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의약품 중 잠재적 불순물 관리를 위한 분석법 연구 동향
Analytical methods to manage potential impurities in drug substances
분석과학 / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2022, v.35 no.3, pp.93-115
https://doi.org/10.5806/AST.2022.35.3.93
(경희대학교 약학대학)
(경희대학교 약학대학)
(경희대학교 약학대학)
(경희대학교 약학대학)
(경희대학교 약학대학)
(우석대학교 약학대학)
(경희대학교)
(경희대학교 약학대학)
(경희대학교 약학대학)
(경희대학교 약학대학)
(경희대학교 약학대학)
(우석대학교 약학대학)
(경희대학교)
박경민,
김원미,
안수현,
이하림,
황수현,
이원웅,
&
홍종기.
(2022). 의약품 중 잠재적 불순물 관리를 위한 분석법 연구 동향. 분석과학, 35(3), 93-115, https://doi.org/10.5806/AST.2022.35.3.93
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초록
의약품의 제조, 유통, 보관 과정에서 발생할 수 있는 잠재적 불순물은 의약품의 품질과 안전에영향을 미치며 반응성이 높은 불순물의 경우 인체에 대한 발암성(변이원성)을 나타내기도 한다. 이를 위해 국제의약품규제조화위원회(International Conference on Harmonisation, ICH)에서는 “잠재적 발암 위해를 제한하기 위한 의약품 중 DNA 반응성(변이원성) 불순물의 평가 및 관리”에 대한 내용을 담은 M7(R1) 가이드라인을 제공하여 채택을 권고하였다. 하지만 가이드라인에서도 잠재적 불순물에 대한 분류, 섭취허용량, 관리방안 등과 대표적인 불순물 14종에 대한 가이드라인 적용을 소개하는데 그치고 있어 제약회사와 규제 당국에서 실제 관리를 위한 의약품 중 잠재적 불순물의 분석에 어려움을 겪고 있다. 이에 따라 본 총설에서는 비의도적 변이원성 불순물의 정의와 ICH M7(R1) 가이드라인에 소개된 내용을 간략하게 살펴보는 한편 현재까지 보고된 주요 잠재적 불순물의 분석 동향을 살펴보고자 한다. 이를 통해 식약처를 비롯한 감독 기관과 제약회사 등에서 의약품 중 잠재적 불순물 관리에 조금이나마 도움이 되고자 한다.
- keywords
- potential impurity, mutagenic (carcinogenic) impurity, active pharmaceutical ingredient, drug substance, ICH M7(R1), analytical method
Abstract
Potential impurities in pharmaceuticals could be produced during manufacture, distribution, and storage and affect quality and safety of pharmaceuticals. In particular, highly reactive impurities could result in carcinogenic (mutagenic) effects on human body. International Conference on Harmonisation (ICH) has provided M7(R1) guideline for “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and recommended an adoption of this guideline to the authorities. ICH M7(R1) guideline provides classification, accepted intakes, and controls of potential impurities in pharmaceuticals. However, since appropriate and unified analytical methods for impurities in pharmaceuticals have not been provided in this guideline, most potential impurities in pharmaceuticals are still difficult to manage and supervise by pharmaceutical companies and regulatory authorities, respectively. In this review, we briefly described definition of unintended mutagenic impurities, basic information in ICH M7(R1) guideline, and analytical methods to determine potential impurities. This review would be helpful to manage and supervise potential impurities in pharmaceuticals by pharmaceutical companies and regulatory authorities.
- keywords
- potential impurity, mutagenic (carcinogenic) impurity, active pharmaceutical ingredient, drug substance, ICH M7(R1), analytical method
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