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High Quality USP/EP/BP GMP DMF FDA Lacidipine Tablets CAS NO 103890-78-4 Producer

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Price: $ 0.08 / Tablet
Quantity:
min order: 1 Tablet
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ196
  • Dideu
  • 103890-78-4
  • C26H33NO6
  • 638-759-0
  • China
  • Lacidipine 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

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Lacidipine Tablets 

Action and use

Calcium channel blocker.

Definition

Lacidipine Tablets contain Lacidipine. They are coated. 

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

Content of lacidipine, C26H33NO6 

95.0 to 105.0% of the stated amount.

Carry out all of the following procedures protected from light and prepare solutions immediately before use. 

Identification

A.  Shake a quantity of whole tablets containing 4 mg of Lacidipine with 50 ml of absolute ethanol with the aid of ultrasound for 30 minutes. Dilute to 100 ml with absolute ethanol and filter through a 0.45-µm membrane filter (Millipore Millex is suitable). The light absorption of the filtrate, Appendix II B, in the range 250 to 400 nm exhibits maxima only at 284 nm and 368 nm.


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).

Tests

Related substances

Dissolution

Comply with 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 as the medium 500 ml of a solution prepared by mixing 100 ml of water with 10 ml of polysorbate 20 , shaking gently and diluting to 1000 ml with water at a temperature of 37°. 


procedure 

(1)  After 45 minutes, withdraw a sample of 10 ml of the medium and filter immediately through a 0.45-µm membrane filter (Millipore Millex is suitable), having first activated the filter with 3 ml of methanol followed by 5 ml of a 1% w/v solution of polysorbate 20 . Measure the absorbance of the filtrate in a 2-cm cell, suitably diluted with the dissolution medium if necessary, at the maximum at 284 nm, Appendix II B, using the dissolution medium in the reference cell. 


(2)  Measure the absorbance, in a 2 cm cell, of a solution of lacidipine BPCRS prepared by diluting a 0.02% w/v solution in absolute ethanol to a suitable volume with the dissolution medium at the maximum at 284 nm, Appendix II B, using the dissolution medium in the reference cell. 


determination of content

Calculate the total content of lacidipine, C26H33NO6, in the medium using the declared content of C26H33NO6 in lacidipine BPCRS .


Related substances

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


(1)  Shake a quantity of the powdered tablets containing 20 mg of Lacidipine with 50 ml of absolute ethanol with the aid of ultrasound for 15 minutes. Cool, dilute to 100 ml with absolute ethanol , filter through a 0.45-µm membrane filter (Millipore Millex is suitable) and dilute 5 volumes of the filtrate to 20 volumes with hexane . 

(2)  Dilute 1 volume of solution (1) to 100 volumes with the mobile phase. 

(3)  Dilute 1 volume of a 0.1% w/v solution of lacidipine impurity standard BPCRS in absolute ethanol to 5 volumes with the mobile phase.


chromatographic conditions

(a)  Use a stainless steel column (25  cm x 4.6  mm) packed with cyanosilyl silica gel for chromatography (5 µm) (Spherisorb CN is suitable). 

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

(c)  Use a flow rate of 2 ml per minute.

(d)  Use ambient column temperature. 

(e)  Use a detection wavelength of 240 nm.

(f)  Inject 20 µl of each solution.

(g)  If necessary adjust the composition of the mobile phase so that, in the chromatogram obtained with solution (3), the retention time of the peak due to lacidipine is about 10 minutes.

(h)  For solution (1) allow the chromatography to proceed for 2 times the retention time of the principal peak.


mobile phase 

3 volumes of absolute ethanol and 97 volumes of n- hexane. 


system suitability

The test is not valid unless the chromatogram obtained with solution (3) closely resembles the chromatogram supplied with lacidipine impurity standard BPCRS .


limits 

In the chromatogram obtained with solution (1):


the area of any peak due to lacidipine impurity B is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (2%, taking into account the correction factor of 2);


the area of any other secondary peak is not greater than half the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);


the total nominal content of impurities is not greater than 2.5%;


disregard any peak with a relative retention time of 1.5 with respect to the peak due to lacidipine impurity B.


Uniformity of content 

Tablets containing less than 2 mg or 2% of Lacidipine comply with the requirements stated under Tablets using the following method of analysis. Place one tablet in 50 ml of absolute ethanol , disperse the tablet completely with the aid of ultrasound for 30 minutes crushing with a glass rod if it does not disintegrate, and mix. Cool and filter through a 0.45-µm membrane filter (Millipore Millex is suitable). If necessary further dilute with absolute ethanol to produce a solution containing 0.004% w/v of Lacidipine. Measure the absorbance of the resulting solution at the maximum at 368 nm, Appendix II B, using absolute ethanol in the reference cell. Calculate the content of C26H33NO6 in each tablet from the absorbance obtained from a 0.004% w/v solution of lacidipine BPCRS in absolute ethanol and using the declared content of C26H33NO6 in lacidipine BPCRS. 

Assay

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

(1)  Disperse with the aid of ultrasound 10 whole tablets in 50 ml of absolute ethanol for 10 minutes, cool and filter through a 0.45-µm membrane filter (Millipore Millex is suitable). Dilute a quantity of the filtrate with sufficient mobile phase to produce a solution containing 0.01% w/v of Lacidipine. 

(2)  Dilute 5 volumes of a 0.04% w/v solution of lacidipine BPCRS in absolute ethanol to 20 volumes with the mobile phase.

(3)  Dilute 1 volume of a 0.1% w/v solution of lacidipine impurity standard BPCRS in absolute ethanol to 5 volumes with the mobile phase.


chromatographic conditions

The chromatographic conditions described under Related substances may be used.


system suitability

The test is not valid unless the chromatogram obtained with solution (3) closely resembles the chromatogram supplied with lacidipine impurity standard BPCRS .


determination of content

Calculate the content of C26H33NO6 in the tablets using the declared content of C26H33NO6 in lacidipine BPCRS .

Storage

Lacidipine Tablets should be protected from light.

Impurities

The impurities limited by the requirements of this monograph include those listed under Lacidipine.




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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