When seeking a high-quality impurity identification service, choosing the right analytical method is a crucial. Pharmaceutical, biotechnology, and chemical manufacturing companies frequently encounter unknown impurities during formulation, stability testing, degradation, or API synthesis. It is the most important to have knowledge on various techniques which can be used for identification and characterization.
At ResolveMass Laboratories Inc., we specialize in advanced impurity identification services using state-of-the-art LC-MS/MS, NMR, and GC-MS platforms. We have PhD level scientist who share this knowledge to you so that you can excel in your impurity identification project. This guide will help you understand all the relevant technical aspects, still if you need more help to understand more in your impurity identification, feel free to book a free consultation with our scientist for your project.
What is an Impurity Identification Service?
An impurity identification service is an analytical offering designed to detect, characterize, and quantify unknown chemical entities—impurities—present in pharmaceutical or chemical products. These impurities could arise from synthesis, degradation, or contamination. Regulatory bodies like the FDA, EMA, and Health Canada require comprehensive profiling of these substances.
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Why Method Selection Matters in Impurity Identification Service
Not all impurities are the same. Their volatility, polarity, thermal stability, and molecular structure influence which analytical method should be used. Choosing the correct approach ensures higher sensitivity, structural accuracy, and compliance-readiness.
Let’s explore the three dominant methods used in a professional impurity identification service:
LC-MS/MS in Impurity Identification Service
Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) is one of the most powerful tools for impurity analysis, particularly in complex matrices like drug products, drug substances or biological samples.
When to Use LC-MS/MS:
- Non-volatile, thermally labile compounds
- Trace-level impurity detection
- Structural elucidation of polar compounds
- Drug metabolites
Advantages:
- High sensitivity (ppm to ppb level) and selectivity
- Quantitative and qualitative data
- Suitable for complex formulations
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GC-MS in Impurity Identification Service
Gas Chromatography-Mass Spectrometry (GC-MS) is ideal for volatile and thermally stable impurities often found in residual solvents, extractables/leachables, or volatile degradation products.
When to Use GC-MS:
- Volatile and semi-volatile impurities
- Residual solvents profiling (per USP <467>)
- Extractables & leachables studies
Advantages:
- Excellent separation efficiency
- Reliable for low molecular weight compounds
- High reproducibility
This method often complements LC-MS/MS for a comprehensive impurity identification service.
NMR in Impurity Identification Service
Nuclear Magnetic Resonance (NMR) provides unparalleled insight into the complete structural layout of unknown impurities. It’s often used in confirmatory testing or when mass spectrometry alone is insufficient.
When to Use NMR:
- Full structural elucidation of unknowns
- Confirming stereochemistry and molecular framework
- Detecting non-ionizable or MS-invisible impurities
Advantages:
- Non-destructive analysis
- Unbiased chemical structure determination
- Excellent for late-stage API impurity resolution
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How ResolveMass Integrates These Techniques
ResolveMass Laboratories Inc. applies a tiered and integrative approach to impurity identification. Depending on your sample’s physical and chemical characteristics, our analysts may use LC-MS/MS for initial detection, followed by GC-MS for volatile analysis and NMR for full structure confirmation. This ensures no impurity goes undetected.
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Choosing the Right Method for Your Impurity Identification Service
Here’s a simplified decision matrix:
| Impurity Type | Recommended Method |
|---|---|
| Volatile solvents | GC-MS |
| Non-volatile polar compounds | LC-MS/MS |
| Unknown structure | NMR |
| Degradation products | LC-MS/MS + NMR |
| Leachables & extractables | GC-MS |
Selecting the right platform ensures regulatory compliance and speeds up your path to submission.
Regulatory Considerations in Impurity Identification
For ANDA/NDA submissions, impurity data must comply with ICH Q3A/B guidelines. All unknown impurities above reporting thresholds must be structurally characterized. Our impurity identification service is designed with regulatory requirements in mind.
ResolveMass offers high-quality analytical documentation, including method validation, CoAs, and impurity profiling reports tailored for regulatory audits.
Why Choose ResolveMass for Your Impurity Identification Service?
ResolveMass Laboratories Inc. is a North American leader in impurity profiling with:
- A dedicated team of PhD analytical chemists
- Advanced LC-MS/MS, GC-MS, and NMR infrastructure
- Rapid turnaround time and custom workflows
- Audit-ready reports for regulatory compliance
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Conclusion: What’s Best for Your Impurity Identification Service?
The right analytical platform for your impurity identification service depends on the impurity’s nature, your development stage, and regulatory goals. Whether it’s LC-MS/MS for trace impurities, GC-MS for volatiles, or NMR for complete structural confirmation, ResolveMass Laboratories has the tools and expertise to deliver precise results.
Explore our capabilities:
Need help choosing the right method? Contact our technical team now for a custom plan.
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ResolveMass Laboratories Inc.: Comprehensive Scientific Expertise You Can Rely On
ResolveMass Laboratories Inc. is a trusted Canadian contract research organization offering a wide spectrum of specialized services spanning polymer synthesis, advanced analytical testing, and custom organic synthesis. With over a decade of experience supporting pharmaceutical, biotech, and industrial clients, we bring scientific precision and regulatory insight to every project. Our core capabilities include Polymer Synthesis and Characterization, Peptide Characterization, Organic Synthesis, Nitrosamine Testing and Analysis, PFAS Testing, and Extractable & Leachable Studies, as well as a broad suite of analytical techniques such as HPLC, GC-MS, MALDI-TOF, NMR, and FTIR.
Our multidisciplinary team includes chemists, analytical scientists, and regulatory experts with advanced academic and industry backgrounds. We excel at developing customized, high-quality solutions—whether you need innovative polymer designs, impurity profiling, or confirmatory testing that meets global regulatory standards.
Clients across North America choose ResolveMass Laboratories for our deep technical knowledge, commitment to quality, and ability to deliver reproducible, reliable data that drives confident decision-making. When precision, innovation, and trust matter—ResolveMass is your partner of choice.
References:
2. FDA Guidance for Industry: Q3B(R2) – Impurities in New Drug Products
3. European Pharmacopoeia (Ph. Eur.) General Chapter 2.2.46 – Chromatographic Separation Techniques
