التفاصيل البيبلوغرافية
| العنوان: |
Development and Validation of a Solvent-Free Headspace GC-MS Method for the Screening of Benzyl Chloride in Pharmaceutical Products |
| المؤلفون: |
Eunchae Song, Chanhong Min, Eunjae Kim, Sang Beom Han, Yong-Moon Lee, Kwang-Hyeon Liu, Jongki Hong, Han Bin Oh |
| المصدر: |
Chemosensors, Vol 11, Iss 9, p 487 (2023) |
| بيانات النشر: |
MDPI AG, 2023. |
| سنة النشر: |
2023 |
| المجموعة: |
LCC:Biochemistry |
| مصطلحات موضوعية: |
benzyl chloride, cinnarizine, ICH M7, impurity, solvent-free HS-GC/MS, Biochemistry, QD415-436 |
| الوصف: |
This study presents a solvent-free headspace gas chromatography–mass spectrometry (SF-HS-GC/MS) method for robustly screening benzyl chloride, a mutagenic carcinogen, impurities in active pharmaceutical ingredients (APIs) and drug products. The SF-HS-GC/MS method simplifies analysis by eliminating solvent use, reducing matrix interference. Optimized headspace parameters include incubation temperature, time, and sample amount. Validation, aligned with Q2(R1) ICH guidelines and ICH M7 recommendations, covers selectivity, linearity, limit of detection (LOD), limit of quantification (LOQ), precision, accuracy, system suitability, and robustness. Employing a DB-5MS column (30 m × 0.25 mm, 0.25 µm) with solvent-free split injection, the method’s calibration curve (0.05–5 μg/g) exhibits a strong correlation (>0.9998). The LOQ was 0.1 μg/g, with precision (%CV) consistently |
| نوع الوثيقة: |
article |
| وصف الملف: |
electronic resource |
| اللغة: |
English |
| تدمد: |
2227-9040 |
| Relation: |
https://www.mdpi.com/2227-9040/11/9/487; https://doaj.org/toc/2227-9040 |
| DOI: |
10.3390/chemosensors11090487 |
| URL الوصول: |
https://doaj.org/article/e60fc4517b924371afbcfa0cccf9e0b0 |
| رقم الانضمام: |
edsdoj.60fc4517b924371afbcfa0cccf9e0b0 |
| قاعدة البيانات: |
Directory of Open Access Journals |