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High Quality USP/EP/BP GMP DMF FDA Co-codamol Capsules CAS NO Producer

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  • AZ401
  • Dideu
  • China
  • Co-codamol 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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Co-codamol Capsules 

Action and use

Opioid analgesic + analgesic; antipyretic.

Definition

Co-codamol Capsules contain Codeine Phosphate and Paracetamol.


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

Content of codeine phosphate, C18H21NO3,H3PO4,½H2O

95.0  to 105.0% of the stated amount.
Content of paracetamol, C8H9NO2

95.0  to 105.0% of the stated amount.

Identification

A.  Shake a quantity of the contents of the capsules containing 0.5  g of Paracetamol with 20  ml of acetone, 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 (RS 258).


B.  Carry out the method for thin-layer chromatography, Appendix III A, using a silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable) and a mixture of 1  volume of 13.5m ammonia, 10  volumes of methanol and 90  volumes of dichloromethane as the mobile phase. Apply separately to the plate 10 µl of each of the following solutions. For solution (1) shake a quantity of the contents of the capsules containing 24  mg of Codeine Phosphate with 30  ml of water for 1  minute and centrifuge. Decant, add 10  ml of 1m sodium hydroxide and 30  ml of dichloromethane to the supernatant liquid, shake for 1  minute and filter the dichloromethane layer through glass-fibre paper (Whatman GF/C is suitable). Solution (2) contains 0.08% w/v of codeine phosphate BPCRS in methanol (50%). Solution (3) contains 0.08% w/v of codeine phosphate BPCRS and dihydrocodeine tartrate BPCRS in methanol (50%). After removal of the plate, allow it to dry in air, spray with ethanolic iron(iii) chloride solution and heat at 105° for 10  minutes. The principal spot in the chromatogram obtained with solution (1) corresponds in position and colour to that in the chromatogram obtained with solution (2). The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots of different colours.


C.  In the Assay for codeine phosphate, the chromatogram obtained with solution (2) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (1).

Tests

Dissolution 

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules with respect to the content of Paracetamol, Appendix XII B1, using Apparatus 2. Use as the medium 900  ml of phosphate buffer pH 5.8 and rotate the paddle at 50 revolutions per minute. Withdraw a sample of 20  ml of the medium and filter. Dilute the filtrate with 0.1m sodium hydroxide 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. 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. Solution (1) contains 0.001% w/v of 4-aminophenol in the mobile phase. For solution (2) shake a quantity of the contents of the capsules containing 0.5  g of Paracetamol with 50  ml of the mobile phase for 10  minutes and filter.


The chromatographic procedure may be carried out using (a) a stainless steel column (20  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (10 µm) (Nucleosil C18 is suitable), (b) 0.01m sodium butanesulphonate in a mixture of 0.4  volume of formic acid, 15  volumes of methanol and 85  volumes of water as the mobile phase with a flow rate of 2  ml per minute and (c) a detection wavelength of 272  nm.


In the chromatogram obtained with solution (2) the area of any peak corresponding to 4-aminophenol is not greater than the area of the principal peak in the chromatogram obtained with solution (1) (0.1%). In the chromatogram obtained with solution (2) peaks with a long retention time may occur due to excipients.


Related substances

A.  Carry out the method for thin-layer chromatography, Appendix III A, using silica gel G as the coating substance and a mixture of 6  volumes of 13.5m ammonia, 30  volumes of cyclohexane and 72  volumes of absolute ethanol as the mobile phase. Apply separately to the plate 20 µl of each of the following solutions. For solution (1) shake a quantity of the contents of the capsules containing 50  mg of Codeine Phosphate with 50  ml of 0.1m hydrochloric acid for 10  minutes and filter. Make the filtrate alkaline with 5m sodium hydroxide and extract with two 40  ml quantities of dichloromethane. Wash the combined extracts with 10  ml of water, filter through a layer of anhydrous sodium sulphate on an absorbent cotton plug moistened with dichloromethane, evaporate the filtrate to dryness at a temperature not exceeding 45° using a rotary evaporator and dissolve the residue in 2  ml of dichloromethane. For solution (2) dilute 1.5  volumes of solution (1) to 100  volumes with dichloromethane. For solution (3) dilute 1  volume of solution (1) to 100  volumes with dichloromethane. After removal of the plate, allow it to dry in air and spray with potassium iodobismuthate solution. Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (1.5%) and not more than one such spot with an Rf value higher than that of the principal spot is more intense than the spot in the chromatogram obtained with solution (3) (1%).


