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High Quality USP/EP/BP GMP DMF FDA Dipipanone and Cyclizine Tablets CAS NO Producer

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  • AZ115
  • Dideu
  • China
  • Dipipanone and Cyclizine 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

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Dipipanone and Cyclizine Tablets

Action and use

Opioid receptor agonist.

Definition

Dipipanone and Cyclizine Tablets contain, in each, 10  mg of Dipipanone Hydrochloride and 30  mg of Cyclizine Hydrochloride.

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

Content of dipipanone hydrochloride, C24H31NO,HCl,H2O

9.0  to 11.0  mg.
Content of cyclizine hydrochloride, C18H22N2,HCl 27.75  to 32.25  mg.
Identification

A.  In the Assay, the chromatogram obtained with solution (3) exhibits two peaks having the same retention times as those due to dipipanone and cyclizine in the chromatogram obtained with solution (1).

B.  Shake a quantity of the powdered tablets containing 60  mg of Cyclizine Hydrochloride with 10  ml of acetone and filter, reserving the filtrate for test C. Add 10  ml of chloroform to the residue, mix with the aid of ultrasound for 2  to 3  minutes, filter and evaporate to dryness. The residue yields reaction A characteristic of chlorides, Appendix VI.

C.  Evaporate the filtrate reserved in test B to dryness. The residue yields reaction A characteristic of chlorides, Appendix VI.

Tests

Related substances

Carry out the method for thin-layer chromatography, Appendix III A, using silica gel G as the coating substance and as the mobile phase the lower layer obtained after shaking together a mixture of 2  volumes of 13.5m ammonia, 8  volumes of methanol and 90  volumes of dichloromethane and allowing the layers to separate. Apply separately to the plate 20 µl of each of the following freshly prepared solutions. For solution (1) shake a quantity of the powdered tablets containing 30  mg of Cyclizine Hydrochloride with 50  ml of a mixture of equal volumes of methanol and dichloromethane, filter, evaporate the filtrate to dryness and dissolve the residue in 3  ml of the same solvent mixture. For solution (2) dilute 1  volume of solution (1) to 200  volumes with methanol. Solution (3) contains 0.0050% w/v of N-methylpiperazine in methanol. Solution (4) contains 0.10% w/v of each of cyclizine hydrochloride BPCRS and hydroxyzine hydrochloride BPCRS in methanol. After removal of the plate, allow it to dry in air and expose to iodine vapour for 10  minutes. Any spot corresponding to N-methylpiperazine in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (3) (0.5%). Any other secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%). The test is not valid unless the chromatogram obtained with solution (4) shows two clearly separated spots.

Assay

Weigh and finely powder 20  tablets. Dissolve 0.5  g of chlorcyclizine hydrochloride BPCRS (internal standard) in sufficient dichloromethane to produce 100  ml (solution A). Carry out the method for gas chromatography, Appendix III B, using the following solutions. For solution (1) add 25  ml of solution A to 0.15  g of cyclizine hydrochloride BPCRS and 50  mg of dipipanone hydrochloride BPCRS and dilute to 50  ml with dichloromethane. For solution (2) add 40  ml of dichloromethane to a quantity of the powdered tablets containing 50  mg of Dipipanone Hydrochloride and mix with the aid of ultrasound for 20  minutes; dilute to 50  ml with dichloromethane and filter. Prepare solution (3) in the same manner as solution (2) but add 25  ml of solution A and 15  ml of dichloromethane in place of the 40  ml of dichloromethane.


The chromatographic procedure may be carried out using a glass column (1.5 m × 4  mm) packed with acid-washed, silanised diatomaceous support (80  to 100  mesh) coated with 3% w/w of silicone grease (Apiezon L is suitable) and 5% w/w of potassium hydroxide and maintained at 250°. In the chromatogram obtained with solution (2) the peaks, in order of emergence, are due to cyclizine, chlorcyclizine and dipipanone.


Calculate the content of C24H31NO,HCl,H2O using the declared content of C24H31NO,HCl,H2O in dipipanone hydrochloride BPCRS and the content of C18H22N2,HCl using the declared content of C18H22N2,HCl in cyclizine hydrochloride BPCRS.




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

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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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