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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）目前找到一個雷諾嗪緩釋片在澳洲申報的資料中提到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值的來源及推導過程，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]

注冊信息JX20150308   [更多]

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

YBH00332021  或YBH02572020  或YBH00982021 或其他廠家過評標準提供一家即可   [更多]

需要藥物警戒質(zhì)量管理規(guī)范要求下全套藥物警戒文件和記錄   [更多]

求購吸入用布地奈德混懸液進口注冊信息（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]

機構和人員：質(zhì)量手冊和程序文件，人員培訓管理文件，消毒劑管理文件，人員健康檔案文件等； 廠房與設施：工藝用氣管理文件及驗證文件，車間空氣凈化系統(tǒng)驗證文件； 設備：生產(chǎn)設備驗證文件，生產(chǎn)設備清潔驗證文件，生產(chǎn)設備操作規(guī)程，檢驗設備操作規(guī)程； 設計開發(fā)：相關文件及記錄 生產(chǎn)管理：工藝衛(wèi)生管理文件，生產(chǎn)管理文件，批記錄文件，生產(chǎn)工藝規(guī)程文件，清場管理文件，滅菌工藝驗證文件，批號管理文件等； 質(zhì)量控制：工藝用水管理文件，工藝用水驗證文件，初始污染菌和微粒污染控制水平的文件規(guī)定，產(chǎn)品檢驗規(guī)程，原材料檢驗規(guī)程，外包材檢驗規(guī)程，留樣管理文件等 采購：相關采購文件和記錄 銷售：相關銷售管理制度及記錄   [更多]

求購阿莫西林克拉維酸鉀片工藝，規(guī)格0.625g。   [更多]

我司計劃以MAH委托CMO方式，進行數(shù)個固體制劑項目的申報與注冊申報后的委托生產(chǎn)，現(xiàn)詢川渝兩地的GMP車間進行項目合作： 要求：1. 有較為完善的GMP質(zhì)量體系并通過新版GMP認證，并有意進行化藥固體制劑CMO合作； 2. 化藥固體制劑車間，配備流化床（制粒用）、混合機、壓片機、包衣機等設備及相應的技術與生產(chǎn)操作人員； 3. 公司有一定的產(chǎn)品研發(fā)注冊經(jīng)驗； 4. 成都周邊藥企優(yōu)先。 5. 需要提供受托方主要負責人的職位及手機號，必須保證信息的真實性和可靠性，電話溝通驗證真實性后給予報酬。   [更多]