1) corresponding to impurities A, B and C and multiply the areas of these peaks by the corresponding correction factors; impurity A, 1.7; impurity B, 1.5; impurity C, 2.1.


In the chromatogram obtained with solution (1):


the area of any peak corresponding to impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);


the area of any peak corresponding to impurity B is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);


the area of any peak corresponding to impurity C is not greater than five times the area of the principal peak in the chromatogram obtained with solution (2) (5%);


the area of any other secondary peak is not greater than 0.5  times the area of the principal peak in the chromatogram obtained with solution (2)  (0.5%);


the sum of the areas of any secondary peaks is not greater than 6.5 times the area of the principal peak in the chromatogram obtained with solution (2) (6.5%).


Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%).


Uniformity of content

For tablets containing 2  mg or less or 2%  w/w or less of tibolone

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


(1)  Finely crush one tablet, moisten the powdered tablet with sufficient absolute ethanol to produce a solution containing 0.05% w/v of Tibolone, disperse with the aid of ultrasound for 10 minutes and centrifuge.

(2)  0.05% w/v of tibolone BPCRS.

(3)  0.05%  w/v of tibolone impurity standard 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 impurity A and impurity B is at least 2.0;


the chromatogram obtained with solution (3) closely resembles the chromatogram supplied with tibolone impurity standard BPCRS.


determination of content 

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

Assay

For tablets containing 2  mg or less or 2%  w/w or less of tibolone

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


For tablets containing more than 2  mg and more than 2%  w/w of tibolone

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


(1)  To a quantity of the powdered tablets containing 25 mg of Tibolone add 40  ml of absolute ethanol, mix with the aid of ultrasound, add sufficient absolute ethanol to produce 50  ml and centrifuge.

(2)  0.05% w/v of tibolone BPCRS.

(3)  0.05%  w/v of tibolone impurity standard 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 impurity A and impurity B is at least 2.0;


the chromatogram obtained with solution (3) closely resembles the chromatogram supplied with tibolone impurity standard BPCRS.


determination of content 

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

Impurities

A.  10,17-dihydroxy-7α-methyl-19-nor-10ξ,17α-pregn-4-en-20-yn-3-one (European Pharmacopoeia impurity A),


B.  10-hydroperoxy-17-hydroxy-7α-methyl-19-nor-10ξ,17α-pregn-4-en-20-yn-3-one(European Pharmacopoeia impurity B),


C.  17-hydroxy-7α-methyl-19-nor-10ξ,17α-pregn-4-en-20-yn-3-one (European Pharmacopoeia impurity C).




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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