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High Quality USP/EP/BP GMP DMF FDA Codergocrine Tablets CAS NO 8067-24-1 Producer

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  • AZ076
  • Dideu
  • 8067-24-1
  • C20H29N3O5S
  • China
  • Codergocrine 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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Codergocrine Tablets

Action and use Vasodilator.

Definition

Codergocrine Tablets contain Codergocrine Mesilate.

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

Content of codergocrine mesilate

90.0  to 110.0% of the stated amount.
Identification

A.  In the Assay, the chromatogram obtained with solution (2) shows four major peaks with retention times corresponding to the peaks due to codergocrine mesilate in the chromatogram obtained with solution (1).


B.  To a quantity of the powdered tablets containing 10  mg of Codergocrine Mesilate add 1  ml of methanol and 5  ml of a 1% w/v solution of (+)-tartaric acid. Stir for 15  minutes and filter through sintered glass (ISO 4793, porosity grade 4, is suitable). To 1  ml of the filtrate add slowly 2  ml of dimethylaminobenzaldehyde solution R6 and mix. A deep blue colour is produced.

Tests

Related substances

Carry out in subdued light the method for thin-layer chromatography, Appendix III A, using a silica gel precoated plate (Merck silica gel 60 plates are suitable), scored at a distance of 15  cm from the line of application, and a freshly prepared mixture of 1  volume of 13.5m ammonia, 3  volumes of methanol, 50  volumes of dichloromethane and 50  volumes of ethyl acetate as the mobile phase. Use an unlined tank closed with an ungreased lid and develop the chromatogram immediately after introducing the mobile phase into the tank. Apply separately to the plate 20 µl of each of the following solutions prepared immediately before use in a mixture of 9  volumes of chloroform and 1  volume of methanol. Solutions (1) and (2) contain 0.0040% w/v and 0.0010% w/v respectively of dihydroergocristine mesilate BPCRS. For solution (3) shake a sufficient quantity of the powdered tablets with the solvent mixture to produce a solution containing 0.20% w/v of Codergrocrine Mesilate, filter and use the filtrate. Allow the solvent front to ascend for exactly 90  minutes, remove the plate and dry it in a current of cold air for not longer than 1  minute. Using a freshly prepared mobile phase, repeat the development for a further 90  minutes, remove the plate and dry it in a current of cold air for not longer than 1  minute. Spray with a 1% w/v solution of dimethylaminobenzaldehyde in a mixture of equal volumes of hydrochloric acid and ethanol (96%), dry in a current of cold air for not longer than 2  minutes and heat at 40° for 15  minutes. In the chromatogram obtained with solution (3), any secondary spot is not more intense than the spot in the chromatogram obtained with solution (1) (2%) and not more than one such spot is more intense than the spot in the chromatogram obtained with solution (2) (0.5%). Disregard any spot remaining on the line of application.


Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, protecting all solutions from light. Use as the medium 500  ml of 0.1m hydrochloric acid and rotate the basket at 120 revolutions per minute. Withdraw a sample of 20  ml of the medium and filter, discarding the first 10  ml of the filtrate. Measure the fluorescence of the solution, Appendix II E, using an excitation wavelength of 285  nm and an emission wavelength of 350  nm using 0.1m hydrochloric acid to set the instrument to zero. Measure the fluorescence of a solution of codergrocrine mesilate BPCRS in 0.1m hydrochloric acid containing the equivalent amount of Codergrocrine Mesilate as that expected in the test solution. Carry out the measurements as quickly as possible.


Calculate the total content of Codergrocrine Mesilate in the medium from the absorbances obtained and using the declared content of codergrocrine mesilate in codergrocrine mesilate BPCRS.


