当前位置：   首页 > 需求大厅

 >  生产研发 

 >  分析检测 

求购地夸磷索钠原料药质量信息（原研，清晰电子版）   [更多]

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]

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]

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]

YBH00992021或YBH17382021   [更多]

求购一份乙酰半胱氨酸颗粒2024年注册信息   [更多]

相关口溶膜的质量标准均可以。   [更多]

需要盐酸氨溴索制剂质量信息20140324   [更多]