Online

Cart
You are here: Home » Products » Pharmaceutical Ingredient » Circulatory System » High Quality USP/EP/BP GMP DMF FDA Glyceryl Trinitrate Tablets CAS NO 55-63-0 Producer
Share to:

High Quality USP/EP/BP GMP DMF FDA Glyceryl Trinitrate Tablets CAS NO 55-63-0 Producer

5 0 Reviews
Price: $ 0.08 / Tablet
Quantity:
min order: 1 Tablet
View wholesale prices
  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ181
  • Dideu
  • 55-63-0
  • C3H5N3O9
  • 200-240-8
  • China
  • Glyceryl Trinitrate 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

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

Glyceryl Trinitrate Tablets

Definition

Glyceryl Trinitrate Tablets are sublingual tablets made with Mannitol as the basis and may be prepared by adding Glyceryl Trinitrate Solution of an appropriate concentration to dried granules of Mannitol, mixing intimately, drying at a temperature not exceeding 50° or without heating for not more than 4  hours and compressing.


CAUTION Undiluted glyceryl trinitrate can be exploded by percussion or excessive heat. Appropriate precautions should be exercised and only exceedingly small amounts should be isolated.


The tablets comply with the requirements stated under Oromucosal Preparations and with the following requirements.

Content of glyceryl trinitrate, C3H5N3O9 

85.0  to 115.0% of the stated amount.
Identification

A.  Carry out the method for thin-layer chromatography , Appendix III A, using silica gel G as the coating substance and toluene as the mobile phase. Apply separately to the plate 20 µl of each of the following solutions. For solution (1) extract a quantity of the powdered tablets containing 0.5  mg of glyceryl trinitrate with 1  ml of acetone and centrifuge. For solution (2) dilute a quantity of glyceryl trinitrate solution BPCRS with sufficient water to produce a solution containing 0.05% w/v of glyceryl trinitrate. After removal of the plate, dry it in a stream of air, spray with diphenylamine solution R1 and irradiate for 15  minutes with ultraviolet light (365  nm) . Examine the plate in daylight. The spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).


B.  Extract a quantity of the powdered tablets containing 3  mg of glyceryl trinitrate with 5  ml of ether and filter. Evaporate the ether and dissolve the residue in 0.2  ml of sulphuric acid containing a trace of diphenylamine . An intense blue colour is produced.

Tests

Related substances

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 2.5  mg of glyceryl trinitrate with 10  ml of acetonitrile with the aid of ultrasound, filter through a 4-µm filter and dilute one volume of the filtrate with an equal volume of water. For solution (2) dilute 1  volume of solution (1) to 100  volumes with the mobile phase. For solution (3) dilute a quantity of glyceryl trinitrate solution BPCRS with sufficient 1m hydrochloric acid to produce a solution containing 0.05% w/v of glyceryl trinitrate and heat in a reaction vial at 100° for 30  minutes.


The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm × 4.6  mm) packed with with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil ODS is suitable), (b) as the mobile phase with a flow rate of 1  ml per minute a mixture of 40  volumes of acetonitrile and 60  volumes of water and (c) a detection wavelength of 210  nm.


Inject 50 µl of each solution and, for solution (1), allow the chromatography to proceed for three times the retention time of the principal peak. The test is not valid unless the chromatogram obtained with solution (3) resembles the reference chromatogram supplied with glyceryl trinitrate solution BPCRS in that it shows a principal peak due to glyceryl trinitrate and two clearly separated peaks due to the dinitrate impurities with retention times relative to glyceryl trinitrate of approximately 0.5.


In the chromatogram obtained with solution (1) the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%) and the sum of the areas of any such peaks is not greater than three times the area of the principal peak in the chromatogram obtained with solution (2) (3%). Disregard any peak with an area less than 0.1  times the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).


Uniformity of content 

Tablets containing less than 2  mg of glyceryl trinitrate 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. For solution (1) add 2  ml of acetonitrile to one tablet, mix with the aid of ultrasound for 5  minutes, filter through a 4-µm filter and dilute 1  volume of the filtrate with an equal volume of water. For solution (2) dilute glyceryl trinitrate solution BPCRS with the mobile phase to produce a solution containing the equivalent amount of glyceryl trinitrate as that expected for solution (1). For solution (3) dilute a quantity of glyceryl trinitrate solution BPCRS with sufficient 1m hydrochloric acid to produce a solution containing 0.05% w/v of glyceryl trinitrate and heat in a reaction vial at 100° for 30  minutes.


The chromatographic conditions described under Related substances may be used.


Inject 50 µl of each solution. The test is not valid unless the chromatogram obtained with solution (3) resembles the reference chromatogram supplied with glyceryl trinitrate solution BPCRS in that it shows a principal peak due to glyceryl trinitrate and two clearly separated peaks due to the dinitrate impurities with retention times relative to glyceryl trinitrate of approximately 0.5.


Calculate the content of C3H5N3O9 in each tablet from the chromatograms obtained and using the declared content of C3H5N3O9 in glyceryl trinitrate solution BPCRS .

Assay

Use the average of the 10 individual results obtained from the test for Uniformity of content.

Storage

Glyceryl Trinitrate Tablets should be protected from light and stored in a glass container closed by means of a screw closure lined with aluminium or tin foil; additional packing that absorbs glyceryl trinitrate should be avoided. Glyceryl Trinitrate Tablets should be issued for patients in containers of not more than 100  tablets.

Labelling

The label states the amount of glyceryl trinitrate per tablet.




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

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