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澄清度檢查法之儀器法的方法學(xué)研究

發(fā)布時間:2018-05-12 17:39

  本文選題:澄清度檢查法 + 儀器法。 參考:《中國藥品標(biāo)準(zhǔn)》2016年04期


【摘要】:目的:建立澄清度檢查法之儀器法。方法:參照《歐洲藥典》溶液澄清度和濁度級別中的儀器法,采用三臺國內(nèi)外生產(chǎn)的濁度計進(jìn)行方法學(xué)研究,對線性、穩(wěn)定性和重復(fù)性進(jìn)行考察,同時對有色溶液的澄清度檢查是否適用于儀器法也進(jìn)行考察。結(jié)果:散射光式濁度儀適用于對無色溶液進(jìn)行濁度測定,線性、穩(wěn)定性和重復(fù)性均符合要求;現(xiàn)有濁度計無法消除有色溶液中的顏色對濁度值測定的干擾。結(jié)論:現(xiàn)有散射光式濁度計適用于無色溶液的濁度值測定,對目視法無法有效判斷的樣品提供了補(bǔ)充檢測方法。
[Abstract]:Objective: to establish an instrument method for clarification examination. Methods: referring to the instrumental method in the clarification and turbidity grade of the solution of the European Pharmacopoeia, three turbidimeters produced at home and abroad were used to study the methodology, and the linearity, stability and repeatability were investigated. At the same time, the clarity of the colored solution is also investigated. Results: the scattering-light turbidimeter is suitable for the turbidity measurement of colorless solution, the linearity, stability and repeatability are all in line with the requirement, and the existing turbidimeter can not eliminate the interference of the color in the colored solution to the determination of the turbidity value. Conclusion: the existing scattering turbidimeter is suitable for the determination of turbidity in colorless solution and provides a supplementary method for the determination of samples which cannot be effectively judged by visual method.
【作者單位】: 北京市藥品檢驗所;
【分類號】:R927.1

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相關(guān)期刊論文 前1條

1 高燕霞,張哲峰;對《中國藥典》中藥品溶液澄清度檢查法的商榷[J];中國藥事;1997年05期

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本文編號:1879522

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