標(biāo)準(zhǔn)品和對(duì)照品的區(qū)別:
☆對(duì)照品:用于鑒別、檢查、含量測(cè)定和校正檢定儀器性能的標(biāo)準(zhǔn)物質(zhì)。對(duì)照品系指用于生物制品理化等方面測(cè)定的特定物質(zhì),由生產(chǎn)單位采用與制品生產(chǎn)工藝相同的方法制備。對(duì)照品應(yīng)盡可能與制品原液配方一致,穩(wěn)定性較差的,可加不含對(duì)測(cè)定有干擾物質(zhì)的適宜的穩(wěn)定劑。對(duì)照品由國(guó)家藥品檢定機(jī)構(gòu)審查認(rèn)可,其標(biāo)準(zhǔn)應(yīng)不低于制品的質(zhì)量標(biāo)準(zhǔn)。
☆標(biāo)準(zhǔn)品:用于生物檢定、抗生素或生物藥品中含量或效價(jià)測(cè)定的標(biāo)準(zhǔn)物質(zhì),以效價(jià)單位(U)表示。國(guó)家標(biāo)準(zhǔn)品及生物參考品系指用于鑒別、檢查含量或效價(jià)測(cè)定的標(biāo)準(zhǔn)物質(zhì),其制備與標(biāo)定應(yīng)符合“生物制品國(guó)家標(biāo)準(zhǔn)物質(zhì)制備和標(biāo)定規(guī)程”要求,并由藥品監(jiān)督管理部門(mén)指定的機(jī)構(gòu)分發(fā)。企業(yè)工作標(biāo)準(zhǔn)品或參考品必須經(jīng)國(guó)家標(biāo)準(zhǔn)品或參考品標(biāo)化后方能使用。
產(chǎn)品名稱
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Drospirenone
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CAS號(hào)
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67392-87-4
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貨號(hào)
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BH-R11199
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Drospirenone
CAS No.: 67392-87-4
中文名: 屈螺酮
別名:
分子式: C24H30O3
性狀: Powder
純度: 98.0%
特色服務(wù): 隨貨提供1H-NMR等報(bào)告
關(guān)鍵詞:
訂購(gòu)須知:
產(chǎn)品僅用于科研客戶訂購(gòu)時(shí)需留下詳細(xì)的寄送信息;收到貨以后,請(qǐng)先驗(yàn)貨,看包裝有無(wú)破損,如有破損請(qǐng)不要簽收,并及時(shí)反饋給我們,我們會(huì)重新發(fā)貨;實(shí)驗(yàn)的過(guò)程中,請(qǐng)嚴(yán)格按照說(shuō)明書(shū)進(jìn)行操作,如遇技術(shù)問(wèn)題可與我司技術(shù)部咨詢。
對(duì)照品實(shí)驗(yàn)方法與判定:
1.對(duì)照品溶液的穩(wěn)定性
2.對(duì)照品溶液的配制:精密量取腦對(duì)照品適量,加無(wú)水乙醇制成每1ml含腦1mg的溶液,作為對(duì)照品溶液。
3.色譜條件:以交聯(lián)鍵合聚乙二醇為固定相的毛細(xì)管柱;柱溫120℃;進(jìn)樣口溫度250℃;檢測(cè)器溫度250℃;分流進(jìn)樣,分流比10:1。理論塔板數(shù)按腦計(jì)算應(yīng)不低于10000。
4.實(shí)驗(yàn)方法:配制的對(duì)照品溶液,一份置冷處保存,一份置室溫中保存,在第1、3、7、10、15天重新配制一份對(duì)照品溶液,三種儲(chǔ)備液同時(shí)稀釋制成每1ml中約含50ug的溶液。照氣相色譜法,并依據(jù)新對(duì)照品的峰面積計(jì)算原對(duì)照品溶液的含量。記錄下來(lái),保證原對(duì)照品溶液含量在考察期相對(duì)平均偏差不超過(guò)2.0%,驗(yàn)證對(duì)照品溶液在使用期內(nèi)穩(wěn)定可靠。
標(biāo)準(zhǔn)品的管理:
(一)接收
收到標(biāo)準(zhǔn)品后,應(yīng)檢查外包裝是否完好密封,標(biāo)簽是否清晰完整,并及時(shí)填好相關(guān)貯存記錄,記錄信息要完整無(wú)缺,至少要包括Drospirenone、儲(chǔ)存條件、存入日期、保質(zhì)期、規(guī)格、批號(hào)、含量、數(shù)量、瓶號(hào)以及備注信息等。
(二)貯存
對(duì)于標(biāo)準(zhǔn)品的存放期間,要經(jīng)常性的核查標(biāo)準(zhǔn)品是否失效,對(duì)于怕光怕熱易揮發(fā)的標(biāo)準(zhǔn)品,是否密封實(shí)了,是否按照存放要求進(jìn)行存放。
(三)使用
采用登記制度,如需要取用,則需要填寫(xiě)取用的產(chǎn)品名、對(duì)應(yīng)的批號(hào)、數(shù)量、使用目的、取用人等相關(guān)詳細(xì)的信息,以明確責(zé)任主體,保證能夠查到標(biāo)準(zhǔn)品使用的來(lái)龍去脈。
(四)銷毀
產(chǎn)品僅用于科研及時(shí)檢查基準(zhǔn)標(biāo)準(zhǔn)品是否過(guò)期,如有過(guò)期,需要收集起來(lái)及時(shí)做銷貨處理。
以下列是公司正在熱銷:
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關(guān)鍵字: Drospirenone;67392-87-4;98.0%;