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High Quality USP/EP/BP GMP DMF FDA Medroxyprogesterone Tablets CAS NO 520-85-4 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
  • AZ212
  • Dideu
  • 520-85-4
  • C22H32O3
  • 208-298-6
  • China
  • Medroxyprogesterone 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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Medroxyprogesterone Tablets 

Action and use

Progestogen.

Definition

Medroxyprogesterone Tablets contain Medroxyprogesterone Acetate.

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

Content of medroxyprogesterone acetate, C24H34O4 

95.0  to 105.0% of the stated amount.
Identification

Disperse a quantity of the powdered tablets containing 50  mg of Medroxyprogesterone Acetate in 8  ml of petroleum spirit (boiling range, 40° to 60°) and extract with three 8-ml quantities of a mixture of 7  volumes of glacial acetic acid and 3  volumes of water. Wash the combined extracts with 10  ml of petroleum spirit (boiling range, 40° to 60°), dilute with water until the solution becomes turbid, allow to stand in ice for 2  hours and filter. Wash the precipitate with water and dry at 105°. The infrared absorption spectrum , Appendix II A, is concordant with the reference spectrum of medroxyprogesterone acetate (RS  421).

Tests

Related substances

Dissolution

Comply with the dissolution test for tablets and capsules, Appendix XII D, using apparatus 2. Use as the medium 900 ml of 0.5% w/v sodium lauryl sulphate and rotate the paddle at 50 revolutions per minute. Withdraw a sample of the medium and filter. 


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


(1)  To a quantity of the filtrate add sufficient of a solution of 0.5% w/v sodium lauryl sulphate to produce a solution expected to contain 0.0028% w/v of Medroxyprogesterone Acetate.

(2)  0.0028% w/v of medroxyprogesterone acetate BPCRS in a solution of 0.5% w/v sodium lauryl sulphate.


CHROMATOGRAPHIC CONDITIONS

(a)  Stainless steel column (8  cm  ×  4  mm) packed with octylsilyl silica gel for chromatography R1 (10 µm) (Zorbax C8 is suitable)

(b)  Isocratic elution using the mobile phase described below.

(c)  Flow rate of 1.5 ml per minute.

(d)  Ambient column temperature.

(e)  Detection wavelength of 254  nm.

(f)  Injection volume of 20µl for each solution.


mobile phase 

40  volumes of water and 60  volumes of acetonitrile .


DETERMINATION OF CONTENT

Calculate the content of medroxyprogesterone acetate, C24H34O4, in the medium using the declared content of C24H34O4 in medroxyprogesterone acetate BPCRS .


Impurity F (6a-methyl-3,20-dioxo-5b-pregnan-17-yl acetate)

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


(1)  Shake a quantity of powdered tablets containing 0.2  g of Medroxyprogesterone Acetate with dichloromethane , add sufficient dichloromethane to produce 10  ml, centrifuge and use the supernatant liquid.

(2)  2.0%  w/v of medroxyprogesterone acetate for performance test EPCRS (containing 0.5% of impurity  F) in dichloromethane .


CHROMATOGRAPHIC CONDITIONS

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

(b)  10 volumes of tetrahydrofuran , 45  volumes of 1,1-dimethylethyl methyl ether and 45 volumes of hexane as the mobile phase.

(c)  Apply to the plate 10  µl of each of solutions (1) and (2).

(d)  After removal of the plate, allow the plate to dry in air and carry out a second development in the same direction using a freshly prepared mobile phase.

(e)  Dry the plate at 100° to 105° and allow to cool, spray with a 200 g/l solution of toluenesulphonic acid in ethanol (96 per cent) . Heat at 120 °C for 10 min, allow to cool and examine the plate in ultraviolet light 365  nm.


SYSTEM SUITABILITY

The test is not valid unless the chromatogram obtained with solution (2) shows two clearly separated spots.


