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High Quality USP/EP/BP GMP DMF FDA Loperamide Capsules CAS NO 53179-11-6 Producer

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Price: $ 0.08 / pcs
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min order: 1 pcs
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ436
  • Dideu
  • 53179-11-6
  • C29H33ClN2O2
  • 258-416-5
  • China
  • Loperamide 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

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Loperamide Capsules 

Action and use

Opioid receptor agonist; antidiarrhoeal.

Definition

Loperamide Capsules contain Loperamide Hydrochloride.


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

Content of loperamide hydrochloride, C29H33ClN2O2,HCl

95.0  to 105.0% of the stated amount.
Identification

A.  Carry out the method for thin-layer chromatography , Appendix III A, using a silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable) and a mixture of 2.5  volumes of acetate buffer pH 4.7, 17.5  volumes of methanol , 27  volumes of ethyl acetate and 53  volumes of dichloromethane as the mobile phase. Apply separately to the plate 10 µl of each of the following solutions. For solution (1) shake a quantity of the contents of the capsules containing 10  mg of Loperamide Hydrochloride with 10  ml of methanol for 5  minutes and filter. Solution (2) contains 0.10% w/v of loperamide hydrochloride BPCRS in methanol . After removal of the plate, allow it to dry in air and examine under ultraviolet light (254  nm) . Expose the plate to iodine vapour and examine again. By each method of visualisation the principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).


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

Tests

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 500  ml of a buffer solution prepared by mixing 20  ml of 1m acetic acid with 60  ml of water, adjusting the pH to 4.7 with 1m sodium hydroxide and diluting to 100  ml with water, and rotate the paddle at 50 revolutions per minute. Withdraw a sample of 10  ml of the medium and filter. Carry out the method for liquid chromatography , Appendix III D, using the following solutions. Use the filtered dissolution medium as solution (1). Solution (2) contains 0.00040% w/v of loperamide hydrochloride BPCRS in the dissolution medium.


The chromatographic procedure described under Assay may be used.


Calculate the total content of loperamide hydrochloride, C29H33ClN2O2,HCl, in the medium using the declared content of C29H33ClN2O2,HCl in loperamide hydrochloride BPCRS .


Loperamide N-oxide

Carry out the method for thin-layer chromatography , Appendix III A, using a plate precoated with silica gel the surface of which has been modified with chemically-bonded octadecylsilyl groups (Whatman KC 18 plates are suitable) and a mixture of 30  volumes of water, adjusted to pH 3.0 by the addition of orthophosphoric acid , and 70  volumes of methanol as the mobile phase. Apply separately to the plate 25 µl of each of the following solutions. For solution (1) shake a quantity of the contents of the capsules containing 20  mg of Loperamide Hydrochloride with 40  ml of methanol for 15  minutes, filter and evaporate the filtrate to dryness using a rotary evaporator and a water bath at 30°; to the residue add 2  ml of methanol , mix with the aid of ultrasound, centrifuge and use the supernatant liquid. Solution (2) contains 0.010% w/v of loperamide N-oxide BPCRS in methanol . After removal of the plate, allow it to dry in air and expose to iodine vapour for 16  hours. In the chromatogram obtained with solution (1) any spot corresponding to loperamide N-oxide is not more intense than the principal spot in the chromatogram obtained with solution (2) (1%).


Uniformity of content 

Capsules containing 2  mg of Loperamide Hydrochloride or less comply with the requirements stated under Capsules using the following method of analysis. Carry out the method for liquid chromatography , Appendix III D, using the following solutions. For solution (1) add 150  ml of water to one whole capsule and mix with the aid of ultrasound for 30  minutes, shake mechanically for 30  minutes and dilute to 200  ml with acetonitrile , filter and use the filtrate. For solution (2) dissolve 10  mg of loperamide hydrochloride BPCRS in 45  ml of water and dilute to 100  ml with acetonitrile . Dilute 1  volume of the resulting solution to 10  volumes with the same solvent mixture.


The chromatographic procedure described under Assay may be used.


Calculate the content of C29H33ClN2O2,HCl in each capsule using the declared content of C29H33ClN2O2,HCl in loperamide hydrochloride BPCRS .

Assay

Prepare 0.005m sodium octanesulphonate containing, per 1000  ml, 1  ml of 13.5m ammonia and 0.5  ml of triethylamine and adjust the pH to 3.2 with orthophosphoric acid (solvent A). Carry out the method for liquid chromatography Appendix III D, using the following solutions. For solution (1) mix a quantity of the mixed contents of 20 capsules containing 20  mg of Loperamide Hydrochloride with 90  ml of water with the aid of ultrasound for 10  minutes, shake for 30  minutes, dilute to 200  ml with acetonitrile and filter. Solution (2) contains 0.010% w/v of loperamide hydrochloride BPCRS in a mixture of 45  volumes of water and 55  volumes of acetonitrile. 


The chromatographic procedure may be carried out using (a) a stainless steel column (15  cm × 4  mm) packed with end-capped octadecylsilyl silica gel for chromatography (4 µm) (Novapak C18 is suitable), (b) as the mobile phase with a flow rate of 1.5  ml per minute a mixture of 45  volumes of solvent A and 55  volumes of acetonitrile and (c) a detection wavelength of 226  nm.


Calculate the content of C29H33ClN2O2,HCl in the capsules using the declared content of C29H33ClN2O2,HCl in loperamide hydrochloride BPCRS .

Impurities

1103-1618

A.  Loperamide N-oxide




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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