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High Quality USP/EP/BP GMP DMF FDA Co-codaprin Tablets CAS NO 130320-48-8 Producer

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  • AZ074
  • Dideu
  • 130320-48-8
  • C27H29NO7
  • China
  • Co-codaprin 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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Co-codaprin Tablets

Action and use

Opioid analgesic + antipyretic; analgesic; anti-inflammatory.

Definition

Co-codaprin Tablets contain Codeine Phosphate and Aspirin in the proportions, by weight, 1 part to 50 parts.

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

Content of codeine phosphate, C18H21NO3,H3PO4, ½H2O

90.0  to 110.0% of the stated amount.
Content of aspirin, C9H8O495.0  to 105.0% of the stated amount.
Identification

A.  Boil 1  g of the powdered tablets with 10  ml of 1m sodium hydroxide, cool and filter. Acidify the filtrate with 1m sulphuric acid; a white precipitate is produced. To a solution of the precipitate add iron(iii) chloride solution R1; a deep violet colour is produced.


B.  Shake 1  g of the powdered tablets with a mixture of 20  ml of water and 1  ml of 1m sulphuric acid for 5  minutes and filter. Reserve the residue for test C. The filtrate yields the reactions characteristic of phosphates, Appendix VI. Make the remainder of the filtrate alkaline with 5m ammonia, extract with dichloromethane, separate the dichloromethane layer and evaporate the dichloromethane. Place a small quantity of the residue on the surface of a drop of nitric acid; a yellow, but no red, colour is produced.


C.  Dissolve 0.1  g of the residue obtained in test B in 1  ml of sulphuric acid, add 0.05  ml of iron(iii) chloride solution R1 or 0.05  ml of ammonium molybdate-sulphuric acid solution and warm gently. A bluish violet colour is produced which changes to red on the addition of 0.05  ml of 2m nitric acid.

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 Aspirin, Appendix XII B1, using Apparatus 2. Use as the medium 500  ml of a pH 4.5 buffer prepared by mixing 29.9  g of sodium acetate and 16.6  ml of glacial acetic acid with sufficient water to produce 10  litres and rotate the paddle at 50 revolutions per minute. Withdraw a sample of 20  ml of the medium and filter. Immediately measure the absorbance of the filtrate, Appendix II B, diluted with the dissolution medium if necessary, at 265  nm using dissolution medium in the reference cell. Measure the absorbance of a suitable solution of aspirin BPCRS in the dissolution medium and calculate the total content of aspirin, C9H8O4, in the medium using the declared content of C9H8O4 in aspirin BPCRS.


Foreign alkaloids

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 powdered tablets containing 50  mg of Codeine Phosphate with 50  ml of 0.1m hydrochloric acid, filter and make the filtrate alkaline with 5m sodium hydroxide. Extract with two 40  ml quantities of chloroform and wash the combined extracts with 10  ml of water. Filter through a layer of anhydrous sodium sulphate on an absorbent cotton plug moistened with chloroform. Evaporate the filtrate to dryness and dissolve the residue in 2  ml of chloroform. For solution (2) dilute 1.5  volumes of solution (1) to 100  volumes with chloroform. For solution (3) dilute 1  volume of solution (1) to 100  volumes with chloroform. 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%).


Salicylic acid

To a quantity of the powdered tablets containing 0.50  g of Aspirin add 50  ml of chloroform and 10  ml of water, shake well and allow to separate. Filter the chloroform layer through a dry filter paper and evaporate 10  ml of the filtrate to dryness at room temperature using a rotary evaporator. To the residue add 4  ml of ethanol (96%), stir well, dilute to 100  ml with water at a temperature not exceeding 10°, filter immediately and rapidly transfer 50  ml to a Nessler cylinder. Add 1  ml of freshly prepared ammonium iron(iii) sulphate solution R1, mix and allow to stand for 1  minute. Any violet colour produced is not more intense than that obtained by adding 1  ml of freshly prepared ammonium iron(iii) sulphate solution R1 to a mixture of 3  ml of a freshly prepared 0.050% w/v solution of salicylic acid, 2  ml of ethanol (96%) and sufficient water to produce 50  ml contained in a second Nessler cylinder (3.0%).

Assay

Weigh and powder 20  tablets.


For codeine phosphate

To a quantity of the powder containing 24  mg of Codeine Phosphate add 5  ml of 5m sodium hydroxide and 15  ml of water, shake for 2  minutes and extract with three 50  ml quantities of chloroform. Wash each extract with the same 10  ml of water, filter through absorbent cotton previously moistened with chloroform and evaporate the combined extracts to about 60  ml on a water bath in a current of air. Cool, add 25  ml of water, 5  ml of acetate buffer pH 2.8 and 5  ml of dimethyl yellow and oracet blue B solution and titrate with 0.01m dioctyl sodium sulphosuccinate VS with vigorous swirling until near the end point, then add the titrant drop wise and, after each addition, swirl vigorously, allow to separate and swirl gently for 5  seconds. The end point is indicated by the appearance of a permanent pinkish grey colour in the chloroform layer. Repeat the operation without the powdered tablets. The difference between the titrations represents the amount of dioctyl sodium sulphosuccinate required.


Dissolve 40  mg of codeine phosphate BPCRS in 25  ml of water and 5  ml of acetate buffer pH 2.8, add 60  ml of chloroform and 5  ml of dimethyl yellow and oracet blue B solution, shake well to dissolve the codeine phosphate and carry out the method described above beginning at the words 'and titrate …'. Calculate the content of C18H21NO3,H3PO4,½H2O using the declared content of C18H21NO3,H3PO4,½H2O in codeine phosphate BPCRS.


For aspirin

To a quantity of the powder containing 0.8  g of Aspirin add 20  ml of water and 2  g of sodium citrate and boil under a reflux condenser for 30  minutes. Cool, wash the condenser with 30  ml of warm water and titrate with 0.5m sodium hydroxide VS using phenolphthalein solution R1 as indicator. Each ml of 0.5m sodium hydroxide VS is equivalent to 45.04  mg of C9H8O4.

Storage

Co-codaprin Tablets should be protected from light.

LabellingThe label states (1) that the tablets contain Aspirin, unless this word appears in the name of the tablets (this requirement does not apply in countries where exclusive proprietary rights in the name Aspirin are claimed); (2) the quantities of Codeine Phosphate and of Aspirin 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.

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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