Online

Cart
You are here: Home » Products » Pharmaceutical Ingredient » Anesthetic » High Quality USP/EP/BP GMP DMF FDA Dantrolene Oral Suspension CAS NO 85008-71-5 Producer
Share to:

High Quality USP/EP/BP GMP DMF FDA Dantrolene Oral Suspension CAS NO 85008-71-5 Producer

5 0 Reviews
Price: $ 0.08 / pcs
Quantity:
min order: 1 pcs
View wholesale prices View wholesale prices
  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
sign in to view wholesale price
  • AZ577
  • Dideu
  • 85008-71-5
  • C14H10N4O5
  • China
  • Oral Suspension
  • High quality
  • 99.0% Min
  • 99%-101%
  • Oral Suspension
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

Our Reference Specification, for more details, pls contact us for COA,MSDS and certification:

Email & Skype: support@dideu.com  Telephone:+86-29-89586682

Mobile:+86-15129568250; Whatsapp: +8615129568250

Dantrolene Oral Suspension 

Action and use

Skeletal muscle relaxant.

Definition

Dantrolene Oral Suspension is a suspension of Dantrolene Sodium in a suitable flavoured vehicle.

The oral suspension complies with the requirements stated under Oral Liquids, the requirements stated under Unlicensed Medicines and with the following requirements.

Content of dantrolene sodium, C14H9N4NaO5,3½H2O 

95.0 to 105.0% of the stated amount.

Identification

A.  Shake a quantity of the oral suspension containing 0.1 g of Dantrolene Sodium with sufficient 0.01m sodium hydroxide to produce 100 ml, dilute 1 ml to 100 ml with 0.01m sodium hydroxide, filter and use the filtrate. The light absorption, Appendix II B, in the range 230 nm to 350 nm, of the final solution, exhibits a maximum at 314 nm.

B.  In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).

Tests

Related substances

Tests

Acidity

pH, 4.5 to 5.5, Appendix V L.

Dissolution

Complies with the requirements stated under Unlicensed Medicines, Oral Suspensions, using 900 ml of 0.1m hydrochloric acid as the dissolution medium and rotating the paddle at 50 revolutions per minute. Use a volume of the oral suspension containing one dose.

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1)  Dissolve a quantity of the oral suspension containing 50  mg of Dantrolene Sodium in 20  ml of tetrahydrofuran and 2 ml of glacial acetic acid and dilute with sufficient absolute ethanol to produce 100 ml. 

(2)  Dilute 1 ml of solution (1) to 100 ml with absolute ethanol. 

(3)  Dissolve 5 mg of dantrolene sodium BPCRS and 0.1 g of theophylline BPCRS in 20 ml of tetrahydrofuran and 2 ml of glacial acetic acid and dilute with sufficient absolute ethanol to produce 100 ml. Further dilute 10 ml of this solution to 100 ml with absolute ethanol.

chromatographic conditions

(a)  Use a stainless steel column (15  cm × 4.6  mm) packed with silica gel for chromatography (5 µm) (Zorbax Sil is suitable).

(b)  Use isocratic elution and the mobile phase described below.

(c)  Adjust the flow rate of the mobile phase so that the retention time of the peak corresponding to Dantrolene Sodium is about 8 minutes.

(d)  Use a column temperature of 30°.

(e)  Use a detection wavelength of 300  nm.

(f)  Inject 10 µl of each solution.

(g)  For solution (1) allow the chromatography to proceed for at least twice the retention time of the principal peak.

mobile phase

9 volumes of absolute ethanol, 10 volumes of glacial acetic acid and 90 volumes of hexane.

system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks corresponding to theophylline and dantrolene is at least 6.

limits

In the chromatogram obtained with solution (1):

the total area of all the secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%).

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1)  Add 50 ml of dimethylformamide to a weighed quantity of the oral suspension containing 60 mg of Dantrolene Sodium and dilute 1 volume of this solution to 100 volumes with the mobile phase.

(2)  Dilute 1 volume of a 0.12% w/v solution of dantrolene sodium BPCRS in dimethylformamide to 100 volumes with the mobile phase.

chromatographic conditions

(a)  Use a stainless steel column (15 cm × 4.6 mm) packed with spherical particles of silica, 5 µm in diameter, the surface of which has been modified with chemically-bonded nitrile groups (Spherisorb CN is suitable).

(b)  Use isocratic elution and the mobile phase described below.

(c)  Use a flow rate of 1 ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 262 nm.

(f)  Inject 20 µl of each solution.

mobile phase

15 volumes of acetonitrile and 85 volumes of a phosphate buffer pH 6.8 prepared by dissolving 11.88 g of disodium hydrogen orthophosphate and 9.08 g of potassium dihydrogen orthophosphate in 1000 ml of water.

determination of content

Determine the weight per ml of the oral suspension, Appendix V G, and calculate the content of C14H9N4NaO5,3½H2O, weight in volume, using the declared content of C14H9N4NaO5 in dantrolene sodium BPCRS. Each mg of C14H9N4NaO5 is equivalent to 1.1873 mg of C14H9N4NaO5,3½H2O.

StorageDantrolene Oral Suspension 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.

Oral Suspension 1Oral Suspension 15Oral Suspension 46

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

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.


Quality≥1000Unit,please send inquire:
Online Service

Product Inquiry

Customer Reviews

Trade Alert - Delivering the latest product trends and industry news straight to your inbox.

Customer Services
About Us
Chemicalorigin
Trade Services
 ©2020 Dideu Industries Group Limited