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Analysis of five nitrosamines in sartan drugs using the published GC-MS/MS FDA method
| Chinese (Simplified) (China) | Complete (PDF) |
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| Korean (Korea) | Complete (PDF) |
| Japanese (Japan) | Complete (PDF) |
A GC/FID/MSD method for the residual solvents.
| Korean (Korea) | Complete (PDF) |
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| Chinese (Simplified) (China) | Complete (PDF) |
Extractables were identified in pressurized metered dose inhaler components using two Agilent 5977A Series GC/MSD Systems.
GC/Q-TOF MS data was used for identification and quantitation, while MSMS data was used to predict the impuriy fragment structures using MSC software.
| Korean (Korea) | Complete (PDF) |
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Plasticizers were identified in drug suspension using headspace GC/MS and MMI GC/MS. SIM confirmed the identification of phthalate and fatty acid plasticizers.
| Korean (Korea) | Complete (PDF) |
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| Chinese (Simplified) (China) | Complete (PDF) |
propylene oxide impurities were analyzed with low method-detection limit, good resolution, sample recovery, and repeatability using Agilent J&W PoraBOND U.