
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.
當你開發一條新的化學工藝或是API生産工藝的時候,你最好和藥政審核部門讨論你的起始物料選擇。
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.
原料藥的起始物料可能是在市場上有售、能夠通過合同或商業協議從一個或多個供貨商處購得,或由生産廠家自制。
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.
原料藥起始物料可以是一市售産品,或是根據合同或商業協議從一個或多個供應商處購買的物料,也可以是内部生産。
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.
日本京都大學的研究者們希望可以複制他們的成功經驗,以皮膚組織為原始材料,讓男性擁有自己的親生孩子。
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則,則應該給出合理解釋說明為什麼該起始物料是合適的。
Appropriate qualification of API Starting Material suppliers is required.
起始物料的供應商應具備適當的資質。
Q. How do you define a significant structural element in an API starting material?
問:請問如何定義API起始物料中的“重要(有效)結構單元”?
This GMP guidance does not apply to steps prior to the introduction of the defined API starting material.
本GMP指南不適用于引入定義了的“原料藥的起始物料”以前的步驟。
The certificate of analysis of the manufacturer/supplier of the starting material should be signed by a designated person with appropriate qualifications and experience.
起始物料的生産商/供應商檢驗報告應有負責人簽名,其應具備適當的資質和經驗。
This GMP Guide does not apply to steps prior to the introduction of the defined API Starting Material.
本GMP指南并不適用于确定的“API起始物料”引入前的步驟。
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.
它可以代替劇毒的光氣和***************作為環境友好的有機合成中間體和起始物質,應用與羰基化和甲基化反應中。
A tremendous amount of work has been done on the purification of the starting material .
人們在提純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.
有了這些豐富多樣的研究材料,科研人員可以勾畫出比現在已知的更為細節化的種族圖譜。
The finished chain then hangs around without reacting while more of the starting material reacts to form new polymer chains.
當不再反應時,鍊的增長停止,同時新的反應開始,生成新的聚合物鍊。
Screening for 2 - bromo-butyric acid as the starting material, after ammonolysis, esterification, ester amine solution, split, five-step cyclization reaction Levetiracetam.
篩選以2-溴代丁酸為起始原料,經氨解,酯化,酯胺解,拆分,環合五步反應制得左乙拉西坦。
Solvent for perfume pharmaceutical preparations coloring matter Antifreeze in automobile Starting material for various synthesis .
用作香料醫藥制劑色素的溶劑汽車防凍液等也是各種化工合成之原料。
Methods:Zileuton wassynthesized via 3-step reactions with 2-acetyl benzothiophene as the starting material.
方法:以2-乙酰基苯并噻吩為起始原料,經3步反應合成齊留通。
For novel amino acid type amphoterics, primary amine can be the starting material and other atoms or groups were introduced during the reaction.
氨基酸型兩性表面活性劑以伯胺為原料,合成出分子中引入了其他原子或基團。
With cheap butyl diacid and chloroacetic acid as starting material, butane-tetracarboxylic acid (BTCA) was synthesized through rational synthesis route.
采用廉價的丁二酸和*********為起始原料,選擇合理的合成路線,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.
以工業氯醇橡膠為原料,通過與************反應制備出支化聚疊氮縮水甘油醚(BGAP)。
The starting material for producing API from which country?
生産API的起始原料來自那個國家?
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(尤其是硝酸鹽和亞硝酸鹽)的起始物質,這些化合物主要用于農業肥料和炸藥。
Valacyclovir hydrochloride was synthesized from acyclovir as starting material, by condensation and hydrogenising in 85% overall yield.
以阿昔洛韋為起始原料,經縮合、氫化制得鹽酸萬乃洛韋,總收率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:以對*********甲酸為原料經氟化、酰化和還原3步合成藥物中間體對氟苄胺。
What constitutes the starting material may not always be obvious.
什麼構成了“起始物料”并不總是很明顯。
Naphthenic acid alkanolamide was synthesized as flooding agent with petroleum naphthenic acid as starting material.
以石油環烷酸為原料制備出石油環烷酸烷醇酰胺類驅油用表面活性劑。
|original material;起始物料,原始材料;原材料
在化學與制藥領域,“starting material”(起始物料)是指用于合成目标産物或活性藥物成分(API)的原始化學物質或化合物。它是整個生産流程的起點,直接影響最終産品的質量與安全性。例如,在阿司匹林合成中,水楊酸和乙酸酐通常被定義為起始物料。
這一概念在藥品監管中尤為重要。根據國際人用藥品注冊技術協調會(ICH)的規定,起始物料需滿足明确的化學特性與純度标準,且其選擇需确保後續反應步驟能有效控制雜質生成。美國FDA在《藥品生産質量管理規範》(cGMP)中同樣要求企業建立起始物料的完整溯源體系。
在材料科學領域,起始物料可能包括金屬氧化物、聚合物單體等基礎成分。例如钛酸鋇陶瓷的制備常以碳酸鋇和二氧化钛為起始物料。學術界普遍通過傅裡葉變換紅外光譜(FTIR)和高效液相色譜(HPLC)等技術對起始物料進行表征分析。
"Starting Material"(起始物料)是化學、制藥及工業生産中的常用術語,其核心含義和具體應用如下:
如需進一步了解具體行業的應用規範,可參考制藥領域的ICH Q7 指南或相關生産标準文件。
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