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|Action and use|
Paracetamol Tablets contain Paracetamol.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of paracetamol, C8H9NO2
|95.0 to 105.0% of the stated amount.|
Extract a quantity of the powdered tablets containing 0.5 g of Paracetamol with 20 ml of acetone, filter, evaporate the filtrate to dryness and dry at 105°. The residue complies with the following tests.
A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of paracetamol (RS 258).
B. Boil 0.1 g with 1 ml of hydrochloric acid for 3 minutes, add 10 ml of water and cool; no precipitate is produced. Add 0.05 ml of 0.0167m potassium dichromate; a violet colour is produced slowly which does not turn red.
C. Melting point, about 169°, Appendix V A.
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, 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.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Prepare the solutions immediately before use and protect from light. For solution (1) disperse a quantity of powdered tablets containing 0.2 g of Paracetamol in 8 ml of the mobile phase with the aid of ultrasound, add sufficient mobile phase to produce 10 ml, mix well and filter. For solution (2) dilute 1 volume of solution (1) to 20 volumes with mobile phase and dilute 1 volume of this solution to 20 volumes with mobile phase. Solution (3) contains 0.002% w/v each of 4-aminophenol and paracetamol BPCRS in the mobile phase. Solution (4) contains 0.00002% w/v of 4′-chloroacetanilide in the mobile phase.
The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with octylsilyl silica gel for chromatography (5 µm) (Zorbax Rx C8 is suitable), (b) as the mobile phase with a flow rate of 1.5 ml per minute, at a temperature of 35°C, a mixture of 250 volumes of methanol containing 1.15 g of a 40% v/v solution of tetrabutylammonium hydroxide with 375 volumes of 0.05m disodium hydrogen orthophosphate and 375 volumes of 0.05m sodium dihydrogen orthophosphate and (c) a detection wavelength of 245 nm.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 4.0.
Inject solution (1) and allow the chromatography to proceed for 12 times the retention time of the principal peak. In the chromatogram obtained with solution (1) the area of any peak corresponding to 4-aminophenol is not greater than the area of the corresponding peak in solution (3) (0.1%), the area of any peak corresponding to 4′-chloroacetanilide is not greater than the area of the principal peak in solution (4) (10 ppm) and no other impurity is greater than the area of the principal peak obtained with solution (2) (0.25%).
Weigh and powder 20 tablets. Add a quantity of the powder containing 0.15 g of Paracetamol to 50 ml of 0.1m sodium hydroxide, dilute with 100 ml of water, shake for 15 minutes and add sufficient water to produce 200 ml. Mix, filter and dilute 10 ml of the filtrate to 100 ml with water. Add 10 ml of the resulting solution to 10 ml of 0.1m sodium hydroxide, dilute to 100 ml with water and measure the absorbance of the resulting solution at the maximum at 257 nm, Appendix II B. Calculate the content of C8H9NO2 taking 715 as the value of A(1%, 1 cm) at the maximum at 257 nm.
Paracetamol Tablets should be protected from light.
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.
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:
II)Nutrition Additive Industries
III)Daily-Use Chemical Products Industries & Agrochemicals
IV)Environmental Friendly Chemical And Chemurgy 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.