B.  Carry out the method for thin-layer chromatography, Appendix III A, using silica gel GF254 as the coating substance and a mixture of 10  volumes of toluene, 25  volumes of acetone and 65  volumes of dichloromethane as the mobile phase. Pour the mobile phase into an unlined tank, immediately place the prepared plate in the tank, close the tank and allow the solvent front to ascend 14  cm above the line of application. Apply separately to the plate 200 µl of solution (1) and 40 µl of each of solutions (2), (3) and (4). For solution (1) transfer a quantity of the contents of the capsules 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. For solution (2) dilute 1  ml of solution (1) to 10  ml with ethanol (96%). Solution (3) contains 0.0050% w/v of 4′-chloroacetanilide in ethanol (96%). For solution (4) dissolve 0.25  g of 4′-chloroacetanilide and 0.10  g of paracetamol in sufficient ethanol (96%) to produce 100  ml. After removal of the plate, dry it in a current of warm air and examine under ultraviolet light (254  nm). Any spot corresponding to 4′-chloroacetanilide in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (3) (0.005%). Any secondary spot in the chromatogram obtained with solution (2) 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%). 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.


Uniformity of content

Capsules containing less than 2% of Codeine Phosphate comply with the requirements stated under Capsules, with respect to the content of Codeine Phosphate, using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.004% w/v of codeine phosphate BPCRS in the mobile phase. For solution (2) add 100  ml of the mobile phase to the contents of the capsules and mix with the aid of ultrasound until completely dispersed. Shake for 10  minutes, dilute to 200  ml with the mobile phase, filter through a glass-fibre filter (Whatman GF/C is suitable) and use the filtrate.


The chromatographic procedure may be carried out using (a) a stainless steel column (10  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 is suitable), (b) as the mobile phase with a flow rate of 1.5  ml per minute 0.01m sodium pentanesulphonate in a mixture of 22  volumes of methanol and 78  volumes of water, the pH of the solution being adjusted to 2.8 using 2m hydrochloric acid, and (c) a detection wavelength of 220  nm.


Calculate the content of C18H21NO3,H3PO4,½H2O in each capsule using the declared content of C18H21NO3,H3PO4,½H2O in codeine phosphate BPCRS.

Assay

For codeine phosphate

Weigh the contents of 20  capsules. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.004% w/v of codeine phosphate BPCRS in the mobile phase. For solution (2) shake a quantity of the contents of the capsules containing 8  mg of Codeine Phosphate with 100  ml of the mobile phase for 10  minutes, dilute to 200  ml with the same solvent, filter through a glass-fibre filter (Whatman GF/C is suitable) and use the filtrate.


The chromatographic conditions described under Uniformity of content may be used.


Calculate the content of C18H21NO3,H3PO4,½H2O using the declared content of C18H21NO3,H3PO4,½H2O in codeine phosphate BPCRS.


For paracetamol

Weigh the contents of 20  capsules. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.005% w/v of paracetamol BPCRS in the mobile phase. For solution (2) shake a quantity of the contents of the capsules containing 500  mg of Paracetamol with 100  ml of the mobile phase for 10  minutes, dilute to 200  ml with the same solvent, filter through a glass-fibre filter (Whatman GF/C is suitable) and dilute 5  ml of the filtrate to 250  ml with the mobile phase.


The chromatographic conditions described under Uniformity of content may be used but with a detection wavelength of 243  nm.


Calculate the content of C8H9NO2 using the declared content of C8H9NO2 in paracetamol BPCRS.

Labelling

The label states the quantities of Codeine Phosphate and of Paracetamol in each capsule.


When Co-codamol Capsules are prescribed or demanded no strength being stated, capsules containing 8  mg of Codeine Phosphate and 500  mg of Paracetamol shall be dispensed or supplied.




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

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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

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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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