藥品中的殘留溶劑系指在原料藥物或輔料的生產(chǎn)中,以及在制制備過(guò)程中使用的,但在工藝過(guò)程中未能完全除去的有機(jī)溶劑)根據(jù)有機(jī)溶劑的毒性,國(guó)際上已統(tǒng)一將殘留溶劑分為四類(lèi):第一類(lèi)溶劑是應(yīng)該避免使用的溶劑,毒性較大,一般為致癌物或危害環(huán)境的物質(zhì),共5種;第二類(lèi)溶劑是應(yīng)限制使用的溶劑，具有可逆毒性,對(duì)動(dòng)物有非基因毒性致癌性，或不可逆的神經(jīng)或致畸等毒性,共27種;第三類(lèi)溶劑是毒性低,對(duì)人體危害較小的溶劑,共27種;第四類(lèi)溶劑目前尚未有足夠毒理學(xué)資料證明對(duì)人體有害,共10種。除另有規(guī)定外,第一類(lèi)、第二類(lèi)、第三類(lèi)溶劑的殘留限度應(yīng)符合《中國(guó)藥典》(2020年版)的規(guī)定;對(duì)其他溶劑(包括第四類(lèi))應(yīng)根據(jù)生產(chǎn)工藝的特點(diǎn),制定相應(yīng)的限度,使其符合產(chǎn)品規(guī)范、《藥品生產(chǎn)質(zhì)量管理規(guī)范》(GMP)或其他基本的質(zhì)量要求。?
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系統(tǒng)適用性試驗(yàn)
(1)用待測(cè)物的色譜峰計(jì)算,填充柱法的理論板數(shù)應(yīng)大于1000;毛細(xì)管色譜柱的理論板數(shù)應(yīng)大于5000。?
(2)色譜圖中,待測(cè)物色譜峰與其相鄰的色譜峰的分離度應(yīng)大于1.5。
(3)以?xún)?nèi)標(biāo)法測(cè)定時(shí)，對(duì)照品溶液連續(xù)進(jìn)樣5次,所得待測(cè)物與內(nèi)標(biāo)物峰面積之比的相對(duì)標(biāo)準(zhǔn)偏差(RSD)應(yīng)不大于5%;若以外標(biāo)法測(cè)定，所得待測(cè)物峰面積的相對(duì)標(biāo)準(zhǔn)偏差(RSD)應(yīng)不大于10%。
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名稱(chēng)：毛細(xì)管柱
固定相：專(zhuān)用
規(guī)格：30m*0.53mm
型號(hào)：HH-TBS-30
應(yīng)用：藥典0861 殘留溶劑測(cè)定法，理論塔板數(shù)
適用于：安捷倫，島津，賽默飛，瓦里安，布魯克，PE
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浩瀚色譜（山東）應(yīng)用技術(shù)開(kāi)發(fā)有限公司研制的《藥典0861甲醇測(cè)定毛細(xì)管色譜柱理論塔板數(shù)》，柱效高，分離好，甲醇的理論塔板數(shù)可達(dá)408638，
丙酮的理論塔板數(shù)可達(dá)143384，滿(mǎn)足藥典溶劑殘留；；塔板數(shù)的要求。
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Residual solvents in drugs refer to organic solvents used in the production of raw materials or excipients, as well as in the preparation process, but not completely removed during the manufacturing process. According to the toxicity of organic solvents, residual solvents have been internationally classified into four categories: the first category of solvents should be avoided, which are highly toxic and generally carcinogenic or environmentally harmful substances, totaling five types; The second type of solvent is a solvent that should be restricted from use, with reversible toxicity, non genotoxic carcinogenicity to animals, or irreversible neurotoxicity or teratogenicity, totaling 27 types; The third type of solvent is low toxicity and less harmful to human health, with a total of 27 types; There is currently insufficient toxicological data to prove that the fourth type of solvent is harmful to human health, with a total of 10 types. Unless otherwise specified, the residual limits of Class I, II, and III solvents shall comply with the provisions of the Chinese Pharmacopoeia (2020 edition); For other solvents (including Class IV), corresponding limits should be established based on the characteristics of the production process to ensure compliance with product specifications, Good Manufacturing Practice (GMP), or other basic quality requirements. ?
System Applicability Test
(1) The theoretical number of plates for packed column method should be greater than 1000, calculated based on the chromatographic peak of the analyte; The theoretical number of plates for capillary chromatography columns should be greater than 5000. ?
(2) In the chromatogram, the separation degree between the chromatographic peak of the analyte and its adjacent peak should be greater than 1.5.
(3) When using the internal standard method for determination, the relative standard deviation (RSD) of the peak area ratio between the analyte and the internal standard obtained by continuously injecting the reference solution 5 times should not exceed 5%; If measured by external standard method, the relative standard deviation (RSD) of the peak area of the analyte obtained should not exceed 10%.
Name: Capillary Column
Fixed phase: Dedicated
Specification: 30m * 0.53mm
model: HH-TBS-30
Application: Pharmacopoeia 0861 Residual Solvent Determination Method, Theoretical Plate Count
Applicable to: Agilent, Shimadzu, Thermo Fisher, Varian, Brooke, PE
The "Pharmacopoeia 0861 Methanol Determination Capillary Chromatography Column Theoretical Plate Number" developed by Haohan Chromatography (Shandong) Application Technology Development Co., Ltd. has high column efficiency and good separation. The theoretical plate number of methanol can reach 408638,
The theoretical number of trays for acetone can reach 143384, which meets the requirements for residual solvents in pharmacopoeia;; Requirements for the number of tower plates.
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