Residual Solvent Analysis Services at AxisPharm: Precision with Headspace GC-MS and Headspace GC-FID

Ensuring the purity and safety of pharmaceutical products is crucial. Residual solvents, which may remain from manufacturing processes, must be monitored meticulously to comply with stringent regulatory standards. At AxisPharm, we offer advanced residual solvent analysis services utilizing state-of-the-art Headspace Gas Chromatography-Mass Spectrometry (GC-MS) and Headspace Gas Chromatography-Flame Ionization Detection (GC-FID) technologies. Discover how our expert services ensure the highest quality and regulatory compliance for your products.

Why Residual Solvent Analysis Matters

Residual solvents are organic chemicals used or generated during the production of pharmaceuticals, food products, and other chemical goods. Their presence, if not properly controlled, can affect product safety and efficacy. Regulatory bodies, such as the USP (United States Pharmacopeia) and ICH (International Council for Harmonisation), set specific limits for these solvents to protect consumer health. Accurate analysis is essential for:

  • Compliance: Meeting regulatory standards and avoiding potential legal issues.
  • Quality Assurance: Ensuring that products are safe and effective.
  • Safety: Protecting consumers from harmful levels of residual solvents.

Our Advanced Analytical Techniques

At AxisPharm, we leverage two cutting-edge techniques for residual solvent analysis: Headspace Gas Chromatography-Mass Spectrometry (GC-MS) and Headspace Gas Chromatography-Flame Ionization Detection (GC-FID). Each technique offers unique advantages to ensure comprehensive and accurate analysis.

1. Headspace GC-MS

Headspace GC-MS combines the precision of Gas Chromatography with the detailed molecular identification capabilities of Mass Spectrometry. This method is ideal for detecting and quantifying trace levels of residual solvents with high sensitivity and specificity.

  • How It Works:
    • Headspace Sampling: The volatile solvents are separated from the sample matrix by heating the sample and analyzing the gas phase above it.
    • Gas Chromatography: Separates the volatile compounds based on their chemical properties.
    • Mass Spectrometry: Provides detailed molecular information, allowing for accurate identification and quantification of individual solvents.
  • Advantages:
    • High Sensitivity: Detects even trace amounts of residual solvents.
    • Detailed Identification: Offers precise molecular characterization of solvents.
    • Comprehensive Analysis: Suitable for complex samples with multiple residual solvents.

2. Headspace GC-FID

Headspace GC-FID uses Flame Ionization Detection to provide robust and reliable analysis of residual solvents. This technique is particularly effective for quantifying organic compounds and is often employed for routine analysis.

  • How It Works:
    • Headspace Sampling: Similar to GC-MS, this involves analyzing the volatile compounds present in the gas phase above the sample.
    • Gas Chromatography: Separates the compounds based on their interaction with the column material.
    • Flame Ionization Detection: Measures the ions produced when the compounds are burned in a flame, providing quantitative data.
  • Advantages:
    • Robust Detection: Ideal for routine analysis of known residual solvents.
    • Quantitative Precision: Provides accurate measurements of solvent concentrations.
    • Cost-Effective: Suitable for high-throughput testing with reliable results.

Why Choose AxisPharm?

Expertise and Precision: Our team of skilled chemists and analysts employs advanced methodologies to ensure accurate and reliable residual solvent analysis. We adhere to rigorous quality control measures and industry best practices to deliver precise results.

Regulatory Compliance: We stay up-to-date with the latest regulatory standards and guidelines to ensure that your products meet all necessary requirements. Our analysis is aligned with USP, ICH, and other relevant standards.

State-of-the-Art Facilities: AxisPharm is equipped with cutting-edge technology, including the latest Headspace GC-MS and GC-FID instruments, to provide comprehensive analysis and high-quality results.

Customized Solutions: We understand that every product and manufacturing process is unique. Our team offers tailored analytical services to meet your specific needs, ensuring that you receive accurate and actionable insights.

Get in Touch

Ensuring the safety and quality of your products starts with accurate residual solvent analysis. At AxisPharm, we provide expert services using Headspace GC-MS and GC-FID to deliver the precision and reliability you need. Contact us today to learn more about our residual solvent analysis services and how we can assist you in meeting your regulatory and quality assurance goals.

Ref:

Frank Bernardoni, Holst M. Halsey, Robert Hartman, Timothy Nowak, Erik L. Regalado, Generic gas chromatography flame ionization detection method using hydrogen as the carrier gas for the analysis of solvents in pharmaceuticals, Journal of Pharmaceutical and Biomedical Analysis, Volume 165, 2019, Pages 366-373.

Deconinck E, Canfyn M, Sacré PY, Baudewyns S, Courselle P, De Beer JO. A validated GC-MS method for the determination and quantification of residual solvents in counterfeit tablets and capsules. J Pharm Biomed Anal. 2012 Nov;70:64-70.