Uniformity of content

Tablets containing less than 2  mg of Codergrocrine Mesilate comply with the requirements stated under Tablets using the following method of analysis. Carry out the following procedure protected from light. Shake one tablet for 30  minutes with sufficient of a 1.0% w/v solution of (+)-tartaric acid to produce a solution containing 0.006% w/v of Codergrocrine Mesilate and filter through sintered glass (ISO 4793, porosity grade 4, is suitable). To 3  ml of the filtrate add 6  ml of dimethylaminobenzaldehyde solution R6, mix, cool to room temperature and allow to stand for exactly 30  minutes. Measure the absorbance of the resulting solution at the maximum at 580  nm, Appendix II B, using in the reference cell a solution prepared by treating 3  ml of a 1.0% w/v solution of (+)-tartaric acid and 6  ml of dimethylaminobenzaldehyde solution R6 in the same manner. Prepare a 0.006% w/v solution of codergrocrine mesilate BPCRS in a 1.0% w/v solution of (+)-tartaric acid; to 3  ml of this solution add 6  ml of dimethylaminobenzaldehyde solution R6 and complete the operation described above, beginning at the words 'mix, cool …'. From the absorbances so obtained, and using the declared content of codergrocrine mesilate in codergrocrine mesilate BPCRS, calculate the content of codergrocrine mesilate in the tablets.


Composition

Using the chromatograms obtained in the Assay calculate the percentage contents of the methanesulphonates of dihydroergocornine, of dihydroergocryptine (α- and β-forms) and of dihydroergocristine with respect to the sum of these components in solution (1), using the products of the molecular weights and peak area figures, and determine the ratio of the peak area of dihydro-α-ergocryptine to that of dihydro-β-ergocryptine. The content of each of dihydroergocornine, dihydroergocryptine and dihydroergocristine is not less than 30.0% and not more than 36.5% of the sum of the three components and the ratio of the peak area of dihydro-α-ergocryptine to that of dihydro-β-ergocryptine is between 1.5 and 2.5.

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Prepare solution (1) in the following manner. Use a sufficient number of whole tablets to produce a final solution containing 0.060% w/v of Codergrocrine Mesilate. Stir the tablets for 15  minutes with 50  ml of a mixture of 2  volumes of a 1.0% w/v solution of (+)-tartaric acid and 1  volume of absolute ethanol, filter through a sintered glass filter (ISO 4793, porosity grade 4, is suitable), wash the filter with three 10  ml quantities of the same solvent mixture and dilute the combined filtrate and washing to 100  ml with the same solvent mixture. Solution (2) contains 0.060% w/v of codergrocrine mesilate BPCRS in a mixture of 2  volumes of a 1% w/v solution of (+)-tartaric acid and 1  volume of absolute ethanol.


The chromatographic procedure may be carried out using (a) a stainless steel column (10  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable), (b) a mixture of 5  volumes of triethylamine, 50  volumes of acetonitrile and 150  volumes of water as the mobile phase with a flow rate of 1.5  ml per minute and (c) a detection wavelength of 280  nm. The components are eluted in the following order: dihydroergocornine, dihydro-α-ergocryptine, dihydroergocristine and dihydro-β-ergocryptine.


The resolution factor between the peaks due to dihydro-α-ergocryptine and dihydroergocristine should be not less than 1.2; this value may be obtained by appropriate adjustment of the acetonitrile content of the mobile phase.


Calculate the content of codergrocrine mesilate in the tablets using the expression:


1


where 

 A1, A2, A3, A4  = the peak areas of the components in order of elution;

 

 M1, M2, M3=the molecular weights of the methanesulphonates of dihydroergocornine, dihydroergocryptine (α-and β-forms) and dihydroergocristine;

 

wR=the percentage w/v of codergrocrine mesilate BPCRS in solution (2) ('R');

 

 wS = the declared content of codergrocrine mesilate in each tablet multiplied by the number of tablets used('S');

 

 pR = the declared content of codergrocrine mesilate in codergrocrine mesilate BPCRS.

Storage
Codergrocrine 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.

2316

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:


I)Pharmaceutical Industries

II)Nutrition Additive Industries

III)Daily-Use Chemical Products Industries & Agrochemicals

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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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