杂质控制 | PerkinElmer
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杂质控制

Regulatory bodies, such as the EMA and FDA, provide increasingly stringent guidelines around impurity limits, control of those impurities becomes exponentially critical in a Pharma QA/QC laboratory. Implementing testing to control impurities is crucial on your path to compliance.

PerkinElmer provides the tools and processes you need to take control of impurities testing for both drug substances and drug products –  providing the best technology for the identification and quantification of elemental impurities and the accurate measurement of residual solvents in accordance with strict regulatory guidelines.

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

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Organic Impurities

Pharmaceutical laboratories summarise actual and potential impurities that are most likely to arise during the synthesis, purification, and storage of the drug ...

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Extractables & Leachables

Pharmaceutical laboratories must evaluate the interactions between packaging material and formulation, applying risk assessments defined on ICH Q9 guidelines to ...

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Degradation Products

Drug manufacturers may be required to accelerate or force degradation of a product to demonstrate that it has gone through the stability indicating method. In s ...

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Residual Solvents

The synthesis of active pharmaceutical ingredients (API) may require multiple reaction steps that produce undesirable reaction byproducts or utilize various sol ...

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Foreign Particle Material Identification

Foreign Particle Material Identification is a key step in the quality control of medicines and is used to identify contaminants in drug products which might aff ...

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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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杂质分析

确保符合USP <232>/<233>和ICH Q3D要求(该标准制药监管政策有史以来最重大的修订)。 我们提供从样品制备、仪器检测的完整解决方案,确保完全符合USP <232> / <233>和ICH Q3D中的相关规定。

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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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