Residual solvents in pharmaceutical products are organic volatile compounds used or produced in the manufacturing of drug substances or excipients, in the preparation of drug products or from packaging and storage. The USP <467> classifies solvents by their toxicity levels and potential adverse effects. To help you ensure the safety and quality of your pharmaceutical product, we provide robust testing for various classes of solvents.
Our analysts possess more than two decades of experience analyzing pharmaceutical products for residual solvents and can test products at any stage of development (raw materials, intermediate products and final products). We offer multiple gas chromatography instruments with headspace capabilities for the challenge of residual solvents testing.
Our testing capabilities cover screening, confirmation, identification and quantification of multiple classes of solvents:
- Class 1 solvents (known to cause unacceptable toxicities or to have environmental effects) must be avoided in the manufacturing process of drug substances, excipients or pharmaceutical products unless their use can be justified in a risk-benefit assessment.
- Class 2 solvents (associated with less severe toxicity) must be limited in order to protect patients from potential adverse effects.
- Class 3 solvents (less toxic), which pose a lower risk to human health, are allowed where practical. Residual solvents concentration of 50 mg per day or less, corresponding to 5000 ppm, is acceptable without justification.
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