A RP-HPLC Method for the Analysis of Neostigmine Methylsulfate and Process-Related Impurities, Forced Degradation Studies, in the Injection Formulation

<table class="table-group" id="tab12"><tr><td><table class="table"><tr><td class="thead-hr" colspan="4"><hr/></td></tr><tr class="thead"><td class="align_left">NMS injection formulation</td><td class="align_center">Controlled pack</td><td class="align_center">Primary pack</td><td class="align_center">Secondary pack</td></tr><tr><td class="thead-hr" colspan="4"><hr/></td></tr><tr><td class="align_left">(%) <svg height="11.439pt" id="M23" style="vertical-align:-2.15067pt" version="1.1" viewbox="-0.0498162 -9.28833 24.0571 11.439" width="24.0571pt" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink"><g transform="matrix(.013,0,0,-0.013,0,0)"><path d="M689 332C689 394 670 448 646 448C620 448 597 421 597 396C597 386 600 381 608 372C619 359 620 334 620 315C620 150 538 45 454 45C414 45 386 67 386 122C386 138 388 158 394 180L457 426L452 432L377 416L315 156C302 100 259 45 216 45C176 45 148 67 148 122C148 133 152 158 156 180C162 212 173 259 194 332C201 357 206 384 206 405C206 430 198 448 174 448C125 448 66 406 23 342L43 319C84 368 110 383 121 383C126 383 128 382 128 377C128 370 127 359 122 343C99 268 84 204 77 156C74 137 70 111 70 104C70 25 125 -12 180 -12C228 -12 276 12 319 50C338 8 378 -12 418 -12C549 -12 689 166 689 332Z"></path></g><g transform="matrix(.013,0,0,-0.013,9.257,0)"><path d="M368 703H309L44 -163H104L368 703Z"></path></g><g transform="matrix(.013,0,0,-0.013,14.618,0)"><path d="M689 332C689 394 670 448 646 448C620 448 597 421 597 396C597 386 600 381 608 372C619 359 620 334 620 315C620 150 538 45 454 45C414 45 386 67 386 122C386 138 388 158 394 180L457 426L452 432L377 416L315 156C302 100 259 45 216 45C176 45 148 67 148 122C148 133 152 158 156 180C162 212 173 259 194 332C201 357 206 384 206 405C206 430 198 448 174 448C125 448 66 406 23 342L43 319C84 368 110 383 121 383C126 383 128 382 128 377C128 370 127 359 122 343C99 268 84 204 77 156C74 137 70 111 70 104C70 25 125 -12 180 -12C228 -12 276 12 319 50C338 8 378 -12 418 -12C549 -12 689 166 689 332Z"></path></g></svg> of Impurity A</td><td class="align_center">0.10</td><td class="align_center">0.10</td><td class="align_center">0.02</td></tr><tr><td class="align_left">(%) <svg height="11.439pt" id="M24" style="vertical-align:-2.15067pt" version="1.1" viewbox="-0.0498162 -9.28833 24.0571 11.439" width="24.0571pt" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink"><g transform="matrix(.013,0,0,-0.013,0,0)"><path d="M689 332C689 394 670 448 646 448C620 448 597 421 597 396C597 386 600 381 608 372C619 359 620 334 620 315C620 150 538 45 454 45C414 45 386 67 386 122C386 138 388 158 394 180L457 426L452 432L377 416L315 156C302 100 259 45 216 45C176 45 148 67 148 122C148 133 152 158 156 180C162 212 173 259 194 332C201 357 206 384 206 405C206 430 198 448 174 448C125 448 66 406 23 342L43 319C84 368 110 383 121 383C126 383 128 382 128 377C128 370 127 359 122 343C99 268 84 204 77 156C74 137 70 111 70 104C70 25 125 -12 180 -12C228 -12 276 12 319 50C338 8 378 -12 418 -12C549 -12 689 166 689 332Z"></path></g><g transform="matrix(.013,0,0,-0.013,9.257,0)"><path