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| SN/T 1951-2007 | English | 679 |
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Determination of vardenafil, sildenafil and tadalafil in health foods for import and export. LC-MS/MS method
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SN/T 1951-2007
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Basic data | Standard ID | SN/T 1951-2007 (SN/T1951-2007) | | Description (Translated English) | Determination of vardenafil, sildenafil and tadalafil in health foods for import and export. LC-MS/MS method | | Sector / Industry | Commodity Inspection Standard (Recommended) | | Classification of Chinese Standard | X04 | | Classification of International Standard | 67.050 | | Word Count Estimation | 17,146 | | Date of Issue | 2007-08-06 | | Date of Implementation | 2008-03-01 | | Regulation (derived from) | National-accreditation-Science [2011] 63 | | Issuing agency(ies) | General Administration of Customs | | Summary | This standard specifies the health food vardenafil, sildenafil, tadalafil liquid chromatography mass spectrometry/mass spectrometry. This standard applies to tablets, capsules and oral solution type of health food vardenafil, sildenafil, tadalafil is detected. | SN/T 1951-2007: Determination of vardenafil, sildenafil and tadalafil in health foods for import and export. LC-MS/MS method
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Determination of vardenafil, sildenafil and tadalafil in health foods for import and export.LC-MS/MS method
Exit inspection and quarantine industry standard book People's Republic of China
Import and export of health food in vardenafil, sildenafil,
Tadalafil detection method
Liquid chromatography - mass spectrometry/mass spectrometry
Posted 2007-08-06
2008-03-01 implementation
People's Republic of China
The State Administration of Quality Supervision, Inspection and Quarantine released
Foreword
The Standard Appendix A and Appendix B are informative.
This standard is proposed and managed by the National Certification and Accreditation Administration Committee.
This standard was drafted by the People's Republic of China Hunan Exit Inspection and Quarantine.
The main drafters of this standard. Mei-ling, Wan sunny, Dai Hua, Li Yongjun, OF SCIENTIFIC Wangxiang Xian, Huang Ping.
This standard is the first release of the entry-exit inspection and quarantine industry standards.
Import and export of health food in vardenafil, sildenafil,
Tadalafil detection method
Liquid chromatography - mass spectrometry/mass spectrometry
1 Scope
This standard specifies the health foods vardenafil, sildenafil, tadalafil liquid chromatography - mass spectrometry/mass spectrometry methods.
This standard applies to tablets, capsules and oral liquid health food in vardenafil, sildenafil, tadalafil detection.
2 Determination
2.1 Method summary
Tablets, capsules in a sample vardenafil, sildenafil, tadalafil ultrasonic methanol extract, extracted liquid diluted and filtered. oral
After diluted solutions direct filtration, with electrospray ionization liquid chromatography - mass spectrometry/mass spectrometer measurement, external standard.
2.2 Reagents and materials
All reagents unless otherwise specified, were of analytical grade, double distilled water.
2.2.1 acetonitrile. HPLC fractions.
2.2.2 Methanol. HPLC fractions.
2.2.3 glacial acetic acid. pure class distinctions.
2.2.4 hydrochloride. pure class distinctions.
2.2.5 0.1mol/L hydrochloric acid + methanol mixture (9 + 1, volume ratio).
2.2.6 Vardenafil (vardenafil, CAS number. 224785-90-4, molecular formula. C23H32N6O4S · HCl · 3H2O) Standard. Purity
Not less than 99.5%.
2.2.7 sildenafil (Sildenafil, CAS number. 139755-83-2, molecular formula. C22H30N6O4S) Standard. purity greater than or equal
99.5%.
2.2.8 tadalafil (tadalafil, CAS number. 171596-29-5, molecular formula. C22H19N3O4) standard. not less than 99.5% purity.
2.2.9 Standard solution. namely, accurately weighed amount vardenafil, sildenafil, tadalafil non-standard products, prepared in methanol concentration
Mixed standard stock solution 10μg/mL, and stored at 4 ℃. As required by 0.1mol/L hydrochloric acid + methanol mixture (2.2.5) will be marked
Quasi stock solution diluted to working standard 1ng/mL, 2ng/mL, 4ng/mL, 10ng/mL, 50ng/mL, 100ng/mL of
Solution.
2.3 instruments and equipment
2.3.1 High performance liquid chromatography - mass spectrometry/mass spectrometry. triple quadrupole mass detector, distribution ionization (ESI).
2.3.2 ultrasonic cleaner.
2.3.3 vortex shaker.
2.3.4 Electronic balance. a sense of the amount of 1mg.
2.3.5 mortar.
2.4 Determination of step
2.4.1 Preparation of the sample
2.4.1.1 tablets
Randomly selected from the same batch of test 20, small study of a sample.
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