
起始物料,原始材料;原材料
When you're developing a new chemical process or API process you should be discussing your choice of API starting material with the review division.
当你开发一条新的化学工艺或是API生产工艺的时候,你最好和药政审核部门讨论你的起始物料选择。
An API starting material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house.
原料药的起始物料可能是在市场上有售、能够通过合同或商业协议从一个或多个供货商处购得,或由生产厂家自制。
An Active Substance Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house.
原料药起始物料可以是一市售产品,或是根据合同或商业协议从一个或多个供应商处购买的物料,也可以是内部生产。
The Kyoto University researchers hope to be able to repeat their success using sliversof skin as starting material, allowing men to father children that are genetically their own.
日本京都大学的研究者们希望可以复制他们的成功经验,以皮肤组织为原始材料,让男性拥有自己的亲生孩子。
If a proposed starting material does not meet all of the general principles, a rationale should be provided explaining why the starting material is considered appropriate.
如果所拟的起始物料不符合所有的通则,则应该给出合理解释说明为什么该起始物料是合适的。
Appropriate qualification of API Starting Material suppliers is required.
起始物料的供应商应具备适当的资质。
Q. How do you define a significant structural element in an API starting material?
问:请问如何定义API起始物料中的“重要(有效)结构单元”?
This GMP guidance does not apply to steps prior to the introduction of the defined API starting material.
本GMP指南不适用于引入定义了的“原料药的起始物料”以前的步骤。
The certificate of analysis of the manufacturer/supplier of the starting material should be signed by a designated person with appropriate qualifications and experience.
起始物料的生产商/供应商检验报告应有负责人签名,其应具备适当的资质和经验。
This GMP Guide does not apply to steps prior to the introduction of the defined API Starting Material.
本GMP指南并不适用于确定的“API起始物料”引入前的步骤。
It can be use as an environment-friendly intermediate and starting material for organic synthesis substituting the poisonous phosgene and dimethyl sulfate in carbonylation and methylation reaction.
它可以代替剧毒的光气和***************作为环境友好的有机合成中间体和起始物质,应用与羰基化和甲基化反应中。
A tremendous amount of work has been done on the purification of the starting material .
人们在提纯原始材料方面做了大量的工作。
With such diverse and abundant starting material, the researchers were able to sketch a picture of ethnicity far more detailed than previously known.
有了这些丰富多样的研究材料,科研人员可以勾画出比现在已知的更为细节化的种族图谱。
The finished chain then hangs around without reacting while more of the starting material reacts to form new polymer chains.
当不再反应时,链的增长停止,同时新的反应开始,生成新的聚合物链。
Screening for 2 - bromo-butyric acid as the starting material, after ammonolysis, esterification, ester amine solution, split, five-step cyclization reaction Levetiracetam.
筛选以2-溴代丁酸为起始原料,经氨解,酯化,酯胺解,拆分,环合五步反应制得左乙拉西坦。
Solvent for perfume pharmaceutical preparations coloring matter Antifreeze in automobile Starting material for various synthesis .
用作香料医药制剂色素的溶剂汽车防冻液等也是各种化工合成之原料。
Methods:Zileuton wassynthesized via 3-step reactions with 2-acetyl benzothiophene as the starting material.
方法:以2-乙酰基苯并噻吩为起始原料,经3步反应合成齐留通。
For novel amino acid type amphoterics, primary amine can be the starting material and other atoms or groups were introduced during the reaction.
氨基酸型两性表面活性剂以伯胺为原料,合成出分子中引入了其他原子或基团。
With cheap butyl diacid and chloroacetic acid as starting material, butane-tetracarboxylic acid (BTCA) was synthesized through rational synthesis route.
采用廉价的丁二酸和*********为起始原料,选择合理的合成路线,合成了BTCA。
Branched glycidyl azide polymer(B GAP) was prepared from industrial polyepichlorohydrin(PECH) rubber as a starting material after reaction with sodium azide.
以工业氯醇橡胶为原料,通过与************反应制备出支化聚叠氮缩水甘油醚(BGAP)。
The starting material for producing API from which country?
生产API的起始原料来自那个国家?
Industrially, ammonia is the starting material for most other nitrogen compounds (especially nitrates and nitrites), whose main uses are in agricultural fertilizers and explosives.
氨是其它氮化合物(尤其是硝酸盐和亚硝酸盐)的起始物质,这些化合物主要用于农业肥料和炸药。
Valacyclovir hydrochloride was synthesized from acyclovir as starting material, by condensation and hydrogenising in 85% overall yield.
以阿昔洛韦为起始原料,经缩合、氢化制得盐酸万乃洛韦,总收率85%。
METHOD:p Fluorobenzylamine, which is the intermediate compound of some medicine, was synthesized by 3 steps with p Nitrobenzoic acid as starting material.
方法:以对*********甲酸为原料经氟化、酰化和还原3步合成药物中间体对氟苄胺。
What constitutes the starting material may not always be obvious.
什么构成了“起始物料”并不总是很明显。
Naphthenic acid alkanolamide was synthesized as flooding agent with petroleum naphthenic acid as starting material.
以石油环烷酸为原料制备出石油环烷酸烷醇酰胺类驱油用表面活性剂。
|original material;起始物料,原始材料;原材料
在化学与制药领域,“starting material”(起始物料)是指用于合成目标产物或活性药物成分(API)的原始化学物质或化合物。它是整个生产流程的起点,直接影响最终产品的质量与安全性。例如,在阿司匹林合成中,水杨酸和乙酸酐通常被定义为起始物料。
这一概念在药品监管中尤为重要。根据国际人用药品注册技术协调会(ICH)的规定,起始物料需满足明确的化学特性与纯度标准,且其选择需确保后续反应步骤能有效控制杂质生成。美国FDA在《药品生产质量管理规范》(cGMP)中同样要求企业建立起始物料的完整溯源体系。
在材料科学领域,起始物料可能包括金属氧化物、聚合物单体等基础成分。例如钛酸钡陶瓷的制备常以碳酸钡和二氧化钛为起始物料。学术界普遍通过傅里叶变换红外光谱(FTIR)和高效液相色谱(HPLC)等技术对起始物料进行表征分析。
"Starting Material"(起始物料)是化学、制药及工业生产中的常用术语,其核心含义和具体应用如下:
如需进一步了解具体行业的应用规范,可参考制药领域的ICH Q7 指南或相关生产标准文件。
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