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High Quality USP/EP/BP GMP DMF FDA Doxepin Capsules CAS NO Producer

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Price: $ 0.08 / pcs
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ410
  • Dideu
  • C19H21NO
  • China
  • Doxepin Capsules
  • High quality
  • 99.0% Min
  • 99%-101%
  • Capsule
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

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Doxepin Capsules

Action and use

Monoamine reuptake inhibitor; tricyclic antidepressant.

Definition

Doxepin Capsules contain Doxepin Hydrochloride.


The capsules comply with the requirements stated under Capsules and with the following requirements.

Content of doxepin, C19H21NO

95.0  to 105.0% of the stated amount.

Identification

Wash a quantity of the contents of the capsules containing the equivalent of 0.1  g of doxepin with three 5-ml quantities of petroleum spirit (boiling range, 40° to 60°). Dry in air, extract the residue with three 10-ml quantities of chloroform, evaporate the combined extracts to dryness and dry the residue at 105°. The residue complies with the following tests.


A.  The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of doxepin hydrochloride (RS 117).


B.  Yields reaction A characteristic of chlorides, Appendix VI.

Tests

Related substances

Z-Isomer

13.0  to 18.5%, when determined by the following method. 


Carry out the method for gas chromatography, Appendix III B, using the following solutions. 


(1)  Extract a quantity of the mixed contents of 20 capsules containing the equivalent of 25  mg of doxepin with 5  ml of methanol, centrifuge and use the supernatant liquid. 

(2)  0.5% w/v of doxepin hydrochloride BPCRS in methanol.


chromatographic conditions

(a)  Use a glass column (1.5 m × 4  mm) packed with acid-washed, silanised diatomaceous support (100  to 120  mesh) coated with 3% w/w of cyanopropylmethyl phenyl methyl silicone fluid (OV-225 is suitable).

(b)  Use nitrogen for chromatography as the carrier gas.

(c)  Use an oven temperature maintained at 200°.

(d)  Inject 1  µl of each solution.


determination of content

In the chromatogram obtained with solution (2) a peak due to Z-doxepin immediately precedes, and is adequately separated from, the principal peak which is due to E-doxepin. Measure the areas or heights of the peaks due to Z- and E-isomers in the chromatograms obtained with solutions (1) and (2) and calculate the content of Z-isomer in the substance being examined using the declared content of Z-isomer in doxepin hydrochloride BPCRS.


Related substances (other than the Z-Isomer)

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


solvent A

A mixture of 2 volumes of 2m sodium hydroxide and 1000 volumes of mobile phase.


(1)  Dissolve with the aid of ultrasound a quantity of the contents of the capsules containing the equivalent of 0.1 g of doxepin in 100  ml of solvent A and filter.

(2)  Dilute 1 volume of solution (1) to 100 volumes with solvent A and further dilute 1 volume to 10 volumes with solvent A.

(3)  Dissolve the contents of a vial of doxepin for system suitability EPCRS in 1 ml of the mobile phase.


chromatographic conditions

(a)  Use a stainless steel column (25  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Phenomenex Luna C18 (2) is suitable). 

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

(c)  Use a flow rate of 1  ml per minute.

(d)  Use a column temperature of 30°.

(e)  Use a detection wavelength of 215  nm.

(f)  Inject 20 µl of each solution.

(g)  Identify any peaks corresponding to impurities A, B and C in the chromatogram obtained with solution (3).

(h)  The Z-isomer may appear as a shoulder on the peak due to Doxepin.


mobile phase

20  volumes of acetonitrile, 30  volumes of 0.01m  disodium hydrogen orthophosphate, adjusted to pH 7.7 using 0.02m orthophosphoric acid, and 50 volumes of methanol.


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 C is at least 1.5;


the resolution factor between the peaks due to impurity B and impurity C is at least 1.5.


limits

In the chromatogram obtained with solution (1):


the area of any peak corresponding to impurity A is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);


the area of any peak corresponding to impurity B is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);


the area of any peak corresponding to impurity C is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);


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


the sum of the areas of any other secondary peaks is not greater than 4 times the area of the principal peak in the chromatogram obtained with solution (2) (0.4%);


the sum of the areas of all the peaks is not greater than 10 times the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).

Assay

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


solvent A

A mixture of 2 volumes of 2m sodium hydroxide and 1000 volumes of mobile phase.


(1)  With the aid of ultrasound dissolve a quantity of the contents of the capsules containing the equivalent of 0.1 g of doxepin with 100  ml of solvent A, filter and dilute 1  volume to 10 volumes with solvent A.

(2)  Prepare a solution of doxepin hydrochloride BPCRS containing the equivalent of 0.01% w/v doxepin in solvent A. 

(3)  Dissolve the contents of a vial of doxepin for system suitability EPCRS in 1 ml of 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 peaks due to impurity A and impurity C is at least 1.5;


the resolution factor between the peaks due to impurity B and impurity C is at least 1.5.


determination of content

Calculate the content of C19H21NO in the capsules using the declared content of C19H21NO,HCl in doxepin hydrochloride BPCRS. Each mg of C19H21NO,HCl is equivalent to 0.884g of C19H21NO.

Labelling

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




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.

Capsules 1CapsulesCapsules 106

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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