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|Action and use|
Vitamin A analogue (retinoid); treatment of acne.
Isotretinoin Capsules contain Isotretinoin.
The capsules comply with the requirements stated under Capsules and with the following requirements.
Content of isotretinoin, C20H28O2
|95.0 to 105.0% of the stated amount.|
A. In the test for Related substances, the chromatogram obtained with solution (2) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (4).
B. The light absorption of the final solution obtained in the Assay, Appendix II B, in the range 300 to 400 nm, exhibits a maximum at 356 nm.
Not less than 85% of the stated amount per capsule after 60 minutes. Protect the apparatus from light throughout the determination and flush the apparatus with nitrogen before use. Carry out the test using the apparatus for the disintegration test for tablets and capsules , Appendix XII A1, and 900 ml of 0.1m sodium hydroxide as the dissolution medium. Withdraw a 20-ml sample of the medium, filter immediately through a 0.2-µm filter, discarding the first 5 ml of filtrate, and dilute the filtrate with 0.1m sodium hydroxide to give a solution expected to contain about 0.00025% w/v of Isotretinoin. Measure the absorbance of this solution at 343 nm, Appendix II B, using 0.1m sodium hydroxide in the reference cell. Calculate the total content of isotretinoin, C20H28O2, in the medium taking 1490 as the value of A(1%, 1 cm) at 343 nm and divide the result by 6 to obtain the amount per capsule.
Protect the solutions from light throughout the procedure. Carry out the method for liquid chromatography , Appendix III D, using the following solutions. For solution (1) shake a quantity of the contents of the capsules containing 10 mg of Isotretinoin with 10 ml of a mixture of 20 volumes of 0.1m sodium hydroxide and 80 volumes of absolute ethanol for 10 minutes, treat with ultrasound for 15 minutes and centrifuge for 5 minutes. Mix 5 ml of the supernatant liquid with 7.5 ml of 0.1m hydrochloric acid and extract with two 20-ml quantities of dichloromethane . Filter the combined extracts through phase separating paper (Whatman 1PS is suitable) and wash the filter with 5 ml of dichloromethane . Evaporate the combined filtrate and washing to dryness at 30° under reduced pressure and dissolve the residue in 5 ml of methanol . For solution (2) dilute 1 volume of solution (1) to 100 volumes with methanol . Solution (3) contains 0.002% w/v of tretinoin EPCRS in methanol . Solution (4) contains 0.001% w/v of isotretinoin EPCRS in methanol . Solution (5) contains 0.001% w/v of each of tretinoin EPCRS and isotretinoin EPCRS in methanol .
The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (10 µm) (Spherisorb ODS 2 is suitable), (b) as the mobile phase with a flow rate of 1.4 ml per minute a 0.5% w/v solution of glacial acetic acid in a mixture of methanol and water, the proportions adjusted to give a retention time for tretinoin of about 15 minutes (a mixture of 23 volumes of water and 77 volumes of methanol is usually suitable) and (c) a detection wavelength of 353 nm.
Inject 10 µl of each solution and adjust the sensitivity of the detector so that the height of the principal peak in the chromatogram obtained with solution (3) is at least 70% of the full scale of the recorder.
The test is not valid unless, in the chromatogram obtained with solution (5), the resolution factor between the peaks due to tretinoin and isotretinoin is at least 2.0.
In the chromatogram obtained with solution (1) the area of any peak corresponding to tretinoin is not greater than twice the area of the peak in the chromatogram obtained with solution (3) (4%), the area of any other secondary peak is not greater than the area of the peak in the chromatogram obtained with solution (2) (1%) and the sum of the areas of any such peaks is not greater than 1.5 times the area of the peak in the chromatogram obtained with solution (2) (1.5%).
Carry out the following procedure in subdued light. Slit 10 capsules with a scalpel avoiding loss of the capsule contents, place the capsules in a 500 ml graduated flask washing any material adhering to the scalpel into the flask with 25 ml of dichloromethane per capsule and mix with the aid of ultrasound for 15 minutes. Add sufficient dichloromethane to produce 500-ml, shake for 2 minutes and dilute with a solution prepared by diluting 5 ml of 0.1m hydrochloric acid to 250 ml with ethanol (96%) to produce a solution containing 0.0008% w/v of Isotretinoin. Measure the absorbance of this solution at the maximum at 356 nm, Appendix II B, using the ethanolic hydrochloric acid solution in the reference cell. Calculate the content of C20H28O2 in each capsule taking 1350 as the value of A(1%, 1 cm) at the maximum at 356 nm.
Isotretinoin Capsules 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.
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c) Accept SGS,BV any other third-party inspection before loading.
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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.