Ensuring that pharmaceutical products are free from harmful levels of residual solvents and heavy metals is a critical aspect of patient safety and regulatory compliance. At Abiozen, we implement advanced analytical technologies to detect and quantify these impurities with exceptional accuracy, aligning with global health authority standards.

Detection and Quantification of Class 1, 2, and 3 Solvents

Residual solvents are classified by toxicity levels according to ICH Q3C guidelines. At Abiozen, we employ gas chromatography with flame ionization detection (GC-FID) and headspace sampling techniques to precisely quantify the presence of Class 1 (most toxic), Class 2, and Class 3 solvents. This ensures all solvent levels fall well within the acceptable thresholds for human exposure, safeguarding product safety.

Heavy Metal Analysis Using ICP-MS

To identify trace levels of toxic metals such as lead, mercury, and arsenic, we utilize state-of-the-art inductively coupled plasma mass spectrometry (ICP-MS). Our systems provide detection at parts-per-billion (ppb) sensitivity and are fully compliant with USP <232> and ICH Q3D guidelines. This capability ensures rigorous control over elemental impurities, especially in formulations for chronic or injectable use.

Industry Alignment

Our analytical strategy is modeled on Thermo Fisher CRDMO’s industry-leading ICP-MS systems and Curia Global’s excellence in residual solvent analysis for complex APIs. Abiozen’s adherence to these high standards enables us to deliver reliable, compliant, and globally accepted impurity testing data for every product we analyze.