2,6-二甲基苯胺作為基因毒性雜質(zhì)控制，它的每日最大攝入量是多少？（1.5μg/天做不到）目前找到一個(gè)雷諾嗪緩釋片在澳洲申報(bào)的資料中提到2,6-二甲基苯胺的每日最大攝入量范圍是20.4μg/天~110μg/天，有沒有哪位大神知道這兩個(gè)值的來源及推導(dǎo)過程，求助。原文如下：The sponsor also commissioned two nonclinical risk assessments on DMA relative to  potential exposure from ranolazine under the conditions of use. Both assessors referred to  methodologies advocated in the ICH guideline.21 The updated guideline permits the use of  compound-specific assessments (compared with. TTC-based acceptable intake of  1.5 μg/day) when sufficient carcinogenicity data exists, such that a compound-specific  acceptable intake can be extrapolated from measures of carcinogenic potency. Information  on the carcinogenicity of DMA is available from a 2 year dietary study in rats (NTP, 1990)  and is the only source of data on carcinogenic potency. The first nonclinical assessor referred to a follow-up report to the NTP report where  carcinogenic potential (TD50) was set at 20.4 mg/kg. By linear extrapolation the  acceptable lifetime daily intake was calculated as 0.41 μg/kg/day (24.5 μg/day for 60 kg  adult or 20.4 μg/day for 50 kg adult). The amount of DMA detected in 750 mg ranolazine  tablets after 24 months storage (1.6 μg/tablet or 3.2 μg/day based on average batch values  outlined above in Table 7) were at least 6.4 fold lower than the extrapolated acceptable  lifetime daily intake of 20.4 μg/day (for 50 kg adult at the MRHD). The assessor indicated  that this was an acceptable safety factor but recommended that the shelf life of Ranexa be  no more than 24 months to ensure ranolazine degradation was minimal. The second nonclinical assessor evaluated risk assessments conducted by other regulatory  bodies where acceptable daily levels of DMA ranged between 20.4 μg/day to 110 μg/day  (for 50 kg adult). The most conservative approach gave acceptable daily levels of  29 μg/day (20.4 μg/day for 50 kg adult) and was the same as that   [更多]

求購以下質(zhì)量標(biāo)準(zhǔn)：脂肪乳氨基酸（17）葡萄糖（11%）注射液（卡文）執(zhí)行質(zhì)量標(biāo)準(zhǔn)（YBH00952017）；脂肪乳氨基酸（17）葡萄糖（11%）注射液（卡文）注冊標(biāo)準(zhǔn)；脂肪乳（10%）氨基酸（15）葡萄糖（20%）注射液注冊標(biāo)準(zhǔn)；氨基酸葡萄糖注射液（克靈麥）注冊標(biāo)準(zhǔn)（需要除JX20040105外的其余最新標(biāo)準(zhǔn)）；氨基酸葡萄糖注射液（克靈麥）注冊標(biāo)準(zhǔn)。   [更多]

YBH00332021  或YBH02572020  或YBH00982021 或其他廠家過評標(biāo)準(zhǔn)提供一家即可   [更多]

求購吸入用布地奈德混懸液進(jìn)口注冊信息（JX20）一份   [更多]

（1）Furr BJA, Milsted RAy. Role of LU-RH analogues in cancer treatment. In: Stoll BA, (ed) Reviews on Enocrine Related cancer; No. 26, Macclesfield, UK: IC Pharmaceuticals, 1987; 5-11（2）Furr, BJA, Valcaccia B, Curry B, Woodburn JR. Chesterson C, Tucker H. ICI 176-334: A novel non-steroidal, peripherally selective antiandrogen. J Endocrinol 1987; 113:R7-R9（3）B J Furr, F G Hutchinson Biodegradable sustained release formulation of the LH-RH analogue \'Zoladex\' for the treatment of hormone-responsive tumours， Prog Clin Biol Res . 1985；185A:143-53. 鏈接：https://pubmed.ncbi.nlm.nih.gov/3162174/   [更多]

YBH00992021或YBH17382021   [更多]

需求：原研公司VIFOR的原料藥質(zhì)量信息   [更多]

要求： 本公司主要承接藥企的方法開發(fā)與驗(yàn)證項(xiàng)目工作，并有意發(fā)展為CRO實(shí)驗(yàn)室。 需要一整套體系文件（包括SOP及其記錄表格）越詳細(xì)越好，設(shè)備管理操作、偏差管理，OOS、CAPA等文件及其相應(yīng)記錄表格等等 注意：需要一臺完整的體系文件，不是單個(gè)文件！謝謝   [更多]

維生素D3粉質(zhì)量標(biāo)準(zhǔn),注意是粉   [更多]

用于學(xué)習(xí)的，求購更昔洛韋滴眼液質(zhì)量信息。   [更多]