LIMITS

In the chromatogram obtained with solution (1) any blue fluorescent spot with an Rf value higher than that of the principal spot is not more intense than the corresponding blue fluorescent spot due to impurity  F in the chromatogram obtained with solution  (2)  (0.5%).


Related substances

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

(1)  Shake a quantity of the powdered tablets containing 40  mg of Medroxyprogesterone Acetate with 50  ml of the mobile phase for 15 minutes, add sufficient of the mobile phase to produce 100  ml, mix, filter and use the filtrate.

(2)  Dilute 1  volume of solution  (1) to 100  volumes with the mobile phase.

(3)  0.002% w/v of medroxyprogesterone acetate BPCRS and 0.005% w/v of megestrol acetate BPCRS in the mobile phase.


CHROMATOGRAPHIC CONDITIONS

(a)  Stainless steel column (25 cm × 4.6 mm) packed with base-deactivated end-capped octadecylsilyl silica gel for chromatography (5 µm) (Phenomenex Prodigy ODS3 is suitable).

(b)  Isocratic elution using the mobile phase described below.

(c)  Flow rate of 2 ml per minute.

(d)  Maintain the temperature of the column at 40°.

(e)  Detection wavelength of 241  nm.

(f)  Injection volume of 20  µl for each solution.


mobile phase 

A mixture of 100 volumes of tetrahydrofuran, 350 volumes of acetonitrile, 500 volumes of water and allowed to equilibrate and the volume adjusted to 1000 volumes with water.


SYSTEM SUITABILITY

The test is not valid unless, in the chromatogram obtained with solution (3):


the resolution factor between the two principal peaks is at least 3.3;


the symmetry factor of the peak due to medroxyprogesterone acetate is not more than 1.3.


LIMITS

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%);


the sum of the areas of any such peaks is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (1.5%);


disregard any peaks with an area not greater than 0.05  times the area of the principal peak in solution (2) (0.05%).

Assay

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


(1)  Shake a quantity of the powdered tablets containing 40  mg of Medroxyprogesterone Acetate with 50  ml of the mobile phase for 15  minutes, add sufficient of the mobile phase to produce 100  ml, mix and filter. To 5ml of the filtrate add sufficient of the mobile phase to produce 50  ml.

(2)  0.004% w/v of medroxyprogesterone acetate BPCRS in the mobile phase.

(3)  0.002% w/v of medroxyprogesterone acetate BPCRS and 0.005% w/v of megestrol acetate BPCRS in the mobile phase.


CHROMATOGRAPHIC CONDITIONS


The chromatographic procedure described under Related substances may be used.


SYSTEM SUITABILITY

The test is not valid unless, in the chromatogram obtained with solution (3):


the resolution factor between the two principal peaks is at least 3.3;


the symmetry factor of the peak due to medroxyprogesterone acetate is not more than 1.3.


DETERMINATION OF CONTENT

Calculate the content of medroxyprogesterone acetate, C24H34O4, in the tablets using the declared content of C24H34O4 in medroxyprogesterone acetate BPCRS .

Impurities

A.  6-hydroxy-6-methyl-3,20-dioxopregn-4-en-17-yl acetate (6-hydroxymedroxyprogesterone acetate),

B.  17-hydroxy-6-methylpregn-4-ene-3,20-dione (medroxyprogesterone),

C.  6,17a-dimethyl-3,17-dioxo-D-homoandrost-4-en-17a-yl acetate,

D.  6-methyl-3,20-dioxopregn-4-en-17-yl acetate (6-epimedroxyprogesterone acetate),

E.  6-methylidene-3,20-dioxopregn-4-en-17-yl acetate (6-methylenehydroxyprogesterone acetate),

F.  6-methyl-3,20-dioxo-5-pregnan-17-yl acetate (4,5-dihydromedroxyprogesterone acetate),

G.  6-methyl-3,20-dioxopregna-4,6-dien-17-yl acetate (megestrol acetate).




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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