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,并及時填好相關(guān)貯存記錄,記錄信息要完整無缺,至少要包括Ethynyl estradiol、儲存條件、存入日期、保質(zhì)期、規(guī)格、批號、含量、數(shù)量、瓶號以及備注信息等。
(二)貯存
對于標(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,對于怕光怕熱易揮發(fā)的標(biāo)準(zhǔn)品,是否密封實了,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,則需要填寫取用的產(chǎn)品名、對應(yīng)的批號、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)品使用的來龍去脈。
(四)銷毀
產(chǎn)品僅用于科研及時檢查基準(zhǔn)標(biāo)準(zhǔn)品是否過期,如有過期,需要收集起來及時做銷貨處理。
產(chǎn)品名稱
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Ethynyl estradiol
|
CAS號
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57-63-6
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貨號
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BH-R11190
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Ethynyl estradiol
CAS No.: 57-63-6
中文名: 炔雌醇
別名:
分子式: C20H24O2
性狀: Powder
純度: 98.0%
特色服務(wù): 隨貨提供1H-NMR等報告
關(guān)鍵詞:
標(biāo)準(zhǔn)品和對照品的區(qū)別:
☆對照品:用于鑒別、檢查、含量測定和校正檢定儀器性能的標(biāo)準(zhǔn)物質(zhì)。對照品系指用于生物制品理化等方面測定的特定物質(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,可加不含對測定有干擾物質(zhì)的適宜的穩(wěn)定劑。對照品由國家藥品檢定機(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測定的標(biāo)準(zhǔn)物質(zhì),以效價單位(U)表示。國家標(biāo)準(zhǔn)品及生物參考品系指用于鑒別、檢查含量或效價測定的標(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)國家標(biāo)準(zhǔn)品或參考品標(biāo)化后方能使用。
對照品實驗方法與判定:
1.對照品溶液的穩(wěn)定性
2.對照品溶液的配制:精密量取腦對照品適量,加無水乙醇制成每1ml含腦1mg的溶液,作為對照品溶液。
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℃;檢測器溫度250℃;分流進(jìn)樣,分流比10:1。理論塔板數(shù)按腦計算應(yīng)不低于10000。
4.實驗方法:配制的對照品溶液,一份置冷處保存,一份置室溫中保存,在第1、3、7、10、15天重新配制一份對照品溶液,三種儲備液同時稀釋制成每1ml中約含50ug的溶液。照氣相色譜法,并依據(jù)新對照品的峰面積計算原對照品溶液的含量。記錄下來,保證原對照品溶液含量在考察期相對平均偏差不超過2.0%,驗證對照品溶液在使用期內(nèi)穩(wěn)定可靠。
訂購須知:
產(chǎn)品僅用于科研客戶訂購時需留下詳細(xì)的寄送信息;收到貨以后,請先驗貨,看包裝有無破損,如有破損請不要簽收,并及時反饋給我們,我們會重新發(fā)貨;實驗的過程中,請嚴(yán)格按照說明書進(jìn)行操作,如遇技術(shù)問題可與我司技術(shù)部咨詢。
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關(guān)鍵字: Ethynyl estradiol;57-63-6;98.0%;