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High Quality USP/EP/BP GMP DMF FDA Tamoxifen Tablets CAS NO 10540-29-1 Producer

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  • AZ351
  • Dideu
  • 10540-29-1
  • C26H29NO
  • 234-118-0
  • China
  • Tamoxifen 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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Tamoxifen Tablets 

Action and use

Selective estrogen receptor modulator.


Tamoxifen Tablets contain Tamoxifen Citrate.

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

Content of tamoxifen, C26H29NO

90.0  to 110.0% of the stated amount.

A.  To a quantity of the powdered tablets containing the equivalent of 0.1  g of tamoxifen add 20  ml of water, warm, add 2  ml of 5m sodium hydroxide and cool. Extract with two 10-ml quantities of ether, filtering each extract in turn. Combine the ether extracts and evaporate to dryness in a current of nitrogen at room temperature. Dry the residue at a pressure not exceeding 0.7  kPa for 30  minutes. The infrared absorption spectrum of the dried residue, Appendix II A, is concordant with the reference spectrum of tamoxifen (RS 328).

B.  Shake a quantity of the powdered tablets containing the equivalent of 0.1  g of tamoxifen with 10  ml of methanol, filter, evaporate the filtrate to dryness on a water bath and dry the residue at 100° for 30  minutes. Dissolve 10  mg of the dried residue in 4  ml of pyridine, add 2  ml of acetic anhydride and heat on a water bath. A rose-pink to red colour is produced.


Related substances

E-Isomer and other related substances

Carry out the method for liquid chromatography, Appendix III D, protected from light and using the following solutions. For solution (1) to a quantity of the powdered tablets containing the equivalent of 50  mg of tamoxifen, add 35  ml of the mobile phase, mix with the aid of ultrasound for 5  minutes, dilute to 50  ml with the mobile phase, mix, centrifuge and filter the supernatant liquid through a membrane filter with a nominal pore size of 0.45 µm. For solution (2) dilute 1  volume of solution (1) to 100  volumes with the mobile phase. Solution (3) contains 0.15% w/v of tamoxifen citrate for performance test EPCRS in the mobile phase.

The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Columbus C18 is suitable), (b) as the mobile phase with a flow rate of 1.2  ml per minute a mixture of 40  volumes of acetonitrile and 60  volumes of water containing 0.09% w/v of sodium dihydrogen orthophosphate and 0.48% w/v of N,N-dimethyloctylamine, adjusted to pH 3.0 with orthophosphoric acid and (c) a detection wavelength of 240  nm.

Equilibrate the column with the mobile phase at a flow rate of 1.2  ml per minute for 30  minutes.

Adjust the sensitivity of the system so that the height of the peak due to the E-isomer in the chromatogram obtained with solution (3) is not less than 40% of the full scale of the recorder.

Inject 20 µl of each solution. Continue the chromatography for twice the retention time of the tamoxifen peak. The test is not valid unless the chromatogram obtained with solution (3) resembles that of the specimen chromatogram provided with the tamoxifen citrate for performance test EPCRS in that the resolution factor between the peaks due to the E-isomer and to tamoxifen impurity F is at least 3 and there is base-line separation of the peak due to tamoxifen impurity F from the following peak of the principal component.

In the chromatogram obtained with solution (1), the area of any peak due to the E-isomer is not greater than 0.3  times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%) and the sum of the areas of all the secondary peaks apart from any peak due to the E-isomer is not greater than 0.5  times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%). Disregard any peak with a retention time of less than 2.5  minutes and any peak with an area less than 0.05  times the area of the principal peak in the chromatogram obtained with solution (2) (0.05%).


Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using as the medium 1000 ml of 0.02m hydrochloric acid and rotating the basket at 150 revolutions per minute. Withdraw a sample of 5 ml of the medium. Measure the absorbance of the filtered sample, suitably diluted if necessary, at 275 nm, Appendix II B. Calculate the total content of C26H29NO in the medium taking 305 as the value of A(1%, 1 cm) at 275 nm.


Weigh and powder 20  tablets. To a quantity of the powder containing the equivalent of 25  mg of tamoxifen add 100  ml of methanol, shake for 15  minutes and add sufficient methanol to produce 250  ml. Filter, dilute 10  ml of the filtrate to 100  ml with methanol and measure the absorbance of the resulting solution at 275  nm, Appendix II B. Calculate the content of C26H29NO taking 325 as the value of A(1%, 1  cm) at 275  nm.


Tamoxifen Tablets should be protected from light.


The quantity of active ingredient is stated in terms of the equivalent amount of tamoxifen.

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.


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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