廣東雜質(zhì)有什么要求服務(wù)至上深圳振強(qiáng)生物技術(shù)供應(yīng)-b2b網(wǎng)站_b2b電子商務(wù)平臺(tái)【買產(chǎn)品】-上?？谄蚴称酚邢薰?/title><meta name="description" content="雜質(zhì)對(duì)消旋體藥物的質(zhì)量標(biāo)準(zhǔn)，必要時(shí)可以設(shè)旋光度檢查項(xiàng)目，廣東雜質(zhì)有什么要求。殘留溶劑，應(yīng)根據(jù)生產(chǎn)工藝中所用有機(jī)溶劑及其殘留情況，確定檢查項(xiàng)目?？蓞⒖急舅幍潢P(guān)于殘留溶劑的要求，或參考ICH文件Q3C(殘留溶劑指導(dǎo)原則）。對(duì)殘留的毒性溶劑，應(yīng)規(guī)"><meta name="keywords" content="廣東雜質(zhì)有什么要求,雜質(zhì)"><link rel="canonical" href="http://www.cdcfah.com/"/><meta name="applicable-device" content="pc"><link rel="shortcut icon" href="/static/new_net_01/images/favicon.ico"><link rel="stylesheet" href="/static/new_net_01/css/slick.css" /><link rel="stylesheet" href="/static/new_net_01/css/addnew.css"><link rel="stylesheet" href="/static/new_net_01/css/sidenav.css"><link rel="stylesheet" href="/static/new_net_01/css/style.css" /><link rel="stylesheet" href="/static/new_net_01/css/tab.css"><link rel="stylesheet" href="/static/new_net_01/css/404.css"> <meta 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clearfix"><section class="container clearfix tcPro"><section class="home-main container clearfix"><div id="s7q8axz" class="twoCol"><div id="sjvsug8" class="page-proshow clearfix"><p class="current"> 當(dāng)前位置:<a href="http://www.cdcfah.com/">首頁?<a href="http://www.cdcfah.com/cp/">產(chǎn)品供應(yīng)</a>?<a href="http://www.cdcfah.com/cp/first-_huagong/">化工</a>?<a href="http://www.cdcfah.com/cp/second-huagong_hgzjt/">化工中間體</a>?<a href="http://www.cdcfah.com/cp/third-hgzjt_yyzjtic/">醫(yī)藥中間體</a>?廣東雜質(zhì)有什么要求服務(wù)至上深圳振強(qiáng)生物技術(shù)供應(yīng)</p><div id="ox88w3k" class="leftbox clearfix"><h1>廣東雜質(zhì)有什么要求服務(wù)至上深圳振強(qiáng)生物技術(shù)供應(yīng)</h1><div id="pj39s9l" class="proBig"><div id="q8wbnp2" class="bigimg"><div><p class="pic"><img src="https://tyunfile.71360.com/UploadFile/SZZQSW/637395635939008260/9495435.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div><div id="rizpmyf" class="smallimg"><div><p class="pic"><img src="https://tyunfile.71360.com/UploadFile/SZZQSW/637395635939008260/9495435.png" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></p></div></div></div><div id="2uulikb" class="content"><p><span>需求數(shù)量：</span>0</p><p><span>價(jià)格要求：</span>面議</p><p><span>所在地：</span>廣東省</p><p><span>包裝要求：</span><span style="color: #f30;"></span></p><p><span>產(chǎn)品關(guān)鍵詞：</span>廣東雜質(zhì)有什么要求,雜質(zhì)</p><p><span>***更新：</span>2021-02-04 09:16:56</p><p><span