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2,6-二甲基苯胺作为基因毒性杂质控制，它的每日最大摄入量是多少？（1.5μg/天做不到）目前找到一个雷诺嗪缓释片在澳洲申报的资料中提到2,6-二甲基苯胺的每日最大摄入量范围是20.4μg/天~110μg/天，有没有哪位大神知道这两个值的来源及推导过程，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]

注册信息JX20150308   [更多]

求购以下质量标准：脂肪乳氨基酸（17）葡萄糖（11%）注射液（卡文）执行质量标准（YBH00952017）；脂肪乳氨基酸（17）葡萄糖（11%）注射液（卡文）注册标准；脂肪乳（10%）氨基酸（15）葡萄糖（20%）注射液注册标准；氨基酸葡萄糖注射液（克灵麦）注册标准（需要除JX20040105外的其余最新标准）；氨基酸葡萄糖注射液（克灵麦）注册标准。   [更多]

YBH00332021  或YBH02572020  或YBH00982021 或其他厂家过评标准提供一家即可   [更多]

需要药物警戒质量管理规范要求下全套药物警戒文件和记录   [更多]

求购吸入用布地奈德混悬液进口注册信息（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. 链接：https://pubmed.ncbi.nlm.nih.gov/3162174/   [更多]

机构和人员：质量手册和程序文件，人员培训管理文件，消毒剂管理文件，人员健康档案文件等； 厂房与设施：工艺用气管理文件及验证文件，车间空气净化系统验证文件； 设备：生产设备验证文件，生产设备清洁验证文件，生产设备操作规程，检验设备操作规程； 设计开发：相关文件及记录 生产管理：工艺卫生管理文件，生产管理文件，批记录文件，生产工艺规程文件，清场管理文件，灭菌工艺验证文件，批号管理文件等； 质量控制：工艺用水管理文件，工艺用水验证文件，初始污染菌和微粒污染控制水平的文件规定，产品检验规程，原材料检验规程，外包材检验规程，留样管理文件等 采购：相关采购文件和记录 销售：相关销售管理制度及记录   [更多]

求购阿莫西林克拉维酸钾片工艺，规格0.625g。   [更多]

我司计划以MAH委托CMO方式，进行数个固体制剂项目的申报与注册申报后的委托生产，现询川渝两地的GMP车间进行项目合作： 要求：1. 有较为完善的GMP质量体系并通过新版GMP认证，并有意进行化药固体制剂CMO合作； 2. 化药固体制剂车间，配备流化床（制粒用）、混合机、压片机、包衣机等设备及相应的技术与生产操作人员； 3. 公司有一定的产品研发注册经验； 4. 成都周边药企优先。 5. 需要提供受托方主要负责人的职位及手机号，必须保证信息的真实性和可靠性，电话沟通验证真实性后给予报酬。   [更多]