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High Quality USP/EP/BP GMP DMF FDA Prednisolone Tablets CAS NO 50-24-8 Producer

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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
  • AZ293
  • Dideu
  • 50-24-8
  • C21H28O5
  • 200-021-7
  • China
  • Prednisolone 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:

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Prednisolone Tablets 

Action and use

Glucocorticoid.

Definition

Prednisolone Tablets contain Prednisolone.

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

Content of prednisolone, C21H28O5

90.0  to 110.0% of the stated amount.
Identification

Extract a quantity of the powdered tablets with acetone, filter and evaporate the filtrate to dryness. The residue complies with the following tests.


A.  The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of prednisolone (RS 282).


B.  Complies with the test for the Identification of steroids, Appendix III A, using impregnating solvent I and mobile phase A.

Tests

Related substances

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using Apparatus 2. Use as the medium 900  ml of water and rotate the paddle at 50 revolutions per minute.


Carry out the method for liquid chromatography, Appendix III D, injecting 0.2  ml of each of the following solutions. For solution (1) prepare a 0.1% w/v solution of prednisolone BPCRS in methanol and dilute with water to contain 0.0001% w/v. For solution (2) use the dissolution medium diluted, if necessary, with water to contain 0.0001% w/v of prednisolone.


The chromatographic procedure described under Uniformity of content may be used.


The test is not valid unless the column efficiency, determined using the peak due to prednisolone in the chromatogram obtained with solution (1), is greater than 15,000 theoretical plates per metre.


Calculate the total content of C21H28O5 in the medium using the declared content of C21H28O5 in prednisolone BPCRS.


Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) shake a quantity of the powdered tablets containing 10  mg of Prednisolone with 25  ml of methanol for 10  minutes and mix with the aid of ultrasound for 2  minutes; filter the extract (Whatman GF/F is suitable), wash the filter with two 10 ml quantities of methanol, combine the filtrate and washings and evaporate to dryness using a rotary evaporator and a warm water bath; dissolve the residue in 10  ml of tetrahydrofuran and dilute to 20  ml with water. Solution (2) contains 0.002% w/v each of prednisolone BPCRS and hydrocortisone BPCRS in the mobile phase. For solution (3) dilute 1  volume of solution (1) to 100  volumes with a 50% v/v solution of tetrahydrofuran.


The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Alltima C18 is suitable) and maintained at 45°, (b) as mobile phase at a flow rate of 1  ml per minute a mixture prepared as follows: mix 220  volumes of tetrahydrofuran with 700  volumes of water, allow to equilibrate, dilute to 1000  volumes with water and mix and (c) a detection wavelength of 254  nm.


Equilibrate the column with the mobile phase at a flow rate of 1  ml per minute for about 30  minutes. Adjust the sensitivity so that the height of the principal peak in the chromatogram obtained with solution (3) is at least 50% of the full scale of the recorder.


Inject 20 µl of solution (2). When the chromatograms are recorded in the prescribed conditions, the retention times are: prednisolone about 14  minutes and hydrocortisone about 15.5  minutes. The test is not valid unless, in the chromatogram obtained with solution (2), the resolution factor between the peaks due to prednisolone and hydrocortisone is at least 2.2. If necessary, adjust the concentration of tetrahydrofuran in the mobile phase.


Inject separately 20 µl of the solvent mixture of solution (1) as a blank, 20 µl of solution (1) and of solution (3). Continue the chromatography for 4.5  times the retention time of the principal peak.


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 (3) (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 (3) (3%). Disregard any peak with an area less than 0.05  times the area of the principal peak in the chromatogram obtained with solution (3) (0.05%) and any peak with a retention time of 3  minutes or less.


Uniformity of content

Tablets containing less than 2  mg of Prednisolone 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. Solution (1) contains 0.0050% w/v of prednisolone BPCRS and 0.0075% w/v of dexamethasone (internal standard) in the mobile phase. For solution (2) add 20  ml of the mobile phase to one tablet, mix with the aid of ultrasound for at least 10  minutes, mix thoroughly, centrifuge and use the supernatant liquid. Prepare solution (3) in the same manner as solution (2) but using a 0.0075% w/v solution of the internal standard in the mobile phase in place of the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (20  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable), (b) a mixture of 58  volumes of methanol and 42  volumes of water as the mobile phase with a flow rate of 1.5  ml per minute and (c) a detection wavelength of 254  nm.


The test is not valid unless the resolution factor between the peaks due to prednisolone and dexamethasone is greater than 2.5 and the column efficiency, determined using the peak due to prednisolone in the chromatogram obtained with solution (1), is greater than 15,000 theoretical plates per metre.


Calculate the content of C21H28O5 using the declared content of C21H28O5 in prednisolone BPCRS.

Assay

Weigh and powder 20  tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.005% w/v of prednisolone BPCRS and 0.0075% w/v of dexamethasone (internal standard) in a mixture of 58  volumes of methanol and 42  volumes of water. For solution (2) add 58  ml of methanol to a quantity of the powder containing 5  mg of Prednisolone, shake for 10  minutes, add sufficient water to produce 100  ml, mix and filter. Prepare solution (3) in the same manner as solution (2) but add 10  ml of a 0.075% w/v solution of dexamethasone in methanol and 48  ml of methanol in place of the 58  ml of methanol.


The chromatographic procedure may be carried out using (a) a stainless steel column (20  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable), (b) a mixture of 42  volumes of water and 58  volumes of methanol as the mobile phase with a flow rate of about 1  ml per minute and (c) a detection wavelength of 254  nm.


The assay is not valid unless the resolution factor between the peaks due to prednisolone and dexamethasone is greater than 2.5 and the column efficiency, determined using the peak due to prednisolone in the chromatogram obtained with solution (1), is greater than 15,000 theoretical plates per metre.


Calculate the content of C21H28O5 in the tablets using the declared content of C21H28O5 in prednisolone BPCRS.

Storage

Prednisolone 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

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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