id="click" >瀏覽次數(shù)：0次</span></p><a rel="nofollow" class="button">聯(lián)系我們</a></div></div><div id="t2dykmo" class="rightbox"><h3>公司基本資料信息</h3><p style="border:0;"><a rel="nofollow">深圳振強(qiáng)生物技術(shù)有限公司</a></p><p><span>聯(lián)系人：</span>顏佳</p><p><span>郵箱: </span>450804601@qq.com</p><p><span>電話: </span>15920483169</p><p><span>傳真: </span>0755_</p><p><span>網(wǎng)址: </span>http://www.chem-strong.com</p><p><span>手機(jī): </span>0755-66853366</p><p><span>地址: </span>龍崗街道南聯(lián)社區(qū)碧新路(龍崗段)2055號(hào)1201</p><p>[當(dāng)前離線] <a rel="nofollow"> [加為商友] </a><a rel="nofollow"> [發(fā)送信件] </a></p></div></div><div id="lxogdav" class="page-proshow02"><p class="title">詳細(xì)說明</p><div id="g22iczm" class="box"><p><p style="text-indent:25px">雜質(zhì)對(duì)消旋體藥物的質(zhì)量標(biāo)準(zhǔn)，必要時(shí)可以設(shè)旋光度檢查項(xiàng)目，廣東雜質(zhì)有什么要求。殘留溶劑，應(yīng)根據(jù)生產(chǎn)工藝中所用有機(jī)溶劑及其殘留情況，確定檢查項(xiàng)目。可參考本藥典關(guān)于殘留溶劑的要求，或參考ICH文件Q3C(殘留溶劑指導(dǎo)原則）。對(duì)殘留的毒性溶劑，應(yīng)規(guī)定其檢查項(xiàng)目。雜質(zhì)檢查分析方法和雜質(zhì)的限度雜質(zhì)檢查分析方法應(yīng)專屬、靈敏，廣東雜質(zhì)有什么要求。雜質(zhì)檢查應(yīng)盡量采用現(xiàn)代分離分析手段，廣東雜質(zhì)有什么要求，主成分與雜質(zhì)和降解產(chǎn)物均能分開，其檢測(cè)限應(yīng)滿足限度檢查的要求，對(duì)于需作定量檢查的雜質(zhì)，方法的定量限應(yīng)滿足相應(yīng)的要求。醫(yī)藥雜質(zhì)是藥品標(biāo)準(zhǔn)的物質(zhì)基礎(chǔ)。廣東雜質(zhì)有什么要求</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東雜質(zhì)有什么要求,雜質(zhì)" src="https://tyunfile.71360.com/UploadFile/SZZQSW/637395635939008260/9495435.png"></div><p style="text-indent:25px">雜質(zhì)與已有法定質(zhì)量標(biāo)準(zhǔn)規(guī)定不同，需增加新的雜質(zhì)檢查項(xiàng)目的，應(yīng)按上述方法進(jìn)行研究，申報(bào)新的質(zhì)量標(biāo)準(zhǔn)或?qū)υ|(zhì)量標(biāo)準(zhǔn)進(jìn)行修訂，并報(bào)有關(guān)藥品監(jiān)督管理部門審批。共存的異構(gòu)體和物質(zhì)多組分一般不作為雜質(zhì)檢查項(xiàng)目，作為共存物質(zhì)，必要時(shí)，在質(zhì)量標(biāo)準(zhǔn)中規(guī)定其比例，以保證生產(chǎn)用的原料藥與申報(bào)注冊(cè)時(shí)的一致性。但當(dāng)共存物質(zhì)為毒性雜質(zhì)時(shí)，該物質(zhì)就不再認(rèn)為是共存物質(zhì)。在單一對(duì)映體藥物中，可能共存的其他對(duì)映體應(yīng)作為雜質(zhì)檢查，并設(shè)比旋度項(xiàng)目；廣東雜質(zhì)有什么要求醫(yī)藥雜質(zhì)用于生物測(cè)定的物質(zhì)。</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東雜質(zhì)有什么要求,雜質(zhì)" src="https://tyunfile.71360.com/WaterMark/UploadFile/SZZQSW/637401870058375436/7904605.png"></div><p style="text-indent:25px">雜質(zhì)用于微量金屬元素的分析。在雜質(zhì)檢查中，主要是用于藥物中重金屬雜質(zhì)的檢查。通常采用標(biāo)準(zhǔn)加人法控制重金屬雜質(zhì)的限量：取供試品,按各品種項(xiàng)下的規(guī)定，制備供試品溶液：另取等量的供試品，加人限度量的待測(cè)元素溶液,制成中間溶液。設(shè)中間溶液的讀數(shù)為a，供試品溶液的讀數(shù)為b，b值應(yīng)小于(a-b)。例如維生素C中鐵鹽和銅鹽的檢查。