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    藥物穩定性實驗室與藥品的有效期


    藥物穩定性實驗室與藥品的有效期

    大家都知道,藥品的穩定性試驗包括影響因素、加速試驗和長期留樣試樣。影響因素試驗的目的是明確藥品可能的降解途徑、初步確定藥品的包裝、貯藏條件和加速試驗的條件,同時驗證處方的合理性和分析方法的可行性;加速試驗的目的是明確藥品在偏離正常貯藏條件下的降解情況、確定長期留樣試樣的條件,長期穩定性試驗的目的是確認影響因素試驗和加速試驗的結果,明確藥品穩定性的變化情況,確定藥品的有效期,應該說長期留樣試樣是穩定性試驗的核心。


    我們在進行環儀藥品穩定性實驗室試驗的時候,要注意溫濕度。因為不同國家和地區的氣候條件的不同,長期留樣試驗的條件主要依據藥品注冊國家或地區的氣候條件,若藥品在全球上市或者銷售的地域氣候差別較大,其穩定性試驗應在盡可能多的國家和地區進行。因為溫度和濕度的變化將會影響藥品的有效期,每個氣候區產品的有效期是根據相應的穩定性試驗結果確定的,雖然每個氣候區的平均熱力學溫度在設定時已經將該氣候區一年的溫度波動考慮在內,但因一些產品對短時間內較高的溫度敏感。因此這類對溫度敏感的產品溫度要求明確存儲溫度的上限。

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