LCMS (Liquid Chromatography-Mass Spectrometry) is one of the best analytical instrument in the pharmaceutical, biotech, and chemical industries. It’s important to know how much the LCMS analysis service costs so you can budget and choose the right partner lab, whether you’re validating APIs, profiling contaminants, or measuring biomarkers.
Global pharmaceutical firms trust the in-depth LCMS solutions we offer at ResolveMass Laboratories Inc. In this blog, we’ll go over the cost structure, talk about what affects prices, give you a real-world example, and give you all the information you need to know before you invest in LCMS analysis.
What is LCMS Analysis?
Liquid Chromatography-Mass Spectrometry (LCMS) is an advanced analytical method that separates, identifies, and quantifies compounds in complex mixtures. It is widely used in:
- Impurity profiling (Read More)
- Extractables and leachables testing (Explore Now)
- Bioanalytical quantification (Learn More)
This powerful technology helps pharmaceutical scientists generate highly sensitive, reproducible, and regulatory-compliant data.
Understanding LCMS Analysis Service Cost
The LCMS analysis service cost typically ranges from $500 to $3000+ per sample depending on multiple parameters, such as complexity, customization, and turnaround time.
Key Factors That Influence LCMS Analysis Service Cost
1. Sample Type & Matrix Complexity
Biological matrices (plasma, urine, tissue homogenates) often need extensive cleanup and method development. This raises costs significantly compared to simpler samples like pure drug substances.
2. Analytical Objectives
The cost of LCMS analysis varies depending on whether you need:
- Basic qualitative data
- Quantitative data (PK/PD studies)
- Impurity profiling
- Metabolite identification
3. Method Development vs Pre-validated Methods
Custom method development involves:
- Analytical target profile (ATP) setup
- Optimization of LC gradients
- MS tuning and validation
Pre-validated methods typically cost less but may not fit all product-specific requirements.
4. Instrument Sensitivity & Configuration
High-end systems (like LC-MS/MS or Q-TOF) command higher costs but provide superior specificity and sensitivity.
5. Turnaround Time (TAT)
- Standard TAT (7–15 business days): Budget-friendly
- Rush TAT (48–72 hours): Higher due to resource prioritization
6. Reporting Format & Regulatory Support
GLP-compliant, FDA/EMA-ready reporting formats demand higher documentation and audit trails, thus increasing the LCMS analysis service cost.
7. Number of Samples & Replicates
Bulk testing (10+ samples) usually gets volume discounts, while single-sample testing is billed at premium rates.
Real-World Case Study: LCMS in Nitrosamine Impurity Profiling
Background:
A mid-sized pharmaceutical firm approached ResolveMass Laboratories Inc. to investigate nitrosamine impurities in its ranitidine formulation.
Objectives:
- Identify trace-level NDMA impurities (detection limit: < 30 ng)
- Comply with Health Canada and USFDA guidelines
- Fast TAT: 4 days
Execution:
- Method development using LC-MS/MS (Triple Quad system)
- Plasma-grade sample preparation
- Internal standard calibration
Results:
- NDMA detected at 18.5 ng/mL
- LCMS report included full spectral data, system suitability, validation parameters
- Project completed in 3 business days
The client was able to submit data to regulatory authorities within deadline, avoiding a costly product recall.
Why Choose ResolveMass for LCMS Analysis Services?
- Proven Expertise: Decades of experience in pharmaceutical analytics
- Cutting-edge Instruments: Triple Quad LCMS, Orbitrap, Q-TOF
- Regulatory Compliance: GLP, GMP, FDA/EMA-ready documentation
- Flexible Pricing: Transparent cost models to suit startups and enterprise needs
Explore more:
10 Most Asked FAQs on LCMS Analysis Service Cost
1. Do LCMS analysis costs vary between labs?
Yes, pricing varies based on equipment quality, expertise, location, and service scope. It’s important to choose a lab with proven quality and transparent pricing.
2. Can I get a discount for bulk samples?
Yes, definitely. At ResolveMass Laboratories Inc., we know that larger projects often involve testing many samples—whether it’s for regulatory filings, R&D, or routine quality checks. That’s why we’re happy to offer special pricing for bulk submissions. If you’re planning to send multiple samples—be it for impurity profiling or LCMS-based bioanalysis—we’ll work with you to create a cost-efficient plan that fits your timeline and budget, without compromising on accuracy or service quality. Just reach out to our team, and we’ll take care of the rest.
3. How long does a standard LCMS analysis take?
Typically 5–15 business days. Faster options are available.
4. Do I need method development for each sample type?
Not always. Pre-validated methods reduce cost and TAT.
5. Is LCMS suitable for impurity profiling in generics?
In generics, where the active pharmaceutical ingredient (API) must be chemically equivalent to the innovator product, LCMS provides critical data on:
- Unknown impurities
- Low-level degradants
- Genotoxic contaminants (like nitrosamines)
The FDA and EMA, among other regulatory organizations, also propose or mandate LCMS-based methodologies for impurity profiling, especially for bioequivalence studies and nitrosamine risk evaluations. Its ability to differentiate between structurally related compounds ensures greater specificity and regulatory compliance.
