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High Quality USP/EP/BP GMP DMF FDA Lomustine Capsules CAS NO 13010-47-4 Producer

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  • AZ435
  • Dideu
  • 13010-47-4
  • C9H16ClN3O2
  • 235-859-2
  • China
  • Lomustine 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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Lomustine Capsules 

Action and useCytotoxic alkylating agent.

Definition

Lomustine Capsules contain Lomustine.


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

Content of lomustine, C9H16ClN3O2 

90.0  to 110.0% of the stated amount.
Identification

Carry out the following procedure in subdued light. Shake a quantity of the contents of the capsules containing 0.2  g of Lomustine with 10  ml of methanol , filter and evaporate the filtrate to dryness using a rotary evaporator on a water bath maintained at not more than 60°. The residue, after drying at 60° at a pressure not exceeding 0.7  kPa for 30  minutes, complies with the following tests.


A.  The infrared absorption spectrum , Appendix II A, is concordant with the reference spectrum of lomustine (RS 204) .


B.   Melting point , about 88°, Appendix V A.

Tests

Related substances

A.  Examine by thin-layer chromatography , Appendix III A, using silica gel G as the coating substance and a mixture of 20  volumes of glacial acetic acid and 80  volumes of toluene as the mobile phase. Apply separately to the plate 5 µl of each of the following solutions. For solution (1) shake a quantity of the contents of the capsules containing 0.20  g of Lomustine with 10  ml of methanol and filter. For solution (2) dilute 1  volume of solution (1) to 25  volumes with methanol . For solution (3) dilute 1  volume of solution (2) with 1  volume of methanol . For solution (4) dilute 1  volume of solution (2) to 10  volumes with methanol . For solution (5) dilute 1  volume of solution (2) to 20  volumes with methanol . For solution (6) dissolve 10  mg of lomustine EPCRS and 10  mg of 1,3-dicyclohexylurea in methanol and dilute to 10  ml with the same solvent. After removal of the plate, dry it at 110° for 1  hour. At the bottom of a chromatography tank, place an evaporating dish containing a mixture of 1  volume of 7m hydrochloric acid , 1  volume of water and 2  volumes of a 1.5% w/v solution of potassium permanganate , close the tank and allow to stand for 15  minutes. Place the dried plate in the tank and close the tank. Leave the plate in contact with the chlorine vapour for 5  minutes. Withdraw the plate and place it in a current of cold air until the excess of chlorine is removed and an area of coating below the line of application does not give a blue colour with a drop of potassium iodide and starch solution . Spray with potassium iodide and starch solution . Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (4) (0.4%) and at most one such spot is more intense than the spot in the chromatogram obtained with solution (5) (0.2%). The test is not valid unless the chromatogram obtained with solution (6) shows two clearly separated principal spots.


B.  Examine by liquid chromatography , Appendix III D. For solution (1) shake a quantity of the contents of the capsules containing 0.20  g of Lomustine with 10  ml of methanol and filter. For solution (2) dilute 2  volumes of solution (2) to 100  volumes with methanol .


The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm × 4  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5  to 10 µm) (Nucleosil C18 is suitable), (b) as mobile phase with a flow rate of 2  ml per minute a mixture of 50  volumes of methanol and 50  volumes of water, (c) a detection wavelength of 230  nm and (d) a loop injector.


Inject 20 µl of solution (1). When the chromatograms are recorded in the prescribed conditions, the retention time of lomustine is about 25  minutes. When using a recorder, adjust the sensitivity of the system so that the height of the principal peak in the chromatogram obtained with solution (1) is not less than 50% of the full scale of the recorder.


Inject separately 20 µl of each solution. In the chromatogram obtained with solution (1) the sum of the areas of any secondary 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 that of the principal peak in the chromatogram obtained with solution (2) (0.1%).

Assay

Carry out the following procedure in subdued light. Shake a quantity of the mixed contents of 20 capsules containing 40  mg of Lomustine with 70  ml of ethanol (96%) for 20  minutes, dilute to 100  ml with the same solvent and filter. Dilute 5  ml of the filtrate to 100  ml with ethanol (96%) and measure the absorbance of the resulting solution at the maximum at 230  nm, Appendix II B. Calculate the content of C9H16ClN3O2  taking 260 as the value of A(1%, 1  cm) at the maximum at 230  nm.




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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