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雜質控製

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.

爱游戏平台注册登录 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 爱游戏平台注册登录 .

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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 爱游戏平台注册登录 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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雜質分析

確保符合USP <232>/<233>和ICH Q3D要求(該標準製藥監管政策有史以來最重大的修訂)。 我們提供從樣品製備、儀器檢測的完整解決方案,確保完全符合USP <232> / <233>和ICH Q3D中的相關規定。

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色譜

無論您要麵對怎樣的的應用、技術和法規要求,我們都有色譜解決方案來解決您的分離和檢測難題。 我們的多元化產品組合包括液相色譜儀(LC),液相色譜/質譜聯用儀(LC/MS),氣相色譜儀(GC),氣相色譜/質譜聯用儀(GC/MS)和Arnel-GC工程色譜係統。此外,我們提供最全麵的樣品前處理技術解決方案,其中包括一係列的自 ...

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原子光譜

如果您正在尋找世界領先的AA,ICP-OES,ICP-MS或汞分析係統,您已經到了正確的地方。 全世界數以萬計的用戶依靠爱游戏平台注册登录 光譜儀快速、高效、輕鬆地從無機元素分析中獲得準確的結果。無論哪種領域、應用或樣品類型,我們都有相應的工具和專業知識可提供幫助 - 所有這些都是基於50多年來在原子光譜領域累積的前 ...

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分子光譜

複雜材料表征技術,總有一款適合您。我們擁有全麵的分析解決方案,可以為各種的實驗室提供理想的分子光譜儀器,包括紫外光譜,紅外光譜及熒光光譜。 更高精度,確保獲得更高的靈敏度 靈活的設計,滿足不同尺寸的樣品測試 多種采樣附件可供選擇 更短的樣品配置時間 軟件易學易用,提供專業的結果 作為紅外光譜技術的業界先驅,我們在60年 ...

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熱分析

使用我們全麵的熱分析儀器係列,提高熱分析的精確度,靈敏度和性能。我們業界領先技術的應用包括: QA/QC應用 藥物過程研究 聚合物研究 回收塑料的識別 包裝材料的測定 納米材料 塗料 複合材料 其他更多 僅供科學研究,非臨床診斷用途。

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