Non-Volatile Organic Impurities

Identify and quantify organic impurities in drug substances and drug products

Impurity profiling is a critical quality control step in the production of pharmceaticals and biopharmaceuticals. This process is careful regulated by bodies such as ICH & US FDA. ICH guidelines for impurities states that each impurity must be investigated with respect to both pysicochemical and safety aspects. Structural characterization, quantification and reporting must be performed using suitable analytical procedures.

Confident, unambiguous elemental composition and substructural information can be provided by our Orbitrap-based mass spectrometry systems, together with advanced informatics capabilities and libraries.

Non-volatile organic impurity profiling workflow

Non-volatile organic impurities workflow

Non-volatile organic impurity profiling categories
See everything with near-universal CAD detectors

強化された直線性ダイナミックレンジおよび正確で一貫した応答を備えたこの検出器は、低濃度の不純物と医薬品有効成分 (API) を同時測定できるほか、化学構造に関係なく他の化合物も測定できます。

Advanced software for identification of unknowns

This software ensures confident, unambiguous compound identification and structural elucidation for pharmaceutical impurity studies. Compound Discoverer software helps researchers plan how data will be collected, organized, stored, and reported with the final result in mind. ノード組立式のデータ処理ワークフロー、高度な解析アルゴリズム、および研究目的に応じたデータ保存法により、ユーザーは複数のサンプルから収集したデータを迅速に処理し、単一レポートを作成することができます。

Mass spectrometry for absolute confidence in unknown identification

The Q Exactive™ Plus Hybrid Quadrupole-Orbitrap™ Mass Spectrometer takes impurity profiling to the next level with increased performance and new options that enhance screening studies.