| 1. | The starting material for producing api from which country
生产原料（ api ）使用的起始物料来自哪个国家？ |
| 2. | Api starting materials normally have defined chemical properties and structure
原料药的起始物料一般来说有特定的化学特性和结构。 |
| 3. | 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” ？ |
| 4. | A ) transport , handling and use of starting materials , packaging ma ? terials , and bulk and ? nished products
起始物料的运输、处理和使用，物料、成品的包装， |
| 5. | Table 1 gives guidance on the point at which the api starting material is normally introduced into the process
表1给出了原料药的起始物料从哪一点引入工艺过程的指导原则。 |
| 6. | For synthetic processes , this is known as the point at which api starting materials are entered into the process
对于合成工艺而言，就是“原料药的起始物料”进入工艺的那一点。 |
| 7. | Q . how early should a company discuss with fda the company strategy , rationale and what we consider to be an api starting material for filing
问：什么时候公司必须和fda讨论公司对api起始物料选择的战略，理由和因素？ |
| 8. | 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应商处购得，或由生产厂家自制。 |
| 9. | An api starting material is a raw material , an intermediate , or an api that is used in the production of an api and that is incorporated as a significant structural fragment into the structure of the api
译文= “原料药的起始物料”是指一种原料、中间体或原料药，用来生产一种原料药，或者以主要结构单元的形式被结合进原料药结构中。 |
