Allopurinol EP Impurity A, すなわち Allopurinol Related Compound A は、キサンチンオキシダーゼ阻害薬アロプリノールに由来する工程起源および分解起源の規定不純物であり、ニトロソアミンや一般的な遺伝毒性不純物ではなく、複素芳香族の酸化体または転位体に相当する。CAS 5334-31-6、分子式 C4H6N4O、分子量 126.12 g/mol である。薬局方規格および ICH Q3A/Q3B に基づく不純物管理に関連し、微量定量には通常 LC-MS/MS、高分解能 LC-MS、ならびに UV またはダイオードアレイ検出を用いる直交 HPLC が必要で、単離可能な場合は NMR により構造確認を行う。
References
Murrell, G. A. C., and W. G. Rapeport. “Clinical Pharmacokinetics of Allopurinol.†Clinical Pharmacokinetics, vol. 11, no. 5, 1986, pp. 343–53, https://doi.org/10.2165/00003088-198611050-00001.?Osabe, Makoto, et al. “In Silico Analysis of Interactions between HLA-B*58:01 and Allopurinol-Related Compounds.†Chem-Bio Informatics Journal, vol. 16, no. 0, 2016, pp. 1–4, https://doi.org/10.1273/cbij.16.1.?
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