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Signs of contamination or degradation: Cloudiness or turbidity (potential bacterial growth or precipitation) Visible particles or crystals (potential contamination or degradation products) Discolouration or browning (potential oxidative degradation) Visible mould growth (rare, but indicates severe contamination) Unpleasant or unusual odour (potential bacterial contamination) Action: If any of these signs are observed, discard the vial immediately
To regulate and guide the research and evaluation of nanomedicine, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration formulated the Technical Guidelines for Nanomedicines Non-Clinical Safety Evaluation Research (Trial), which was issued in August 2021 ( in vitro or in vivo or an alternative toxicity testing method, and also reminded to carefully choose the dose and testing time period
However, due to limited human clinical trials, long-term safety is not fully understood
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