Impurity Testing and Quantification

During drug development and manufacturing, impurities are far from insignificant "minor issues." They are critical factors affecting drug purity, stability, safety, and ultimately, successful market launch. Detection and quantification of drug impurities are crucial to ensuring drug purity, safety, and quality.

Protheragen Impurity is dedicated to providing comprehensive drug impurity solutions. We deeply understand the critical importance of impurity studies in drug development and manufacturing. We offer integrated impurity testing and quantification services to help you precisely detect, quantify, and effectively control impurities in your drugs, ensuring their safety. If you are struggling to precisely detect trace impurities in your drugs, contact us today to receive your customized solution and quote.

Our Services

Impurities in drugs include organic impurities, inorganic impurities, or residual solvents. These impurities are typically present at very low or trace levels within complex sample matrices. Consequently, their detection and quantification require highly sensitive and specific methods.

As a leader in impurity research, Protheragen Impurity is equipped with state-of-the-art laboratory instrumentation. This enables us to overcome the challenges associated with low detection levels and precisely detect and quantify impurities in both active pharmaceutical ingredients (APIs) and final dosage form.

Impurity Testing

Impurity testing utilizes advanced analytical techniques to comprehensively "capture" any potential impurities present in the drug's active pharmaceutical ingredient (API) or final dosage form. This includes both known and unknown impurities, organic and inorganic impurities, as well as volatile and non-volatile impurities.

Impurity Identification and Structure Elucidation

This involves performing an unambiguous "identification" of detected unknown impurities or known impurities exceeding identification thresholds to elucidate their precise chemical structure.

Impurity Quantification

Once the identity of an impurity is determined, conducting high-precision, high-sensitivity quantification of its content is paramount. This directly determines whether impurity levels fall within established safety thresholds and is critical for both drug safety and successful regulatory submission.

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