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High Quality USP/EP/BP GMP DMF FDA Orodispersible Mirtazapine Tablets CAS NO Producer

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Price: $ 0.08 / Tablet
Quantity:
min order: 1 Tablet
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ258
  • Dideu
  • China
  • Orodispersible Mirtazapine 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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Orodispersible Mirtazapine Tablets 

Action and use

Inhibitor of 5HT and noradrenaline reuptake; antidepressant.

Definition

Orodispersible Mirtazapine Tablets contain Mirtazapine in a suitable orodispersible basis.

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

Content of mirtazapine, C17H19N3

95.0  to 105.0% of the stated amount.
Identification

Mix a quantity of the orodispersible tablets containing 50  mg of Mirtazapine with 12.5 ml of water, add 12.5  ml of n-hexane. Allow to separate, retain and filter the hexane layer and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of mirtazapine (RS 434).

Tests

Dissolution

Comply with 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 900 ml of 0.1m hydrochloric acid, 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 the mobile phase if necessary, to produce a solution expected to contain 0.0017%  w/v of Mirtazapine.

(2)  0.0017%  w/v of mirtazapine BPCRS in 0.1m hydrochloric acid.


chromatographic conditions

(a)  Use a stainless steel column (25  cm  ×  4  mm) packed with base-deactivated, end-capped octadecylsilyl silica gel for chromatography (5 µm) (Hypersil BDS C18 is suitable).

(b)  Use isocratic elution and the mobile phase described below.

(c)  Use a flow rate of 1.5  ml per minute.

(d)  Use a column temperature of 40°.

(e)  Use a detection wavelength of 292  nm.

(f)  Inject 50 µl of each solution.


mobile phase

20  volumes of acetonitrile and 80  volumes of a solution, previously adjusted to pH 3.0 with dilute orthophosphoric acid, containing 2  volumes of triethylamine and 1000 volumes of a 0.68% w/v solution of potassium dihydrogen orthophosphate.


determination of content 

Calculate the total content of mirtazapine, C17H19N3, in the medium from the chromatograms obtained and using the declared content of C17H19N3 in mirtazapine BPCRS.


limits

The amount of mirtazapine 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 a mixture of 50 volumes of acetonitrile and 50 volumes of water.


(1)  Shake with the aid of ultrasound a quantity of the powdered tablets containing 30  mg of Mirtazapine with 10  ml of a mixture of 50 volumes of acetonitrile and 50 volumes of water, dilute to 20  ml with a mixture of 50  volumes of acetonitrile and 50  volumes of water and filter.

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

(3)  0.15%  w/v of mirtazapine for system suitability EPCRS.

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


chromatographic conditions 

(a)  Use a stainless steel column (25  cm  ×  4.6  mm) packed with end-capped 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 1.5 ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 240 nm.

(f)  Inject 10 µl of each solution.


mobile phase 

75  volumes of tetrahydrofuran for chromatography, 125  volumes of methanol, 150  volumes of acetonitrile and 650  volumes of a solution, previously adjusted to pH 7.4 with orthophosphoric acid, containing 1.8%  w/v of tetramethylammonium hydroxide.


When the chromatograms are recorded using the prescribed conditions the retention time of mirtazapine is about 16 minutes. The retention times relative to mirtazapine are: impurity  A, about  0.2; impurity  B, about  0.3; impurity  C, about  0.35; impurity  D, about  0.4; impurity  E, about  1.3; impurity  F, about  1.35.


system suitability 

The test is not valid unless:


in the chromatogram obtained with solution (3), the resolution factor between the peaks due to impurities E and F is at least 1.5;


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


limits 

Identify any peaks in the chromatogram obtained with solution (1) corresponding to impurities A, B and F using solution (3) and multiply the areas of these peaks by the corresponding correction factors; impurity A, 1.3; impurity B, 1.3; impurity F, 0.2.


In the chromatogram obtained with solution (1):


the area of any peak corresponding to impurity A is not more than 0.3 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);


the area of any peak due to impurity B is not more than 0.2 times the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);


the area of any peak due to impurity F is not more than 0.2 times the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);


the area of any other secondary peak is not more than 0.2 times the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);


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


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

Assay

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


(1)  Shake a quantity of the powdered tablets containing 90  mg of Mirtazapine with 50  ml of a mixture of 50 volumes of acetonitrile and 50 volumes of water and add sufficient of a mixture of 50 volumes of acetonitrile and 50 volumes of water to produce 100  ml. Filter the solution and dilute 1  volume of the filtrate to 10  volumes with a mixture of 50 volumes of acetonitrile and 50 volumes of water.


(2)  0.009%  w/v of mirtazapine BPCRS in a mixture of 50 volumes of acetonitrile and 50 volumes of water.


chromatographic conditions 

The chromatographic procedure described under Related substances may be used with a detection wavelength of 290 nm.


system suitability 

The test is not valid unless, in the chromatogram obtained with solution (2) the symmetry factor of the peak corresponding to mirtazapine is less than 2.0.


determination of content 

Calculate the total content of mirtazapine, C17H19N3, in the tablets from the chromatograms obtained and using the declared content of C17H19N3 in mirtazapine BPCRS.

Impurities

A.  (14bRS)-2-methyl-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine 2-oxide,

B.  [2-[(2RS)-4-methyl-2-phenylpiperazin-1-yl]pyridin-3-yl]methanol,

C.  (14bRS)-2-methyl-3,4,10,14b-tetrahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepin-1(2H)-one,

D.  (14bRS)-1,2,3,4,10,14b-hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine,

E.  (2RS)-4-methyl-1-(3-methylpyridin-2-yl)-2-phenylpiperazine,

F.  (14bRS)-2-methyl-1,3,4,14b-tetrahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepin-10(2H)-one.




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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