ildenafil citrate
Model Number: c001
Product Origin: China
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Other Price Terms: USDFOB
Payment Terms: CASH
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Product Origin: China
Brand Name:
Other Price Terms: USDFOB
Payment Terms: CASH
Supply Ability:
Minimum Order:
Delivery Lead Time:
Quality/Safety Certifications:
Sildenafil citrate is 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-
methylpiperazine citrate. It contains no le than 99.0% of C22H30N6O4S-C6H8O7, calculated on the dried basis.
Sildenafil citrate Is Medicine treatment raw material
Use: indicated for the treatment of erectile dysfunction.
Appearance: White Powder
Identification: Conforms
Mp(Melting Point): 186 ℃-187℃
Aay: 99.92%
Heavy Metals: <10PPM
Water Content: 0.51%
Residue on Ignition: 0.05%
Description A white or almost white crystalline powder; odorle; tastele. Slightly soluble in water, methanol. very slightly soluble in ethanol. insoluble in chloroform.
Melting point: 185-189℃, with decomposition. (AppendixⅡVIC,C.P.95)
Identification (1) The light absorption of a solution of 28μg per ml in acid chloride solution(0.1mol/L) exhibits maximum at 291nm and a minimum at 266nm. (AppendixⅡIVA,C.P.95) (2)The infra-red absorption spectrum (AppendixⅡVIC,C.P.95) is concordant with the reference spectrum of Sildenafil Citrate.
Related Substance Carry out the method for High Performance Liquid Chromatography. (AppendixⅡVIC,C.P.95)
The conditions and the suitability of the system: The chromatographic procedure may be carried out using a column packed with the octadecylsilane bonded silica gel. as stationary phase, a mixture of 50 volumes of 0.05mol/L triethylamine (adjusted to pH3.5 with phosphoric acid), 34 volumes of methanol and 16 volumes of acetonitrile as the mobile phase with a flow rate of 1.0ml per minute and a detection wavelength of 291nm. The number of theoretical plates of the column must no le than 2000, calculated on sildenafil Citrate.
Aay: Diolve the substance being examined with methanol and dilute it to 1.5mg/ml with the same solvent (Solution A). Diolve the reference substance with methanol and dilute it to 15μg/ml with the same solvent(Solution B). Inject 20μl of Solution B and adjust the sensitivity of the detector so that the high of principal peak in chromatogram obtained with solution B is 20% to 25% of full-scale deflection on the chart paper, then inject 20μl of Solution A and record the chromatograms for 2 times the retention time of principal peak. The sum of peck areas due to impurities is no greater than 1% of the total peak areas, if there are any secondary peaks in the chromatograms obtained with Solution A.
Lo on drying When dried to constant weight at 105℃,loses not more than 2.5% of its weight(AppendixⅡVIIIL,C.P.95).
Residue on ignition Using 1g, in a platinum crucible, not more than 0.1% (AppendixⅡVIIIN,C.P.95).
Heavy metals Carry out the limit test for heavy metal(AppendixⅡVIIIH,C.P.95), using the residue obtained in Residue on ignition; not more than 20ppm.
Aay Diolve about 0.25g, weigh accurately, in 30ml of glacial acetic acid and 10ml acetic anhydride, and add 1 drop of crystal violet IS. Titrate with perchloric acid(0.1mol/L) VS until the solution becomes yellowish-green, and the color changes to yellow after 30s. Perform a blank determination and make any neceary correction. Each ml of perchloric acid(0.1mol/L) VS is equivalent to 33.34mg of C22H30N6O4S-C6H8O7.
methylpiperazine citrate. It contains no le than 99.0% of C22H30N6O4S-C6H8O7, calculated on the dried basis.
Sildenafil citrate Is Medicine treatment raw material
Use: indicated for the treatment of erectile dysfunction.
Appearance: White Powder
Identification: Conforms
Mp(Melting Point): 186 ℃-187℃
Aay: 99.92%
Heavy Metals: <10PPM
Water Content: 0.51%
Residue on Ignition: 0.05%
Description A white or almost white crystalline powder; odorle; tastele. Slightly soluble in water, methanol. very slightly soluble in ethanol. insoluble in chloroform.
Melting point: 185-189℃, with decomposition. (AppendixⅡVIC,C.P.95)
Identification (1) The light absorption of a solution of 28μg per ml in acid chloride solution(0.1mol/L) exhibits maximum at 291nm and a minimum at 266nm. (AppendixⅡIVA,C.P.95) (2)The infra-red absorption spectrum (AppendixⅡVIC,C.P.95) is concordant with the reference spectrum of Sildenafil Citrate.
Related Substance Carry out the method for High Performance Liquid Chromatography. (AppendixⅡVIC,C.P.95)
The conditions and the suitability of the system: The chromatographic procedure may be carried out using a column packed with the octadecylsilane bonded silica gel. as stationary phase, a mixture of 50 volumes of 0.05mol/L triethylamine (adjusted to pH3.5 with phosphoric acid), 34 volumes of methanol and 16 volumes of acetonitrile as the mobile phase with a flow rate of 1.0ml per minute and a detection wavelength of 291nm. The number of theoretical plates of the column must no le than 2000, calculated on sildenafil Citrate.
Aay: Diolve the substance being examined with methanol and dilute it to 1.5mg/ml with the same solvent (Solution A). Diolve the reference substance with methanol and dilute it to 15μg/ml with the same solvent(Solution B). Inject 20μl of Solution B and adjust the sensitivity of the detector so that the high of principal peak in chromatogram obtained with solution B is 20% to 25% of full-scale deflection on the chart paper, then inject 20μl of Solution A and record the chromatograms for 2 times the retention time of principal peak. The sum of peck areas due to impurities is no greater than 1% of the total peak areas, if there are any secondary peaks in the chromatograms obtained with Solution A.
Lo on drying When dried to constant weight at 105℃,loses not more than 2.5% of its weight(AppendixⅡVIIIL,C.P.95).
Residue on ignition Using 1g, in a platinum crucible, not more than 0.1% (AppendixⅡVIIIN,C.P.95).
Heavy metals Carry out the limit test for heavy metal(AppendixⅡVIIIH,C.P.95), using the residue obtained in Residue on ignition; not more than 20ppm.
Aay Diolve about 0.25g, weigh accurately, in 30ml of glacial acetic acid and 10ml acetic anhydride, and add 1 drop of crystal violet IS. Titrate with perchloric acid(0.1mol/L) VS until the solution becomes yellowish-green, and the color changes to yellow after 30s. Perform a blank determination and make any neceary correction. Each ml of perchloric acid(0.1mol/L) VS is equivalent to 33.34mg of C22H30N6O4S-C6H8O7.
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ZHOUBIAN TRADING CO., LTD.
Zhou
202 Mailbox Daxing Building Guangqiao Street OCT Shenzhen PRC
518053
86-755-26949372
86-755-26600300
www.edta.cn
Zhou
202 Mailbox Daxing Building Guangqiao Street OCT Shenzhen PRC
518053
86-755-26949372
86-755-26600300
www.edta.cn
