EDQM標(biāo)準(zhǔn)物質(zhì)是經(jīng)過專門篩選的,并由歐洲藥典委員會(huì)對(duì)檢驗(yàn)后的標(biāo)準(zhǔn)物質(zhì)進(jìn)行確認(rèn)。根據(jù)標(biāo)準(zhǔn)物質(zhì)的用途(如鑒別、純度檢查、含量測(cè)定),可能會(huì)作為國(guó)際協(xié)作研究的項(xiàng)目。根據(jù)ISO導(dǎo)則34基本原則建立與分發(fā)標(biāo)準(zhǔn)物質(zhì)。這些標(biāo)準(zhǔn)物質(zhì)可在鑒別試驗(yàn)、有關(guān)物質(zhì)檢查、含量測(cè)定等藥物分析中用作對(duì)照品,也可用于儀器的校正。
EDQM被指定為WHO抗生素國(guó)際標(biāo)準(zhǔn)品的協(xié)作標(biāo)定中心
在WHO生物制品標(biāo)準(zhǔn)化專家委員會(huì)第56次會(huì)議上,EDQM被指定為WHO抗生素國(guó)際標(biāo)準(zhǔn)品(ISA)協(xié)作標(biāo)定與分發(fā)中心。EDQM負(fù)責(zé)抗生素國(guó)際標(biāo)準(zhǔn)品的制備、貯藏與分發(fā)。WHO抗生素國(guó)際標(biāo)準(zhǔn)品通常是用于建立實(shí)驗(yàn)室日常用于檢查和含量測(cè)定的地區(qū)或國(guó)家二級(jí)標(biāo)準(zhǔn)品。
Y0000029 Azaperone 50 mg
A1500000 Azathioprine 100 mg
Y0000326 Azelastine hydrochloride 25 mg
Y0000327 Azelastine impurity B 5 mg
Y0000328 Azelastine impurity D 5 mg
Y0000329 Azelastine impurity E 5 mg
Y0000306 Azithromycin 200 mg
Y0000637 Azithromycin for peak identification 15 mg
Y0000641 Azithromycin for system suitability 0.05 mg
Y0000307 Azithromycin impurity A 10 mg
Y0000308 Azithromycin impurity B 0.04 mg
Y0000285 B19 virus DNA for NAT testing BRP 150 mg
B0070000 Bacampicillin hydrochloride 120 mg
B0100000 Bacitracin zinc 150 mg
B0200000 Baclofen 50 mg
B0200050 Baclofen impurity A 50 mg
B0250000 Bambuterol hydrochloride 100 mg
B0300000 Barbital - * psy 500 mg
Y0000295 Basic butylated methacrylate copolymer-reference spectrum n/a
B0305000 Beclometasone dipropionate anhydrous 150 mg
Y0000351 Beclometasone dipropionate monohydrate 10 mg
Y0000352 Beclometasone dipropionate for system suitability 10 mg
Y0000469 Beclometasone dipropionate for peak identification 10 mg
B0400000 Bendroflumethiazide 100 mg
Y0000564 Bendroflumethiazide impurity A 5 mg
Y0000044 Benfluorex hydrochloride 50 mg
Y0000043 Benfluorex hydrochloride for system suitability 360 mg
B0470000 Benperidol 100 mg
B0477000 Benserazide hydrochloride 50 mg
B0477010 Benserazide impurity A 20 mg
B0490000 Benzarone 10 mg
詳情請(qǐng)登錄北京綠百草網(wǎng)站:www.greenherbs.com.cn,TEL:010-51659766
歐洲藥典標(biāo)準(zhǔn)品Y0000326-北京綠百草提供