Residual Solvents

Turning Residual Solvent Challenges into Quality and Safety

Residual solvents—chemical residues left behind from manufacturing, purification, or packaging—can compromise product safety, stability, and compliance. At Quantum Analytics Group, we provide accurate residual solvent testing in alignment with USP <467>, ICH Q3C, and global pharmacopeial standards to safeguard your products and your brand. Our capabilities include Gas Chromatography–Headspace (GC-HS) for Class 1, 2, and selected Class 3 solvents, GC–MS–Headspace (GC-MS-HS) for confirmation and identification of unknowns, and Ion Chromatography (IC) for Class 3 solvents not amenable to GC.

We offer compendial testing, custom protocol development for unique matrices, and cost-efficient self-validating approaches designed for infrequent analyses. With proven expertise and advanced instrumentation, Quantum delivers defensible data that ensures regulatory confidence, patient and consumer safety, and uncompromised product quality—because when accuracy matters, you can trust Quantum Analytics Group.

Protecting Products with Residual Solvent Testing

Review specifications and requirements
Gather product details, regulatory guidelines, and any batch history for the materials in question.

Select Analytical Testing Methods
Apply validated techniques such as GC and GC-HS to detect and quantify residual solvents with precision.

Perform Targeted Analysis
Measure solvent levels against established safety and compliance thresholds.

Provide Actionable Results
Deliver a complete, compliance-ready report with findings and any corrective recommendations

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Regulatory Compliance Verification
Confirm that solvent levels meet USP, ICH, or region-specific guidelines.

Quality Control for Manufacturing
Monitor residual solvent levels throughout production to ensure consistent quality.

Investigation of Failed Batches
Identify the cause of solvent-related quality issues to prevent recurrence.

 


 

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