476-70-0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)。
476-70-0上海谷研科技有限公司相關(guān)優(yōu)質(zhì)產(chǎn)品信息:
[3-[3,4-bis(carboxyMethyl) phenyl]-1-hydroxy-1-oxopropan -2-yl]azaniuMchloride 37169-56-5
[3aS-(3aa,4a,5b,6aa)]-4-[[[(tert-Butyl)diMethylsilyl]oxy]Methyl]-5-[(tetrahydro-2H-pyran-2-yl)oxy]hexahydro-2(1H)-pentalenone [3AS-(3AA,4A,5B,6AA)]-4-[[[(叔丁基)二甲基硅]氧]甲基]-5-[(四氫-2H-吡喃-2-基)氧基]六氫-2(1H)-二并環(huán)戊二烯酮 112168-22-6
[3-Chloro-2-Methylphenyl] MethylcyanocarboniMidodithioate 152382-29-1
[4-(2,2':6',2''-Terpyridin-4'-yl)phenyl]Methanol 447399-94-2
[4-CHLORO-2-(TRIFLUOROMETHYL)PHENYL] METHYL CYANOCARBONIMIDODITHIOATE 152382-23-5
[5-(TrifluoroMethyl)-2-Furyl]Methanol [5-(三氟甲基)-2-呋喃]甲醇 65865-28-3
[5-[[4-[2-(5-Ethyl-2-pyridinyl)ethoxy]phenyl]Methyl]-2,4-] thiazolidinedione hydrochloride 5-{4-[2-(5-乙基-2-吡啶)-乙氧基]-苯基}-2,4-噻唑烷二酮鹽酸鹽 112529-15-4
[5-[2-[(tert-butyl)aMino]-1-hydroxyethyl]-2-hydroxyphenyl]uroniuM chloride 34866-46-1
[C84] PCBM 3'-苯基-3'H-環(huán)丙并[18,37][5,6]富勒烯-C84-D2D-3'-丁酸甲酯 905843-95-0
[ethoxy(phenylMethylsulfanyl)phosphoryl]benzene 21722-85-0
[trans(trans)]-4'-propyl[1,1'-bicyclohexyl]-4-carbonitrile 65355-35-3
6-BROMO ACETYL-2-DIMETHYLAMINONAPHTHALENE 6-溴乙?;?2-二甲氨基萘 210832-86-3
2-Propanone,1,1,3,3-tetrafluoro- 360-52-1
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(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;
?。?)對(duì)對(duì)照品或標(biāo)準(zhǔn)品的正確使用缺乏認(rèn)識(shí);
?。?)日常科研中極難找到相應(yīng)的對(duì)照品;
(4)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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