Online

Cart
You are here: Home » Products » Pharmaceutical Ingredient » Antibiotics » High Quality USP/EP/BP GMP DMF FDA Minocycline Tablets CAS NO 10118-90-8 Producer
Share to:

High Quality USP/EP/BP GMP DMF FDA Minocycline Tablets CAS NO 10118-90-8 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
  • AZ234
  • Dideu
  • 10118-90-8
  • C23H27N3O7
  • 800-277-5
  • China
  • Minocycline 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

Minocycline Tablets 

Action and use

Tetracycline antibacterial.

Definition

Minocycline Tablets contain Minocycline Hydrochloride Dihydrate.

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

Content of minocycline, C23H27N3O7

92.5  to 107.5% of the stated amount.

Identification

A.  Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions. 


(1)  Extract a quantity of the powdered tablets containing the equivalent of 10  mg of minocycline with 20  ml of methanol, centrifuge and use the supernatant liquid. 

(2)  0.05% w/v of minocycline hydrochloride BPCRS in methanol. 

(3)  0.05% w/v of each of minocycline hydrochloride BPCRS and doxycycline hyclate BPCRS in methanol. 


chromatographic conditions

(a)  Use silica gel GF254 as the coating substance. Adjust the pH of a 10.0% w/v solution of disodium edetate to 9.0 with 10m sodium hydroxide and spray the solution evenly onto the plate (about 10  ml for a plate 100  mm × 200  mm). Allow the plate to dry in a horizontal position for at least 1  hour. Dry the plate at 110° for 1  hour immediately before use.

(b)  Use the mobile phase described below.

(c)  Apply 2 µl of each solution.

(d)  Develop the plate to 15 cm.

(e)  After removal of the plate, dry it in a current of air and examine under ultraviolet light (254  nm). 


mobile phase

A mixture of 6  volumes of water, 35  volumes of methanol and 59  volumes of dichloromethane.


system suitability

The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated principal spots.


confirmation

The principal spot in the chromatogram obtained with solution (1) is similar in position and size to that in the chromatogram obtained with solution (2). 


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


C.  Shake a quantity of the powdered tablets containing the equivalent of 50  mg of minocycline with 5  ml of water and filter. The filtrate yields reaction A characteristic of chlorides, Appendix VI.

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.


test conditions

(a)  Use Apparatus 2, rotating the paddle at 50 revolutions per minute.

(b)  Use 900 ml of 0.1m hydrochloric acid, at a temperature of 37° ± 0.5°, as the medium.


procedure 

(1)  After 45 minutes withdraw a sample of 10  ml of the medium and filter, discarding the first few ml of filtrate. Dilute the filtered solution, if necessary, with 0.1m hydrochloric acid to give a solution expected to contain the equivalent of about 0.001% w/v of minocycline. Measure the absorbance of the solution at the maximum at 348  nm, Appendix II B, using 0.1m hydrochloric acid in the reference cell.


(2)  Measure the absorbance of a 0.001% w/v solution of minocycline hydrochloride BPCRS in 0.1m hydrochloric acid using 0.1m hydrochloric acid in the reference cell.


determination of content 

Calculate the total content of minocycline, C23H27N3O7, in the medium from the absorbances obtained and using the declared content of C23H27N3O7,HCl in minocycline hydrochloride BPCRS. Each mg of C23H27N3O7,HCl is equivalent to 0.9261 mg of C23H27N3O7.


Related substances

Carry out the method for liquid chromatography, Appendix III D, protected from light. Store the solutions at a temperature of 2° to 8° and use within 3  hours of preparation. 


(1)  Shake a quantity of the powdered tablets containing the equivalent of 25  mg of minocycline with 50  ml of water, dilute to 100  ml with the same solvent and filter. 

(2)  Dilute 1  volume of solution (1) to 50  volumes with water. 

(3)  Dilute 1.2  volumes of solution (1) to 100  volumes with water. 

(4)  Dissolve 10  mg of minocycline hydrochloride BPCRS in water and evaporate to dryness on a water bath. Dissolve the residue in 10  ml of mobile phase and add sufficient mobile phase to produce 25  ml.


chromatographic conditions

(a)  Use a stainless steel column (20 cm × 4.6 mm) packed with end-capped octylsilyl silica gel for chromatography (5 µm) (Nucleosil C8 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 280  nm.

(f)  Inject 20 µl of each solution.

(g)  For solution (1) allow the chromatography to proceed for 1.5 times the retention time of minocycline.


mobile phase

A mixture of 25  volumes of a 0.4%  w/v solution of sodium edetate, 27  volumes of dimethylformamide and 50 volumes of a 2.8%  w/v solution of ammonium oxalate, adjusted to pH 7.0 using a 10.4%  w/v solution of tetrabutylammonium hydroxide.


When the chromatograms are recorded using the prescribed conditions the retention time of minocycline is about 15  minutes. 


system suitability

The chromatogram obtained with solution (4) shows a peak with a retention time relative to minocycline of about 0.8 [4-epiminocycline (Ph.Eur. impurity A)].


The test is not valid unless, in the chromatogram obtained with solution (4), the resolution factor between the peaks due to minocycline and 4-epiminocycline is at least 2.0.


limits

In the chromatogram obtained with solution (1):


the area of any peak due to 4-epiminocycline is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (2%);


the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (1.2%); 


the sum of the areas of any such peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (2%). 


Disregard any peak with an area less than 0.05 times the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).

Assay

Weigh and powder 20  tablets. Carry out the method for liquid chromatography, Appendix III D, protected from light. Store the solutions at a temperature of 2° to 8° and use within 3  hours of preparation. 


(1)  Shake a quantity of the powdered tablets containing the equivalent of 25  mg of minocycline with 50  ml of water, dilute to 100  ml with the same solvent, filter and dilute 10  ml of the filtrate to 20  ml with water.

(2)  0.0125% w/v of minocycline hydrochloride BPCRS in water. 

(3)  Dissolve 10  mg of minocycline hydrochloride BPCRS in water and evaporate to dryness on a water bath. Dissolve the residue in 10  ml of mobile phase and add sufficient mobile phase to produce 25  ml.


chromatographic conditions

The chromatographic conditions described under Related substances may be used.


When the chromatograms are recorded using the prescribed conditions the retention time of minocycline is about 15  minutes. 


system suitability

The chromatogram obtained with solution (3) shows a peak with a retention time relative to minocycline of about 0.8 [4-epiminocycline (Ph.Eur. impurity A)].


The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to minocycline and 4-epiminocycline is at least 2.0.


determination of content

Calculate the content of C23H27N3O7 in the tablets from the chromatograms obtained and using the declared content of C23H27N3O7,HCl in minocycline hydrochloride BPCRS. Each mg of C23H27N3O7,HCl is equivalent to 0.9261 mg of C23H27N3O7.

Labelling

The quantity of active ingredient is stated in terms of the equivalent amount of minocycline.




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