Our Reference Specification, for more details, pls contact us for COA,MSDS and certification:
Email & Skype: firstname.lastname@example.org Telephone:+86-29-89586682
Mobile:+86-15129568250; Whatsapp: +8615129568250
|Action and use|| |
HMG Co-A reductase inhibitor; lipid-regulating drug.
Simvastatin Tablets contain Simvastatin.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of simvastatin, C25H38O5
|90.0 to 110.0% of the stated amount.|
|Identification || |
Shake a quantity of the powdered tablets containing 50 mg of Simvastatin with 20 ml of dichloromethane, filter through glass fibre filter paper (Whatman GF/C is suitable) and evaporate the filtrate to dryness using a rotary evaporator and a water bath at 40°. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of simvastatin (RS 423).
Carry out the dissolution test for tablets and capsules, Appendix XII B1, using Apparatus 2. Use as the medium 900 ml of 0.01m sodium dihydrogen orthophosphate containing 0.5% w/v of sodium dodecyl sulphate and adjusted to pH 7.0 with 1m sodium hydroxide and rotate the paddle at 50 revolutions per minute. After 30 minutes, withdraw a sample of 20 ml of the medium, filter and transfer 10 ml of the filtrate into a centrifuge tube containing 0.1 g of pre-washed manganese(iv) oxide. Shake the tube for 30 minutes, or until the manganese(iv) oxide is completely dispersed, centrifuge and measure the absorbance of the clear supernatant liquid, suitably diluted with dissolution medium if necessary, at the maximum at 247 nm and at the minimum at 257 nm, Appendix II B, using dissolution medium that has been similarly treated with pre-washed manganese(iv) oxide in the reference cell. At the same time measure the absorbance of a suitable solution of simvastatin BPCRS, prepared by dissolving simvastatin BPCRS in the dissolution medium and treating with pre-washed manganese(iv) oxide as described above, at 247 nm and at 257 nm.
Calculate the total content of simvastatin, C25H38O5, in the medium using the differences in absorbance at 247 nm and at 257 nm and using the declared content of C25H38O5 in simvastatin BPCRS.
Mix 1 volume of a 0.3% v/v solution of glacial acetic acid adjusted to pH 4.0 with 1m sodium hydroxide with 4 volumes of acetonitrile (solution A).
Prepare a 0.51% w/v solution of sodium dihydrogen orthophosphate adjusted to pH 4.5 with a 25% v/v solution of orthophosphoric acid (pH 4.5 buffer solution).
Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared immediately before use.
(1) Mix with the aid of ultrasound a quantity of the powdered tablets containing 25 mg of Simvastatin with 20 ml of solution A for 10 minutes, shake for 15 minutes, cool and add sufficient solution A to produce 100 ml, filter through a 0.45 µm membrane filter.
(2) Dilute 1 volume of solution (1) to 500 volumes with solution A.
(3) 0.002% w/v simvastatin BPCRS and 0.002% w/v lovastatin EPCRS in solution A.
(a) Stainless steel column (10 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (3 µm) (Hypersil ODS is suitable).
(b) Gradient elution using the mobile phase described below.
(c) Flow rate of 1.5 ml per minute.
(d) Column temperature of 30°.
(e) Detection wavelength of 238 nm.
(f) Injection volume of 20 µl for each solution.
Mobile phase A Mix 40 volumes of acetonitrile with 60 volumes of pH 4.5 buffer solution.
Mobile phase B Mix 20 volumes of pH 4.5 buffer solution with 80 volumes of acetonitrile.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to simvastatin and lovastatin is at least 3.0
When the chromatograms are recorded under the prescribed conditions the retention times with respect to simvastatin are: simvastatin hydroxy acid about 0.52, lovastatin about 0.71, epilovastatin about 0.74, anhydrosimvastatin about 1.74 and simvastatin dimer about 2.42.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to lovastatin and epilovastatin is not greater than five times the area of the principal peak in the chromatogram obtained with solution (2) (1.0%);
the area of any other secondary peak excluding any peaks corresponding to lovastatin and epilovastatin is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (0.4%);
the sum of the areas of all the secondary peaks excluding any peaks corresponding to lovastatin and epilovastatin is not greater than five times the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).
Disregard any peak with an area less than a quarter of the area of the principal peak in the chromatogram obtained with solution (2) (0.05%).
|Assay || |
Add 3 ml of glacial acetic acid to 900 ml of water, adjust the pH to 4.0 with 1m sodium hydroxide and add sufficient water to produce 1000 ml. Mix 1 volume of this solution with 4 volumes of acetonitrile (solution A).
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Mix a quantity of whole tablets containing 0.16 g of Simvastatin in water and mix with the aid of ultrasound and shaking until completely dispersed. Add sufficient of solution A to produce about 75 ml, mix with the aid of ultrasound and shaking for 15 minutes, allow to cool to room temperature, add sufficient of solution A to produce 100 ml and centrifuge. Dilute a volume of the clear supernatant solution with sufficient of solution A to produce a solution containing 0.01% w/v of Simvastatin
(2) 0.01% w/v of simvastatin BPCRS in solution A.
(a) Stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS is suitable).
(b) Isocratic elution using the mobile phase described below.
(c) Flow rate of 1.5 ml per minute.
(d) Column temperature of 45°.
(e) Detection wavelength of 238 nm.
(f) Injection volume of 20 µl for each solution.
A mixture of 7 volumes of a buffer solution prepared as described below and 13 volumes of acetonitrile. To prepare the buffer solution dissolve 5.1 g of sodium dihydrogen orthophosphate in 900 ml of water, adjust the pH to 4.5 with either orthophosphoric acid or 1m sodium hydroxide and add sufficient water to produce 1000 ml.
The test is not valid unless the symmetry factor of the principal peak in the chromatogram obtained with solution (2) is less than 2.0.
Determination of content
Calculate the content of C25H38O5 in the tablets using the declared content of C25H38O5 in simvastatin BPCRS.
The impurities limited by the requirements of this monograph include those listed in the monograph for Simvastatin.
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.
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:
II)Nutrition Additive Industries
III)Daily-Use Chemical Products Industries & Agrochemicals
IV)Environmental Friendly Chemical And Chemurgy 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.