PerkinElmer

药物及辅料

Ensuring purity and assuring compliance

Production comes to a halt when impurities are identified above the threshold level and the drug substance must be re-evaluated, increasing cost of production and time to market.

Drug substance is the active pharmacological ingredient used in a finished pharmaceutical product and has a direct effect on both the treatment and prevention of disease. To ensure the purity, quality and safety of a drug substance, it is essential to perform analytical tests to identify if any impurities or adulterants exist.

Our advance analytical tools provide the data to mitigate compliance risk and guide your GMP standards compliance for the identification of incoming raw material testing, drug substance assay and excipient quality.

The suitability of drug substance for its intended use is defined by attributes such as identity, strength, and purity – which can be achieved by using instruments, consumables and services you can find from PerkinElmer.

Explore Our Solutions

耗材及配件

Your partnership with PerkinElmer doesn't stop when you purchase an instrument. We also have a complete line of consumables and accessories engineered to keep t ...

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Drug Substance Assay

Inspections of drug substances are designed to confirm manufacturing plants, as well as the quality control laboratory, follow CGMP regulations. An extensive se ...

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Cleaning Validation

Regulatory authorities expect pharmaceutical companies to have written standard operating procedures (SOPs) detailing the cleaning processes used for various pi ...

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Pharmaceutical Raw Material Identification

The analysis of all incoming pharmaceutical raw materials is a key part of GMP compliance to guarantee safety and efficacy of a finished dosage form which is la ...

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Excipients Characterization

The quality of excipients is extremely important since 90% of medicines are made up of them. When it comes to regulatory guidelines, there are several the indus ...

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Polymorphic Forms

During the process of manufacturing finished dosage forms (solids), an organic molecule can adopt more than one crystalline form which can have significant effe ...

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Explore Our Instruments

色谱

无论您要面对怎样的的应用、技术和法规要求,我们都有色谱解决方案来解决您的分离和检测难题。 我们的多元化产品组合包括液相色谱仪(LC),液相色谱/质谱联用仪(LC/MS),气相色谱仪(GC),气相色谱/质谱联用仪(GC/MS)和Arnel-GC工程色谱系统。此外,我们提供最全面的样品前处理技术解决方案,其中包括一系列的自 ...

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原子光谱

如果您正在寻找世界领先的AA,ICP-OES,ICP-MS或汞分析系统,您已经到了正确的地方。 全世界数以万计的用户依靠PerkinElmer光谱仪快速、高效、轻松地从无机元素分析中获得准确的结果。无论哪种领域、应用或样品类型,我们都有相应的工具和专业知识可提供帮助 - 所有这些都是基于50多年来在原子光谱领域累积的前 ...

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分子光谱

复杂材料表征技术,总有一款适合您。我们拥有全面的分析解决方案,可以为各种的实验室提供理想的分子光谱仪器,包括紫外光谱,红外光谱及荧光光谱。 更高精度,确保获得更高的灵敏度 灵活的设计,满足不同尺寸的样品测试 多种采样附件可供选择 更短的样品配置时间 软件易学易用,提供专业的结果 作为红外光谱技术的业界先驱,我们在60年 ...

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热分析

使用我们全面的热分析仪器系列,提高热分析的精确度,灵敏度和性能。我们业界领先技术的应用包括: QA/QC应用 药物过程研究 聚合物研究 回收塑料的识别 包装材料的测定 纳米材料 涂料 复合材料 其他更多 仅供科学研究,非临床诊断用途。

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