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High Quality USP/EP/BP GMP DMF FDA Clonazepam Tablets CAS NO 1622-61-3 Producer

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  • AZ066
  • Dideu
  • 1622-61-3
  • C15H10ClN3O3
  • 216-596-2
  • China
  • Clonazepam 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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Clonazepam Tablets

Action and useBenzodiazepine.

Definition

Clonazepam Tablets contain Clonazepam.

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

Content of clonazepam, C15H10ClN3O3


95.0  to 105.0% of the stated amount.
Identification

Extract a quantity of the powdered tablets containing 10  mg of Clonazepam with 25  ml of dichloromethane, centrifuge, filter the supernatant liquid, evaporate to dryness and dry the residue at 60° at a pressure not exceeding 0.7  kPa. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of clonazepam (RS 432).


Dissolution

Carry out the following procedure protected from light. Comply with the requirements in the dissolution test for tablets and capsules, Appendix XII B1.


test conditions

(a)  Use Apparatus 1, rotating the basket at 100 revolutions per minute.

(b)  Use 900  ml of water, at a temperature of 37°, as the dissolution 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 water if necessary, to produce a solution expected to contain 0.00005% w/v of Clonazepam.

(2)  0.00005%  w/v of clonazepam BPCRS.


chromatographic conditions

(a)  Use a stainless steel column (25 cm × 4.0 mm) packed with octadecylsilyl silica gel for chromatography (5 µm).

(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 254  nm.

(f)  Inject 100  µl of each solution.


mobile phase

30 volumes of acetonitrile, 30 volumes of methanol and 40 volumes of water.


determination of content 

Calculate the total content of clonazepam, C15H10ClN3O3, in the medium from the chromatograms obtained and using the declared content of C15H10ClN3O3 in clonazepam BPCRS.


limits

The amount of clonazepam, C15H10ClN3O3, released is not less than 75% (Q) of the stated amount.

Tests

Related substances

Related substances

Carry out the following procedure protected from light and prepare samples immediately before use. Use low-actinic glassware. Prepare a mixture of 10 volumes of tetrahydrofuran, 42 volumes of methanol and 48 volumes of water (solution A). Carry out the method for liquid chromatography, Appendix  III  D, using the following solutions.


(1)  Shake a quantity of the powdered tablets containing 10  mg of Clonazepam with 1  ml of tetrahydrofuran and 4  ml of methanol, add sufficient water to produce 20  ml, mix and filter.

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

(3)  0.005% w/v each of clonazepam BPCRS and flunitrazepam BPCRS in solution A.

(4)  0.0005% w/v of 3-amino-4-(2-chlorophenyl)-6-nitroquinolin-2(1H)-one BPCRS in solution A.

(5)  Dilute 1 volume of solution (2) to 2 volumes with solution A.


chromatographic conditions

(a)  Use a stainless steel column (15 cm × 3.9 mm) packed with end-capped octylsilyl silica gel for chromatography (5 µm) (Symmetry C8 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 254 nm.

(f)  Inject 20 µl of each solution.

(g)  Allow the chromatography to proceed for 3 times the retention time of clonazepam.

(h)  The retention time of clonazepam is about 7 minutes, the retention time of 3-amino-4-(2-chlorophenyl)-6-nitroquinolin-2(1H)-one is about 14.5 minutes and the retention time of (2-amino-5-nitrophenyl)(2-chlorophenyl)methanone is about 17 minutes. 


mobile phase

48 volumes of a 0.66% w/v solution of diammonium hydrogen orthophosphate, previously adjusted to pH 8.0 with a 4.0% w/v solution of sodium hydroxide or dilute phosphoric acid, 10 volumes of tetrahydrofuran and 42 volumes of methanol.


system suitability

The test is not valid unless:


in the chromatogram obtained with solution (3) the resolution factor between the two principal peaks is not less than 1.8;


in the chromatogram obtained with solution (5) the signal-to-noise ratio of the principal peak is at least 10.


limits

In the chromatogram obtained with solution (1):


the area of any peak corresponding to 3-amino-4-(2-chlorophenyl)-6-nitroquinolin-2(1H)-one is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (1%);


the area of any peak corresponding to (2-amino-5-nitrophenyl)(2-chlorophenyl)methanone is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (1%);


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


The sum of the impurities is not more than 2%.


Disregard any peak with an area less than that of the area of the principal peak in the chromatogram obtained with solution (5) (0.1%).


Uniformity of content

Tablets containing less than 2 mg of Clonazepam or less than 2% w/w of Clonazepam comply with the requirements stated under Tablets using the following method of analysis.


Prepare a mixture of 10 volumes of tetrahydrofuran, 42 volumes of methanol and 48 volumes of water (solution A). Carry out the following procedure protected from light and prepare the solutions immediately before use. Carry out the method for liquid chromatography, Appendix  III  D, using the following solutions in solution A.


(1)  Shake a whole tablet with 1  ml of tetrahydrofuran and 4  ml of methanol, add sufficient water to produce 10  ml, mix and filter. Dilute the filtrate, if necessary with sufficient solution  A to produce a solution expected to contain 0.001% w/v of Clonazepam.

(2)  0.001% w/v of clonazepam BPCRS.

(3)  0.0005% w/v each of clonazepam BPCRS and flunitrazepam BPCRS.


chromatographic conditions

The chromatographic conditions described under Related substances may be used with an injection volume of 100  µl.


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 1.8.


determination of content 

Calculate the content of C15H10ClN3O3 in the tablets from the chromatograms obtained and using the declared content of C15H10ClN3O3 in clonazepam BPCRS.

Assay

For tablets containing 2 mg or more of Clonazepam and 2%  w/w or more of Clonazepam

Prepare a mixture of 10 volumes of tetrahydrofuran, 42 volumes of methanol and 48 volumes of water (solution A). Carry out the following procedure protected from light and prepare the solutions immediately before use. Carry out the method for liquid chromatography, Appendix  III  D, using the following solutions.


(1)  Shake a quantity of the powdered tablets containing 10  mg of Clonazepam with 10  ml of tetrahydrofuran and 40  ml of methanol, add sufficient water to produce 100  ml, mix and filter. 

(2)  0.01% w/v of clonazepam BPCRS in solution A.

(3)  0.005% w/v each of clonazepam BPCRS and flunitrazepam BPCRS in solution A.


chromatographic conditions

The chromatographic conditions 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 1.8.


determination of content 

Calculate the content of C15H10ClN3O3 in the tablets from the chromatograms obtained and using the declared content of C15H10ClN3O3 in clonazepam BPCRS.


For tablets containing less than 2 mg of Clonazepam or less than 2%  w/w of Clonazepam

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


Storage
Clonazepam Tablets should be protected from light.
Impurities

The impurities limited by the requirements of this monograph include:

A.  (2-amino-5-nitrophenyl)(2-chlorophenyl)methanone.

B.  3-amino-4-(2-chlorophenyl)-6-nitroquinolin-2(1H)-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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