50656-92-3上海谷研科技有限公司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*,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)。
50656-92-3上海谷研科技有限公司相關(guān)優(yōu)質(zhì)產(chǎn)品信息:
(2-AMINO-ETHYL)-UREA HCL 858001-69-1
[2-(aMinoMethyl)phenyl]Methanol 2-(氨基甲基)芐醇 4152-92-5
-(2-CARBOXY-2-CYANOVINYL)JULOLIDINE 142978-18-5
2-(chloroethyl)MethylaMine (2-CHLORO-ETHYL)-METHYL-AMINE 32315-92-7
(2E)-(6-Methoxy-2,3-dihydro-1H-inden-1-ylidene)ethanenitrile 187871-98-3
(2E)-3-(4-Chlorophenyl)acryloyl chloride 95602-71-4
(2E)-4-(DiMethylaMino)but-2-enoic acid 98548-82-4
(2E)-but-2-enedioic acid 24461-32-3
Methyl (E,E,Z)-2,4,6-Decatrienoate 51544-64-0
(2E,4Z,6E,8E)-3,7-diMethyl-9-(2,6,6-triMethyl-1-cyclohexenyl)nona-2,4,6,8-tetraen-1-ol 22737-96-8
(2-ETHYLHEXYL) PHOSPHATE 磷酸-2-乙基己酯 1070-03-7
對照品或標(biāo)準(zhǔn)品混用,即將對照品或標(biāo)準(zhǔn)品用于不是其標(biāo)定方法的含量測定,是藥品檢驗(yàn)中經(jīng)常出現(xiàn)但未引起重視的一個問題[3]。盡管同一批對照品不同標(biāo)定方法的含量有很好的相關(guān)性,但并不*相同,有時差別會很大。如英國Glaxo公司提供的*酯對照品,HPLC標(biāo)定為96.9%,供含量測定用;UV為98.8%,供溶出度測定。雖然中國藥典凡例明確規(guī)定衛(wèi)生部所發(fā)對照品僅用于正文中所規(guī)定的分析方法。但由于:
(1)衛(wèi)生部提供的對照品使用說明書不夠詳盡,大多無對照品質(zhì)量要求及標(biāo)定方法;
(2)對對照品或標(biāo)準(zhǔn)品的正確使用缺乏認(rèn)識;
?。?)日??蒲兄袠O難找到相應(yīng)的對照品;
(4)中國藥典正文中也常存在對照品混用的問題,如常將含量測定用的標(biāo)準(zhǔn)品或?qū)φ掌酚糜谌艹龆葯z查,而含量測定方法與溶出度分析方法又不同,故極易引起混用。
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