物質(zhì)在加熱或冷卻過程中,會(huì)發(fā)生熔化、凝固、晶型轉(zhuǎn)變、分解化合、吸附、脫附等物理化學(xué)變化。這些變化必將伴隨體系焓(熱量的吸收或釋放)的改變，因而產(chǎn)生熱效應(yīng)。</p><p style="text-indent:25px">藥物與雜質(zhì)在物理性質(zhì)上的差異，主要指藥物與雜質(zhì)在外觀始分配或吸附以及對(duì)光的吸收等性質(zhì)的差別；在化學(xué)性質(zhì)上的差異，主要指藥物與雜質(zhì)對(duì)某學(xué)反應(yīng)的差別，一般地，是雜質(zhì)與試劑反應(yīng)，而藥物不反應(yīng)。根據(jù)雜質(zhì)的控制要求，可以進(jìn)行量檢查，也可以對(duì)雜質(zhì)進(jìn)行定量測(cè)定。制藥企業(yè)應(yīng)該按照經(jīng)國家藥品監(jiān)督管理部門依法審查批準(zhǔn)的規(guī)定工藝和規(guī)定原輔料進(jìn)行藥品的生產(chǎn)，如果變更生產(chǎn)工藝或原輔料，并由此而帶進(jìn)新的雜質(zhì)，需對(duì)原質(zhì)量標(biāo)準(zhǔn)進(jìn)行修訂。醫(yī)藥雜質(zhì)在藥品行業(yè)有舉足輕重的地位.</p><div style="width:100%;text-align: center;"><img style="max-width: 640px; max-height: 320px;" alt="廣東雜質(zhì)有什么要求,雜質(zhì)" src="https://tyunfile.71360.com/UploadFile/SZZQSW/637395635888021892/8032121.png"></div><p style="text-indent:25px">雜質(zhì)吸附以及對(duì)光的吸收等性質(zhì)的差別;在化學(xué)性質(zhì)上的差異,主要指藥物與雜質(zhì)對(duì)某學(xué)反應(yīng)的差別,一般地,是雜質(zhì)與試劑反應(yīng),而藥物不反應(yīng)。根據(jù)雜質(zhì)的控制要求,可以進(jìn)行量檢查,也可以對(duì)雜質(zhì)進(jìn)行定量測(cè)定。雜質(zhì)限度的制訂應(yīng)考慮如下因素:① 雜質(zhì)及含一定限量雜質(zhì)的藥品的毒理學(xué)研究結(jié)果;給藥途徑;每日劑量;② 醫(yī)治周期;給藥人群;雜質(zhì)藥理學(xué)可能的研究結(jié)果;原料藥的來源;③ 在保證安全有效的前提下,藥品生產(chǎn)企業(yè)對(duì)生產(chǎn)高質(zhì)量藥品所需成本和消費(fèi)者對(duì)藥品價(jià)格的承受力,等。醫(yī)藥雜質(zhì)用于相關(guān)的藥品標(biāo)準(zhǔn)鑒別。廣東雜質(zhì)有什么要求</p><p style="text-indent:25px">醫(yī)藥雜質(zhì)用于中藥材、中藥飲片的含量測(cè)定的標(biāo)準(zhǔn)物質(zhì)。廣東雜質(zhì)有什么要求</p><p style="text-indent:25px">如注射用雜質(zhì)在105℃干燥減失重量不得過1.0%。不需中間體。藥物中的所有雜質(zhì)都會(huì)不同程度地影響藥物的穩(wěn)定性和安全性,因此有必要在藥物的生產(chǎn)和貯存過程中嚴(yán)格的控制藥物雜質(zhì)的含量,雜質(zhì)檢查是控制藥物質(zhì)量的一項(xiàng)重要指標(biāo)。藥物的雜質(zhì)檢查分為一般雜質(zhì)檢查和特殊雜質(zhì)檢查。1.一般雜質(zhì)檢查對(duì)于一般雜質(zhì)的檢查,中國藥典規(guī)定了氯化物、硫酸鹽、硫化物、硒、氟、**物、鐵鹽、重金屬、砷鹽、銨鹽以及酸堿度、澄清度、溶液的顏色、干燥失重、水分、熾灼殘?jiān)?、易炭化物、有機(jī)溶劑殘留量等項(xiàng)目的檢查方法及限度。廣東雜質(zhì)有什么要求</p></p><br /><p>文章來源地址: http://www.cdcfah.com/cp/3158353.html</p></div></div></div></div></div><div id="ea8tact" class="page-right twoColRt"><div id="ujl773u" class="box01 margin10 clearfix"><h3><a href="http://www.cdcfah.com/cp/">猜你喜歡</a></h3><div id="8nz3rbc" class="recomPic likePro"><a href="http://www.cdcfah.com/cp/814588.html"><div><img src="http://tyunfile.71360.com/UpLoadFile/2019/11/1/14/637082168864691056_lgpj_5374157.jpg" alt="福建ZF配件哪家強(qiáng) 信息推薦自業(yè)物資供應(yīng)" class="vcenter" onerror="javascript:this.src='/static/new_net_01/images/nopic.jpg';"></div><p>福建ZF配件哪家強(qiáng) 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