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|Action and use|
Trihexyphenidyl Tablets contain Trihexyphenidyl Hydrochloride.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of trihexyphenidyl hydrochloride, C20H31NO,HCl
|90.0 to 110.0% of the stated amount.|
A. Shake a quantity of the powdered tablets containing Trihexyphenidyl Hydrochloride with 20 ml of water and filter. The filtrate yields a yellow precipitate with picric acid solution R1 and a white precipitate with 5m sodium hydroxide.
B. Carry out the method for thin-layer chromatography, Appendix III A, using silica gel G as the coating substance and a mixture of 90 volumes of chloroform and 10 volumes of methanol 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 powdered tablets with sufficient chloroform to produce a solution containing 0.2% w/v of Trihexyphenidyl Hydrochloride and filter. Solution (2) contains 0.2% w/v of trihexyphenidyl hydrochloride BPCRS in chloroform. After removal of the plate, allow it to dry in air and spray with dilute potassium iodobismuthate solution. The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).
Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) mix a quantity of the powdered tablets containing 50 mg of Trihexyphenidyl Hydrochloride with 10 ml of water, add 10 ml of methanol, disperse with the aid of ultrasound for 5 minutes, shake for 15 minutes, add sufficient methanol to produce 25 ml and filter. For solution (2) dilute 1 volume of solution (1) to 100 volumes with methanol (60%). Solution (3) contains 0.01% w/v of 3-piperidylpropiophenone hydrochloride BPCRS in solution (1).
The chromatographic procedure described under Uniformity of content may be used.
The test is not valid unless the resolution factor between the two principal peaks in the chromatogram obtained with solution (3) is greater than 4.0.
The area of any secondary peak in the chromatogram obtained with solution (1) is not greater than the area of the peak in the chromatogram obtained with solution (2) (1%) and the total area of any secondary peaks is not greater than twice the area of the peak in the chromatogram obtained with solution (2) (2%).
Uniformity of content
Tablets containing 2 mg or less of Trihexyphenidyl Hydrochloride comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.008% w/v of trihexyphenidyl hydrochloride BPCRS and 0.004% w/v of 3-piperidylpropiophenone hydrochloride BPCRS in the mobile phase. For solution (2) add 5 ml of water to one tablet and mix with the aid of ultrasound for 5 minutes or until the tablet is dispersed. Add 10 ml of methanol, shake for 15 minutes, dilute to 25 ml with methanol, mix and filter through a filter with a maximum pore size of 0.2 µm.
The chromatographic procedure may be carried out using (a) a stainless steel column (15 cm × 3.9 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Resolve C18 is suitable), (b) as the mobile phase with a flow rate of 2 ml per minute, a mixture of 800 volumes of acetonitrile, 200 volumes of water and 0.2 volume of triethylamine, the pH of the mixture being adjusted to 4.0 with orthophosphoric acid and (c) a detection wavelength of 210 nm.
The test is not valid unless the resolution factor between the two principal peaks in the chromatogram obtained with solution (1) is greater than 4.0.
Calculate the content of C20H31NO,HCl in each tablet using the declared content of C20H31NO,HCl in trihexyphenidyl hydrochloride BPCRS.
For tablets containing more than 2 mg of trihexyphenidyl hydrochloride
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.02% w/v of trihexyphenidyl hydrochloride BPCRS and 0.01% w/v of 3-piperidylpropiophenone hydrochloride BPCRS in the mobile phase. For solution (2) add 5 ml of water to a quantity of the powdered tablets containing 5 mg of Trihexyphenidyl Hydrochloride and mix with the aid of ultrasound for 5 minutes. Add 10 ml of methanol, shake for 15 minutes, dilute to 25 ml with methanol and filter through a filter with a maximum pore size of 0.2 µm.
The chromatographic procedure described under Uniformity of content may be used.
The assay is not valid unless the resolution factor between the two principal peaks in the chromatogram obtained with solution (1) is greater than 4.0.
Calculate the content of C20H31NO,HCl using the declared content of C20H31NO,HCl in trihexyphenidyl hydrochloride BPCRS.
For tablets containing 2 mg or less of trihexyphenidyl hydrochloride
Use the average of the 10 individual results obtained in the test for Uniformity of content.
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.