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Prolonged-release Propranolol Capsules
|Action and use|
Prolonged-release Propranolol Capsules contain Propranolol Hydrochloride. They are formulated so that the medicament is released over a period of several hours.
A suitable dissolution test is carried out to demonstrate the appropriate release of Propranolol Hydrochloride. The dissolution profile reflects the in vivo performance which in turn is compatible with the dosage schedule recommended by the manufacturer.
The capsules comply with the requirements stated under Capsules and with the following requirements.
Content of propranolol hydrochloride, C16H21NO2,HCl
|92.5 to 107.5% of the stated amount.|
A. The light absorption of the solution obtained in the Assay, Appendix II B, exhibits two maxima, at 290 nm and 319 nm, and a shoulder at 306 nm.
B. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
(1) Shake a quantity of the powdered capsule contents containing 20 mg of Propranolol Hydrochloride with 10 ml of methanol for 5 minutes and filter (Whatman No. 1 paper is suitable).
(2) 0.2% w/v of propranolol hydrochloride in methanol.
(a) Use as the coating silica gel GF254.
(b) Use the mobile phase as described below.
(c) Apply 10 µl of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry in air and examine under ultraviolet light (254 nm).
1 volume of 18m ammonia and 99 volumes of methanol.
The principal spot in the chromatogram obtained with solution (1) corresponds in position to that in the chromatogram obtained with solution (2).
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Add 100 ml of methanol to a quantity of the powdered capsule contents containing 0.1 g of Propranolol Hydrochloride, mix with the aid of ultrasound for 15 minutes, shaking occasionally, filter through a glass-microfibre filter (Whatman GF/C is suitable) and use the filtrate.
(2) 0.1% w/v of propranolol hydrochloride for performance test EPCRS in the mobile phase.
(3) Dilute 1 volume of solution (1) to 500 volumes with the mobile phase.
(a) Use a stainless steel column (20 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS 5µm is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1.8 ml per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 292 nm.
(f) Inject 10 µl of each solution.
(g) For solutions (1) and (3) allow the chromatography to proceed for five times the retention time of the principal peak.
A mixture of 1.15 g of sodium dodecyl sulphate, 10 ml of a mixture of 1 volume of sulphuric acid and 9 volumes of water, 20 ml of a 1.7% w/v solution of tetrabutylammonium dihydrogen orthophosphate, 370 ml of water and 600 ml of acetonitrile, the mixture adjusted to pH 3.3 with 2m sodium hydroxide.
Inject 20 µl of solution (2). The test is not valid unless the chromatogram obtained closely resembles the chromatogram supplied with propranolol hydrochloride for performance test EPCRS.
In the chromatogram obtained with solution (1):
the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.2%);
the sum of the areas of any secondary peaks is not greater than four times the area of the principal peak in the chromatogram obtained with solution (3) (0.8%).
To a quantity of the powdered mixed contents of 20 capsules containing 80 mg of Propranolol Hydrochloride add about 150 ml of methanol, heat to boiling and boil for 2 minutes, remove from the heat, shake for 20 minutes, cool to 20° and add sufficient methanol to produce 200 ml. Filter (Whatman No. 1 paper is suitable), discard the first 20 ml of filtrate, and dilute 10 volumes of the filtrate to 200 volumes with methanol. Measure the absorbance of the resulting solution at the maximum at 290 nm, Appendix II B, using methanol in the reference cell. Calculate the content of C16H21NO2,HCl taking 206 as the value of A(1%, 1 cm) at the maximum at 290 nm.
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.