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High Quality USP/EP/BP GMP DMF FDA Co-beneldopa Capsules CAS NO Producer

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  • AZ400
  • Dideu
  • China
  • Co-beneldopa Capsules
  • High quality
  • 99.0% Min
  • 99%-101%
  • Capsule
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

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Co-beneldopa Capsules 

Action and use

Dopa decarboxylase inhibitor + dopamine precursor; treatment of Parkinson's disease.

Definition

Co-beneldopa Capsules contain Benserazide Hydrochloride and Levodopa in the proportions, by weight, 1 part benserazide to 4 parts levodopa.


The capsules comply with the requirements stated under Capsules and with the following requirements.

Content of benserazide, C10H15N3O5

95.0  to 105.0% of the stated amount.
Content of levodopa, C9H11NO495.0  to 105.0% of the stated amount.
Identification

A.  Carry out the method for thin-layer chromatography, Appendix III A, protected from light, using a precoated cellulose plate (Merck plates are suitable) and a mixture of 10  volumes of a 10% v/v solution of hydrochloric acid, 20  volumes of water and 70  volumes of propan-2-ol as the mobile phase, but allowing the solvent front to ascend 10  cm above the line of application. Apply separately to the plate 2 µl of each of the following solutions. For solution (1) shake a quantity of the capsule contents containing 0.2  g of Levodopa with 40  ml of 0.1m hydrochloric acid for 10  minutes, filter and use the filtrate. Solution (2) contains 0.5% w/v of levodopa BPCRS in 0.1m hydrochloric acid. Solution (3) contains 0.142% w/v of benserazide hydrochloride BPCRS in 0.1m hydrochloric acid. After removal of the plate, allow it to dry in a current of warm air for 5  minutes, spray with dilute phosphomolybdotungstic reagent, dry in a current of warm air for 30  seconds and spray with a 10% w/v solution of sodium hydroxide. The chromatogram obtained with solution (1) shows two clearly separated spots, the spot with the higher Rf value corresponding to the spot in the chromatogram obtained with solution (2) and the spot with the lower Rf value corresponding to the spot in the chromatogram obtained with solution (3).


B.  In the Assay, the chromatogram obtained with solution (1) exhibits two peaks with the same retention times as those due to benserazide and levodopa in the chromatogram obtained with solution (2).

Tests

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using as the medium 900  ml of 0.1m hydrochloric acid and rotating the basket at 100 revolutions per minute. Withdraw a sample of 10  ml of the medium and filter. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1), use the filtered dissolution medium diluted with the mobile phase to produce a solution expected to contain 0.04  mg of Levodopa per ml. For solution (2) dilute 1  volume of a 0.1% w/v solution of levodopa BPCRS in 0.1m orthophosphoric acid to 25  volumes with the mobile phase.


The chromatographic procedure described under Assay may be used. Disregard the peak due to benserazide.


Calculate the total content of levodopa, C9H11NO4, in the medium using the declared content of C9H11NO4 in levodopa BPCRS.


Related substances

A.  Carry out the method for liquid chromatography, Appendix III D, using the following solutions. The solutions should be prepared in mobile phase that has been cooled to 4° and injected immediately. For solution (1) shake a quantity of the contents of the capsules containing the equivalent of 0.1  g of benserazide with 100  ml of the mobile phase, mix with the aid of ultrasound for 3  minutes, shaking occasionally, and filter through a 0.45-µm filter, discarding the first 5  ml of filtrate. Solution (2) contains 0.0005% w/v of benserazide impurity A EPCRS in the mobile phase. Solution (3) contains 0.0005% w/v of each of benserazide hydrochloride BPCRS and benserazide impurity A EPCRS in the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (12.5  cm × 4  mm) packed with octylsilyl silica gel for chromatography (5 µm) (Lichrospher RP8 is suitable), (b) as the mobile phase with a flow rate of 1.2  ml per minute a mixture prepared by dissolving 4.76  g of potassium dihydrogen orthophosphate in 800  ml of water, adding 200  ml of acetonitrile and 1.22  g of sodium decanesulphonate and adjusting the pH to 3.5 with orthophosphoric acid and (c) a detection wavelength of 220  nm.