6. Do I get a GLP-compliant report with raw data?
Yes. ResolveMass provides full documentation, chromatograms, and spectra.
7. Can I monitor nitrosamines with LCMS?
Yes, LCMS is a great choice for monitoring nitrosamines. These harmful impurities can show up in trace amounts in certain medicines, and because they’re linked to potential cancer risk, regulators like the FDA and EMA take them very seriously. The good news is, LCMS is incredibly sensitive and accurate—making it perfect for detecting even the tiniest levels of nitrosamines. At ResolveMass Laboratories Inc., we regularly use LCMS to screen for these impurities and help our clients stay compliant with global safety standards, especially in drugs like sartans and ranitidine that are known to be at higher risk.
8. Is LCMS used in extractables and leachables studies?
Yes. It’s crucial for identifying unknown extractables from packaging components.
9. What makes LCMS better than HPLC alone?
Feature | LCMS (Liquid Chromatography-Mass Spectrometry) | HPLC (High-Performance Liquid Chromatography) |
---|---|---|
Detection Sensitivity | Extremely high (ppb to ppt level) | Moderate (ppm to ppb level) |
Molecular Identification | Provides accurate molecular weight and structure info | Limited to retention time and UV/visible absorbance |
Selectivity | Can distinguish closely related compounds and isomers | Less selective—overlapping peaks may not be resolved |
Trace-Level Analysis | Ideal for genotoxic impurities, nitrosamines, and biomarkers | Not suitable for ultra-trace detection |
Structural Elucidation | Yes, using MS/MS fragmentation data | No structural information provided |
Application Scope | Suitable for complex matrices (biological, environmental, etc.) | Mostly limited to simpler formulations |
Regulatory Preference | Often required or preferred for regulatory filings and compliance | Still widely accepted but limited for impurity or metabolite ID |
Data Richness | High—offers quantitative + qualitative data | Mostly quantitative |
Time and Cost | Higher operational cost but delivers comprehensive insights | Lower cost, but limited information |
10. Where can I get a quote for LCMS analysis?
Visit our Contact Page or Request a Quote directly.
Conclusion: Know Before You Go
Understanding the LCMS analysis service cost allows you to make smarter outsourcing decisions. Whether your goal is impurity profiling, extractables testing, or bioanalytical quantification, knowing what drives cost can save both time and money.
ResolveMass Laboratories Inc. provides tailored LCMS services designed for scientists, by scientists. With clear pricing, unmatched experience, and regulatory-ready data packages, we help you go from sample to submission—faster and smarter.
For inquiries, quotes, or project discussions, reach out here:
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
- U.S. Food and Drug Administration (FDA). (2020). Control of Nitrosamine Impurities in Human Drugs. Retrieved from https://www.fda.gov/media/141720/download
- European Medicines Agency (EMA). (2020). Questions and answers on ‘Information on nitrosamines for marketing authorisation holders’. Retrieved from https://www.ema.europa.eu
- International Council for Harmonisation. (2005). ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology. Retrieved from https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf
- Niessen, W. M. A. (2006). Liquid Chromatography–Mass Spectrometry (3rd ed.). CRC Press.
- Zhang, H., & Henion, J. (2001). Comparison of LC-MS and GC-MS for quantitative analysis in drug discovery. Journal of the American Society for Mass Spectrometry, 12(6), 554–561. https://doi.org/10.1016/S1044-0305(01)00248-2
- Kebarle, P., & Tang, L. (1993). From ions in solution to ions in the gas phase – the mechanism of electrospray mass spectrometry. Analytical Chemistry, 65(22), 972A–986A. https://doi.org/10.1021/ac00070a001
Polymer Composition and Structure Analysis
Introduction Polymer Composition Analysis is the foundation for understanding how polymers behave in different industries,…
What Is Extractables and Leachables (E&L) Testing in Infusion Bags? A Complete Guide
Introduction Extractables and Leachables (E&L) Testing in Infusion Bags is one of the most important…
FDA Issues Guidance on Nitrosamine Leachables in Infusion Bags: Risks, Root Causes, and Testing Requirements
Introduction The U.S. Food and Drug Administration (FDA) has recently released new guidance on the…
Polymer Characterization Techniques Explained
Introduction Polymer Characterization Techniques Explained is a guide to the scientific methods used for studying…
Polymer Analysis Techniques & Methods
Introduction Polymer Analysis Techniques are essential for studying the structure, properties, and long-term reliability of…
Case Study: Size Exclusion Chromatography / GPC Analysis of Poly DADMAC Polymers
Introduction Size Exclusion Chromatography (SEC), also known as Gel Permeation Chromatography (GPC), is considered one…