d="M368 703H309L44 -163H104L368 703Z"></path></g><g transform="matrix(.013,0,0,-0.013,14.618,0)"><path d="M689 332C689 394 670 448 646 448C620 448 597 421 597 396C597 386 600 381 608 372C619 359 620 334 620 315C620 150 538 45 454 45C414 45 386 67 386 122C386 138 388 158 394 180L457 426L452 432L377 416L315 156C302 100 259 45 216 45C176 45 148 67 148 122C148 133 152 158 156 180C162 212 173 259 194 332C201 357 206 384 206 405C206 430 198 448 174 448C125 448 66 406 23 342L43 319C84 368 110 383 121 383C126 383 128 382 128 377C128 370 127 359 122 343C99 268 84 204 77 156C74 137 70 111 70 104C70 25 125 -12 180 -12C228 -12 276 12 319 50C338 8 378 -12 418 -12C549 -12 689 166 689 332Z"></path></g></svg> of unknown impurities</td><td class="align_center">0.13</td><td class="align_center">0.13</td><td class="align_center">0.06</td></tr><tr><td class="align_left">(%) <svg height="11.439pt" id="M25" style="vertical-align:-2.15067pt" version="1.1" viewbox="-0.0498162 -9.28833 24.0571 11.439" width="24.0571pt" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink"><g transform="matrix(.013,0,0,-0.013,0,0)"><path d="M689 332C689 394 670 448 646 448C620 448 597 421 597 396C597 386 600 381 608 372C619 359 620 334 620 315C620 150 538 45 454 45C414 45 386 67 386 122C386 138 388 158 394 180L457 426L452 432L377 416L315 156C302 100 259 45 216 45C176 45 148 67 148 122C148 133 152 158 156 180C162 212 173 259 194 332C201 357 206 384 206 405C206 430 198 448 174 448C125 448 66 406 23 342L43 319C84 368 110 383 121 383C126 383 128 382 128 377C128 370 127 359 122 343C99 268 84 204 77 156C74 137 70 111 70 104C70 25 125 -12 180 -12C228 -12 276 12 319 50C338 8 378 -12 418 -12C549 -12 689 166 689 332Z"></path></g><g transform="matrix(.013,0,0,-0.013,9.257,0)"><path d="M368 703H309L44 -163H104L368 703Z"></path></g><g transform="matrix(.013,0,0,-0.013,14.618,0)"><path d="M689 332C689 394 670 448 646 448C620 448 597 421 597 396C597 386 600 381 608 372C619 359 620 334 620 315C620 150 538 45 454 45C414 45 386 67 386 122C386 138 388 158 394 180L457 426L452 432L377 416L315 156C302 100 259 45 216 45C176 45 148 67 148 122C148 133 152 158 156 180C162 212 173 259 194 332C201 357 206 384 206 405C206 430 198 448 174 448C125 448 66 406 23 342L43 319C84 368 110 383 121 383C126 383 128 382 128 377C128 370 127 359 122 343C99 268 84 204 77 156C74 137 70 111 70 104C70 25 125 -12 180 -12C228 -12 276 12 319 50C338 8 378 -12 418 -12C549 -12 689 166 689 332Z"></path></g></svg> of total impurities</td><td class="align_center">0.24</td><td class="align_center">0.23</td><td class="align_center">0.09</td></tr><tr class="table-tr"><td colspan="4"><hr class="tbody-hr"/></td></tr></table></td></tr></table>

<div>Accelerated photostability study of NMS injection studied for 10 days using three pack types.</div>

International Journal of Analytical Chemistry

tab12

Table 12

Table 12: A RP-HPLC Method for the Analysis of Neostigmine Methylsulfate and Process-Related Impurities, Forced Degradation Studies, in the Injection Formulation 

Table 12 | A RP-HPLC Method for the Analysis of Neostigmine Methylsulfate and Process-Related Impurities, Forced Degradation Studies, in the Injection Formulation 