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High Quality USP/EP/BP GMP DMF FDA Co-proxamol Tablets CAS NO 100503-90-0 Producer

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  • AZ084
  • Dideu
  • 100503-90-0
  • China
  • Co-proxamol 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

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Co-proxamol Tablets

Action and use

Opioid analgesic + analgesic; antipyretic.

Definition

Co-proxamol Tablets contain Dextropropoxyphene Hydrochloride and Paracetamol in the proportions, by weight, 1 part to 10 parts.


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

Content of dextropropoxyphene hydrochloride, C22H29NO2,HCl

95.0  to 105.0% of the stated amount.
Content of paracetamol, C8H9NO295.0  to 105.0% of the stated amount.
Identification

A.  Shake a quantity of the powdered tablets containing 0.1  g of Dextropropoxyphene Hydrochloride with 20  ml of 0.1m hydrochloric acid for 5  minutes and filter. To the filtrate add 5  ml of 2m sodium hydroxide, extract with two 25  ml quantities of dichloromethane, wash the combined extracts with 10  ml of water, shake with anhydrous sodium sulphate, filter and evaporate the filtrate to dryness. Dissolve the residue in 2  ml of dichloromethane and add 50  µl, drop wise, onto the surface of a disc prepared from about 0.3  g of potassium bromide, allowing the solvent to evaporate between applications; dry the disc at 50° for 2  minutes. The infrared absorption spectrum of the resulting thin film, Appendix II A, is concordant with the reference spectrum of dextropropoxyphene (RS 091).


B.  Shake a quantity of the powdered tablets containing 0.325  g of Paracetamol with 10  ml of acetone for 5  minutes, filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of paracetamol.

Tests

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in 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 phosphate buffer pH 5.8, at a temperature of 37°, as the medium.


procedure 

After 45 minutes withdraw a 20 ml sample of the medium and filter. Dilute the filtrate with 0.1m sodium hydroxide, if necessary, to give a solution expected to contain about 0.00075%  w/v of paracetamol. Measure the absorbance of this solution, Appendix II B, at the maximum at 257  nm using 0.1m sodium hydroxide in the reference cell.


determination of content 

Calculate the total content of paracetamol, C8H9NO2, in the medium taking 715 as the value of A(1%, 1  cm) at the maximum at 257  nm.


4-Aminophenol

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

(1)  Shake a quantity of the powdered tablets containing 0.5  g of Paracetamol with 50  ml of the mobile phase for 10  minutes and filter.

(2)  0.001% w/v of 4-aminophenol in the mobile phase.


chromatographic conditions 

(a)  Use a stainless steel column (25  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (10 µm) (Nucleosil C18 is suitable).

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

(c)  Use a flow rate of 2  ml per minute.

(d)  Use an ambient column temperature. 

(e)  Use a detection wavelength of 272  nm.

(f)  Inject 20 µl of each solution.


mobile phase 

0.01m sodium butanesulphonate in a mixture of 0.4  volume of formic acid, 15  volumes of methanol and 85  volumes of water.


limit

In the chromatogram obtained with solution (1):


the area of any peak corresponding to 4-aminophenol is not greater than the area of the peak in the chromatogram obtained with solution (2) (0.1%).


Peaks with a long retention time may occur due to excipients.


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

(1)  Shake a quantity of the powdered tablets containing 25  mg of Dextropropoxyphene Hydrochloride with 5  ml of acetonitrile for 2  minutes, add 5  ml of water, shake for a further 5  minutes, dilute to 25  ml with water, mix and filter (Whatman GF/F filter paper is suitable).

(2)  0.0005% w/v of 4-dimethylamino-3-methyl-1,2-diphenylbutan-2-ol hydrochloride BPCRS and 0.0005% w/v of (1S,2R)-1-benzyl-3-dimethylamino-2-methyl-1-phenylpropyl acetate BPCRS in a mixture of 1  volume of acetonitrile and 4  volumes of water.


chromatographic conditions 

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

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

(c)  Use a flow rate of 2  ml per minute.

(d)  Use an ambient column temperature. 

(e)  Use a detection wavelength of 215  nm.

(f)  Inject 20 µl of each solution. 

(g)  The peaks, in order of emergence, are due to 4-dimethylamino-3-methyl-1,2-diphenylbutan-2-ol hydrochloride and (1S,2R)-1-benzyl-3-dimethylamino-2-methyl-1-phenylpropyl acetate.


mobile phase

40  volumes of acetonitrile and 60  volumes of 0.2m sodium perchlorate, previously adjusted to pH 2.0 using 7m hydrochloric acid.


system suitability 

The test is not valid unless, in the chromatogram obtained with solution (2), the resolution factor between the two peaks is at least 1.5.


