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High Quality USP/EP/BP GMP DMF FDA Ampicillin Capsules CAS NO 7177-48-2 Producer

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Price: $ 0.08 / pcs
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  • AZ384
  • Dideu
  • 7177-48-2
  • C16H25N3O7S
  • 615-347-9
  • China
  • Ampicillin Capsules
  • High quality
  • 99.0% Min
  • 99%-101%
  • Capsule
  • 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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Mobile:+86-15129568250; Whatsapp: +8615129568250

Ampicillin Capsules 

Action and use

Penicillin antibacterial.

Definition

Ampicillin Capsules contain Ampicillin or Ampicillin Trihydrate.

The capsules comply with the requirements stated under Capsules and with the following requirements.

Content of ampicillin, C16H19N3O4S

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)  Shake a quantity of the capsule contents containing the equivalent of 0.125  g of ampicillin with sufficient sodium hydrogen carbonate solution to produce 50  ml and filter.

(2)  0.25% w/v of ampicillin trihydrate BPCRS in sodium hydrogen carbonate solution.

(3)  0.25% w/v of each of ampicillin trihydrate BPCRS and amoxicillin trihydrate BPCRS in sodium hydrogen carbonate solution.


chromatographic conditions

(a)  Use a TLC silica gel silanised plate (Merck silanised silica gel 60 F254s (RP-18) plates are suitable).

(b)  Use the mobile phase described below. 

(c)  Apply 1 µl of each solution.

(d)  Develop the plate to 15 cm.

(e)  After removal of the plate, allow it to dry in air, expose it to iodine vapour until spots appear and examine in daylight.


mobile phase

10  volumes of acetone and 90  volumes of a 15.4% w/v solution of ammonium acetate adjusted to pH 5.0 with glacial acetic acid.


system suitability 

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


confirmation

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


B.  Suspend a quantity of the capsule contents containing the equivalent of 10  mg of ampicillin in 1  ml of water and add 2  ml of a mixture of 2  ml of cupri-tartaric solution R1 and 6  ml of water. A magenta-violet colour is produced immediately.

Tests

Related substances

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


(1)  Shake a quantity of the mixed capsule contents containing the equivalent of 0.3 g of ampicillin with 80 ml of mobile phase A with the aid of ultrasound for 15 minutes, add sufficient mobile phase A to produce 100 ml and filter through a 0.4-µm filter.

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

(3)  0.025% w/v of anhydrous ampicillin BPCRS and 0.002% w/v of cefradine BPCRS in mobile phase A.


chromatographic conditions 

(a)  Use a stainless steel column (25  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 is suitable).

(b)  Use gradient elution and the mobile phase described below. Equilibrate the column with a mobile phase ratio A:B of 85:15 and use this for the system suitability solution (3). Inject solutions (1) and (2) and start the elution isocratically with the chosen mobile phase. Immediately after elution of the ampicillin peak start the linear gradient elution. 

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

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 254 nm.

(f)  Inject 50 µl of each solution.


mobile phase 

Mobile phase A  Dilute a mixture of 1 volume of dilute acetic acid, 100 volumes of 0.2m potassium dihydrogen orthophosphate and 100 volumes of acetonitrile to 2000 volumes with water.


Mobile phase B  Dilute a mixture of 1 volume of dilute acetic acid, 100 volumes of 0.2m potassium dihydrogen orthophosphate and 800 volumes of acetonitrile to 2000 volumes with water.


1103-0948

Inject mobile phase A and use the same elution gradient to obtain a blank.


system suitability 

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to ampicillin and cefradine is at least 3.0. If necessary, adjust the composition of the mobile phase.


limits 

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%).

Assay

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


(1)  Shake a quantity of the mixed contents of 20 capsules containing the equivalent of 60  mg of ampicillin with 80  ml of solution A for 15  minutes, dilute to 100  ml with the same solvent, filter and dilute 5  ml of the solution to 50  ml with solution A.

(2)  0.006% w/v of anhydrous ampicillin BPCRS in solution A.

(3)  0.025% w/v of anhydrous ampicillin BPCRS and 0.002% w/v of cefradine BPCRS in solution A.


chromatographic conditions 

(a)  Use a stainless steel column (25  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 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 254 nm.

(f)  Inject 50 µl of each solution.


mobile phase 

15 volumes of solution B and 85 volumes of solution A.


Solution A  Dilute a mixture of 1  volume of dilute acetic acid, 100  volumes of 0.2m potassium dihydrogen orthophosphate and 100  volumes of acetonitrile to 2000  volumes with water.


Solution B  Dilute a mixture of 1  volume of dilute acetic acid, 100  volumes of 0.2m potassium dihydrogen orthophosphate and 800  volumes of acetonitrile to 2000  volumes with water.


system suitability 

The assay is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to ampicillin and cefradine is at least 3.0. If necessary, adjust the composition of the mobile phase to achieve the required resolution.


determination of content 

Calculate the content of C16H19N3O4S in the capsules using the declared content of C16H19N3O4S in anhydrous ampicillin BPCRS.

Labelling

When the active ingredient is Ampicillin Trihydrate, the quantity is stated in terms of the equivalent amount of ampicillin.




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.

Capsules 1CapsulesCapsules 106

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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