Residual Solvent Test

Residual solvents in products commonly originate from raw materials, excipients, or the preparation process and are classified into three categories based on toxicity:

• Class 1: Solvents to avoid, which are human carcinogens, suspected carcinogens, or environmental hazards.
• Class 2: Solvents to limit, which are animal carcinogens or potential causes of irreversible toxicity like neurotoxicity or teratogenicity.
• Class 3: Solvents with low toxic potential. For example, substances like Acetic acid, Heptane, Acetone, Isobutyl acetate, Anisole, Isopropyl acetate, 1-butanol, Methyl acetate, and so on fall into Class 3 residual solvents, with permissible daily exposures (PDEs) of 50 mg or more per day.

Services Process

Sample collection&preparation&initial analysis

Upon receiving the samples, our laboratory professionals handle and prepare them for analysis to ensure that even trace amounts of residual solvents can be detected effectively.

Meanwhile, we initiate a comprehensive assessment that includes specific inquiries about the sample. This process helps us gather critical information, such as the potential presence of specific solvents within the sample matrix.

For example in many analytical techniques, methanol is commonly used as the sample solvent for injection. However, there are instances where methanol itself is one of the target analytes present in the sample. In such cases, we exercise flexibility by selecting alternative solvents for injection.

Providing this information in advance greatly expedites the analytical process, ensuring that the chosen solvent is compatible with the sample's characteristics and saving time. It helps us provide the right analysis strategy for accurate detection and ensuring minimal interference from background solvent peaks.

Analysis

For solvent impurities, we commonly employ Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography Mass Spectrometry (LCMS) methods.

In cases where highly volatile solvents with low boiling points are present, we also use Headspace Gas Chromatography (HS-GC). This technique directly vaporizes the substance into the headspace gas for analysis, providing enhanced sensitivity and reduced background interference.

Reporting

Our experienced analytical chemists analyze the data obtained from instruments. We generate a comprehensive report that includes information about the detected solvents, their concentrations, and compliance with permissible limits based on their classification (Class 1, Class 2, or Class 3).

Consultation and Guidance

If clients have any questions or require further guidance on the results, our experts are available for consultation and guidance.

The comprehensive approach to residual solvent testing of Protheragen-ING ensures that products meet safety standards and regulatory requirements. For more information or to initiate your testing demand, please contact us.