Providing high value-added API and pharmaceutical intermediates.
为客户提供高质量、高标准、高附加值的医药原料药和中间体。
The combination of controls, calibration, and, where appropriate, equipment qualification assures API quality during this development phase.
控制、校验和必要的设备确认的结合会保证开发阶段的原料药质量。
Take your design to a new realm and learn how others implemented the API.
Hyperstone's API software allows engineers to innovate and design unique storage solutions by developing individual firmware extensions.
海派世通的应用程序接口软件使工程师通过开发个人固件扩展来创新和设计独特的存储解决方案。
Limits can be established based on the minimum known pharmacological, toxicological, or physiological activity of the API or its most deleterious component.
可以根据原料药或其最有害的组分的已知最小药理、毒理或生理活性浓度来制定限度。
So far you must already have a customer interested in your API.
至今为止,你必须已有一个对你原料药感兴趣的客户。
Identifying process parameters that could affect the critical quality attributes of the API
确认可能对原料药关键质量属性有影响的工艺参数;
The impurity profile is normally dependent upon the production process and origin of the API.
杂质概况一般与原料药的生产工艺和起源有关。
The final decision regarding rejected raw materials, intermediates or API labelling and packaging materials.
拒收原料、中间体或原料药的标签和包装材料的最终决定。
Use or disposal of the returned intermediate or API
退回中间体或原料药的使用或处置意见。
Impurity profiles have been established for the existing API
现有原料药的杂质概况已确定。
Description of packaging and label for intermediate or API
中间体或原料药的包装和贴签操作的详细描述;
Approving changes that potentially affect intermediate or API quality
批准可能影响到中间体或原料药质量的变更;