여름정기학술대회
2022여름초록
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Identifying impurities is of paramount importance in the process of producing active pharmaceutical ingredients (API) and synthetic drug products. Following the announcement of the recall due to the discovery of impurities in Sartan drugs, detection methods for quickly and accurately monitoring various impurities in the drug production process are required. Benzyl chloride is one of the representative carcinogen that might be produced in the production process of Cinnarizine. Therefore, it is important to develop an analysis method that can detect and quantify benzyl chloride to the low parts-per-billion level. In this study, we developed and validated an analysis method using solvent-free headspace gas chromatography-mass analysis (SF-HS-GC/MS) for benzyl chloride screening in different products such as active pharmaceutical ingredients (API), capsules, and tablets.This method has been validated in accordance with the Q2(R1) ICH guidelines. SF-HS-GC/MS system conditions were optimized using incubation temperature and incubation time. The calibration curve showed good linearity in the range of 4 to 200 μg/g with the correlation coefficient (R2>0.998) including benzyl chloride 4 μg/g. The developed method has an accuracy of 90.80 to 118.01% and an accuracy (%RSD) of 0.34 to 3.67%. In conclusion, the developed SF-HS-GC/MS method has been successfully applied to benzyl chloride measurements in API and drug products.
*This research was supported by a grant (20173MFDS162) from Ministry of Food and Drug Safety in 2022.
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