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


In the chromatogram obtained with solution (1):


the areas of any peaks corresponding to 4-dimethylamino-3-methyl-1,2-diphenylbutan-2-ol hydrochloride and (1S,2R)-1-benzyl-3-dimethylamino-2-methyl-1-phenylpropyl acetate are not greater than the areas of the respective peaks in the chromatogram obtained with solution (2) (0.5%).


(1)  Transfer a quantity of the finely-powdered tablets containing 1.0  g of Paracetamol to a ground-glass-stoppered 15  ml centrifuge tube, add 5  ml of peroxide-free ether, shake mechanically for 30  minutes, centrifuge at 1000 revolutions per minute for 15  minutes or until a clear supernatant liquid is obtained and use the supernatant liquid.

(2)  Dilute 1  ml of solution (1) to 10  ml with ethanol (96%).

(3)  0.0050% w/v of 4′-chloroacetanilide in ethanol (96%).

(4)  Dissolve 0.25  g of 4′-chloroacetanilide and 0.10  g of paracetamol in sufficient ethanol (96%) to produce 100  ml.


chromatographic conditions

(a)  Use as the coating silica gel F254.

(b)  Use the mobile phase described below. 

(c)  Apply 200  µl of solution (1) and 40  µl of each of solutions (2), (3) and (4).

(d)  Develop the plate to 14 cm.

(e)  After removal of the plate, dry in air, and examine under ultraviolet light (254  nm).


mobile phase

10  volumes of toluene, 25  volumes of acetone and 65  volumes of chloroform.


system suitability

The test is not valid unless the chromatogram obtained with solution (4) shows two clearly separated principal spots, the spot corresponding to 4′-chloroacetanilide having the higher Rf value.


limits

In the chromatogram obtained with solution (1):


any spot corresponding to 4′-chloroacetanilide is not more intense than the spot in the chromatogram obtained with solution (3) (0.005%).


In the chromatogram obtained with solution (2):


any secondary spot with an Rf value lower than that of 4′-chloroacetanilide is not more intense than the spot in the chromatogram obtained with solution (3) (0.25%).

Assay

Weigh and powder 20  tablets.


For dextropropoxyphene hydrochloride

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


(1)  Disperse a quantity of the powdered tablets containing 32.5  mg of Dextropropoxyphene Hydrochloride in 100  ml of 0.02m hydrochloric acid, mix with the aid of ultrasound for 15  minutes, allow to cool, dilute to 500  ml with a mixture of equal volumes of acetonitrile and 0.02m hydrochloric acid and filter (Whatman GF/C filter is suitable).

(2)  0.0065% w/v of dextropropoxyphene hydrochloride BPCRS in a mixture of 40  volumes of acetonitrile and 60  volumes of 0.02m hydrochloric acid.


chromatographic conditions 

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

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

(c)  Use a flow rate of 2  ml per minute.

(d)  Use an ambient column temperature. 

(e)  Use a detection wavelength of 215  nm.

(f)  Inject 20 µl of each solution. 


mobile phase 

40  volumes of acetonitrile and 60  volumes of 0.2m sodium perchlorate, previously adjusted to pH 2.0 using 7m hydrochloric acid.


system suitability

The test is not valid unless, in the chromatogram obtained with solution (2), the resolution factor between the two peaks is at least 1.5.


determination of content 

Calculate the content of C22H29NO2,HCl in the tablets using the declared content of C22H29NO2,HCl in dextropropoxyphene hydrochloride BPCRS.


For paracetamol

Disperse a quantity of the powdered tablets containing 0.325  g of Paracetamol in 5  ml of water, add 100  ml of methanol and shake. Add 300  ml of water, shake for 5  minutes, allow to cool, dilute to 500  ml with water, mix and filter. Dilute 5  ml of the filtrate to 250  ml with 0.01m sodium hydroxide and measure the absorbance of the resulting solution at the maximum at 257  nm, Appendix II B. Calculate the content of C8H9NO2  in the tablets taking 715 as the value of A(1%, 1  cm) at the maximum at 257  nm.

Storage
Co-proxamol Tablets should be protected from light.
LabellingThe label states the quantities of Dextropropoxyphene Hydrochloride and of Paracetamol in each tablet.




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.

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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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