1. ICH M7.Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_R1_Addendum_Step_4_2017_0331.pdf(accessed September 2020).
2. EMA Press Release. 5 July 2018.https://www.ema.europa.eu/en/news/ema‐reviewing‐medicines‐containing‐valsartan‐zhejiang‐huahai‐following‐detection‐impurity‐some(accessed September 2020).
3. FDA News Release.https://www.fda.gov/news‐events/press‐announcements/fda‐provides‐update‐its‐ongoing‐investigation‐valsartan‐products‐and‐reports‐finding‐additional(accessed September 2020).
4. FDA News Release.https://www.fda.gov/drugs/drug‐safety‐and‐availability/fda‐updates‐and‐press‐announcements‐angiotensin‐ii‐receptor‐blocker‐arb‐recalls‐valsartan‐losartan#5cc3b83d3b22e(accessed September 2020).
5. CHMP.List of questions to be addressed by the API manufacturers for valsartan‐containing medicinal products. Referral under Article 31 of Directive 2001/83/EC 16 July 2018 EMA/CHMP/466974/2018.