51276-34-7上海谷研科技有限公司對(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*,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)。
51276-34-7上海谷研科技有限公司相關(guān)優(yōu)質(zhì)產(chǎn)品信息:
1-METHOXYDECANE 甲癸醚 7289-52-3
1-Methoxypiperidin-4-one 1-甲氧基哌啶-4-酮 102170-24-1
1-Methyl-1,2,3,4-tetrahydroisoquinoline 1-甲基-1,2,3,4-四氫異喹啉 4965/9/7
1-Methyl-1,3-dihydro-iMidazol-2-one 39799-77-4
3-PyridinecarboxaMide,1,4-dihydro-1-Methyl-(9CI) 17750-23-1
1-METHYLCYCLOPROPANAMINE HYDROCHLORIDE 1-甲基環(huán)丙胺 22936-83-0
1-Methyl-1H-indazole-4-carbaldehyde 1053655-56-3
5-AMi-Methylpyrazole 1-甲基-5-氨基吡唑 1192-21-8
1-METHYL-2-IMIDAZOLIDINONE 1-甲基-2-咪唑啉酮 694-32-6
對(duì)照品或標(biāo)準(zhǔn)品混用,即將對(duì)照品或標(biāo)準(zhǔn)品用于不是其標(biāo)定方法的含量測(cè)定,是藥品檢驗(yàn)中經(jīng)常出現(xiàn)但未引起重視的一個(gè)問題[3]。盡管同一批對(duì)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(shí)差別會(huì)很大。如英國Glaxo公司提供的*酯對(duì)照品,HPLC標(biāo)定為96.9%,供含量測(cè)定用;UV為98.8%,供溶出度測(cè)定。雖然中國藥典凡例明確規(guī)定衛(wèi)生部所發(fā)對(duì)照品僅用于正文中所規(guī)定的分析方法。但由于:
?。?)衛(wèi)生部提供的對(duì)照品使用說明書不夠詳盡,大多無對(duì)照品質(zhì)量要求及標(biāo)定方法;
(2)對(duì)對(duì)照品或標(biāo)準(zhǔn)品的正確使用缺乏認(rèn)識(shí);
(3)日??蒲兄袠O難找到相應(yīng)的對(duì)照品;
?。?)中國藥典正文中也常存在對(duì)照品混用的問題,如常將含量測(cè)定用的標(biāo)準(zhǔn)品或?qū)φ掌酚糜谌艹龆葯z查,而含量測(cè)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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