Inject 20 µl of each solution. The test is not valid unless, in the chromatogram obtained with solution (3) the resolution factor between the two principal peaks is at least 2.0.


For solution (1) allow the chromatography to proceed for nine times the retention time of benserazide. In the chromatogram obtained with solution (1) the area of any peak corresponding to benserazide impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%), the area of any other secondary peak is not greater than the area of the peak due to benserazide in the chromatogram obtained with solution (3) (0.5%) and the sum of the areas of any such peaks is not greater than twice the area of the peak due to benserazide in the chromatogram obtained with solution (3) (1%). Disregard any peak with an area less than 0.1  times the area of the peak due to benserazide in the chromatogram obtained with solution (3) (0.05%).


B.  Carry out the method for thin-layer chromatography, Appendix III A, using a precoated cellulose plate (Merck plates are suitable) and a mixture of 10  volumes of a 10% v/v solution of hydrochloric acid, 20  volumes of water and 70  volumes of propan-2-ol as the mobile phase. Apply separately to the plate, as bands 20  mm long, 10 µl of each of solutions (1) and (2) and 20 µl of solution (3) and dry in a current of air. Solution (1) should be prepared immediately before use. For solution (1) shake a quantity of the contents of the capsules containing 0.1  g of Levodopa with 10  ml of a mixture of equal volumes of anhydrous formic acid and methanol. For solution (2) dilute 1  volume of solution (1) to 200  volumes with methanol. Solution (3) is a mixture of equal volumes of solution (1) and a solution prepared by dissolving 30  mg of l-tyrosine in 1  ml of anhydrous formic acid and diluting to 100  ml with methanol. After removal of the plate, allow it to dry in a current of warm air, spray with a freshly prepared mixture containing equal volumes of a 10% w/v solution of iron(iii) chloride hexahydrate and a 5% w/v solution of potassium hexacyanoferrate(iii) and examine the plate immediately. Any secondary band in the chromatogram obtained with solution (1) is not more intense than the band in the chromatogram obtained with solution (2) (0.5%). The test is not valid unless the chromatogram obtained with solution (3) shows a distinct band, at a higher Rf value than the principal band, which is more intense than the band in the chromatogram obtained with solution (2).

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) shake a quantity of the mixed contents of 20 capsules containing 0.1  g of Levodopa with 80  ml of 0.1m orthophosphoric acid for 5  minutes, mix with the aid of ultrasound for 30  minutes, cool, add sufficient 0.1m orthophosphoric acid to produce 100  ml and mix. Filter the resulting solution through a 0.45-µm filter (Whatman GF/C is suitable), discarding the first 5  ml of filtrate, and dilute 10  volumes of the filtrate to 100  volumes with the mobile phase. For solution (2) dissolve 28.7  mg of benserazide hydrochloride BPCRS and 0.1  g of levodopa BPCRS in sufficient 0.1m orthophosphoric acid to produce 100  ml, mix and dilute 10  volumes of the resulting solution to 100  volumes with the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm × 4  mm) packed with octylsilyl silica gel for chromatography (5 µm) (Lichrospher RP8 is suitable), (b) as the mobile phase with a flow rate of 1.2  ml per minute a mixture prepared by dissolving 4.76  g of potassium dihydrogen orthophosphate in 800  ml of water, adding 200  ml of acetonitrile and 1.22  g of sodium decanesulphonate and adjusting the pH to 3.5 with orthophosphoric acid and (c) a detection wavelength of 220  nm. Inject 20 µl of each solution.


The chromatogram obtained with solution (2) shows two principal peaks; the retention time of the peak due to benserazide is about three times that of the peak due to levodopa.


Calculate the content of C10H15N3O5 and of C9H11NO4 in each capsule using the declared contents of C10H15N3O5 in benserazide hydrochloride BPCRS and of C9H11NO4 in levodopa BPCRS.

Storage

Co-beneldopa Capsules should protected from moisture.

Labelling

The label states the quantity of Benserazide Hydrochloride, in terms of the equivalent amount of benserazide, and the amount of Levodopa in each capsule.




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.

Capsules 1CapsulesCapsules 106

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.


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I)Pharmaceutical Industries

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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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