Selecting a scientifically robust and regulatory-aligned partner for peptide characterization is one of the most critical decisions for any generic drug developer working with peptides. Whether you’re verifying an API sourced from a contract manufacturer or confirming equivalence to a Reference Listed Drug (RLD), comprehensive peptide characterization is central to preparing an Abbreviated New Drug Application (ANDA) for the U.S. FDA.
At ResolveMass Laboratories Inc., we work with pharmaceutical companies, biotech innovators, and research institutions to ensure that their peptide APIs meet stringent analytical and regulatory expectations. This guide will help you evaluate and choose a laboratory based on its analytical capabilities, regulatory experience, and data integrity—ensuring that your characterization results are submission-ready.
If peptide characterization (including purity profiling, LC-MS/MS identity confirmation, amino acid analysis, peptide mapping, content determination, sterility, and endotoxin testing) is part of your ANDA strategy, read on.
Important Notice:
ResolveMass Laboratories works exclusively with pharmaceutical and biotech companies, providing analytical services to support their NDA and ANDA project submissions to FDA and Health Canada for peptides.
We do not offer any testing services to individuals or for personal use. Our services are strictly for business and research purposes only.
Our laboratory operates strictly under a research and development (R&D) framework for the pharma and biotech companies. Testing is intended solely for research purposes to the pharma and biotech companies and is not authorized for clinical or diagnostic decision-making in any forms. For medical use guidance, please consult a licensed healthcare professional.
Peptide Characterization Lab for U.S. Generic Submissions
ResolveMass Laboratories Inc. is a Canada-based analytical CRO specializing in peptide characterization for regulatory filings, serving clients across both Canada and the United States.
Using advanced Liquid Chromatography–Mass Spectrometry (LC-MS/MS), NMR and High-Performance Liquid Chromatography (HPLC), we provide in-depth peptide profiling capable of confirming:
⚠ Important Notice: Our laboratory operates strictly under a research and development (R&D) framework. Testing is intended solely for research purposes and is not authorized for clinical or diagnostic decision-making. For medical use guidance, please consult a licensed healthcare professional..
Why Peptide Purity Testing Services Matter in Drug Development
Peptide-based therapeutics are gaining traction across various indications—from metabolic disorders to oncology. However, impurities arising from synthesis, degradation, or side reactions can compromise efficacy and safety. This is why peptide purity testing services are mandatory in:
- Preclinical studies
- IND and NDA submissions
- cGMP lot release
- Reference standard validation
- Quality control (QC) of bulk peptide APIs
A laboratory offering peptide purity testing must deliver data that meets the analytical expectations of regulatory bodies like the FDA, EMA, and Health Canada.
To learn more about our peptide characterization workflows, visit our Peptide Sequencing Service page.
What Makes a Laboratory Qualified for Peptide Purity Testing?
Not all labs that offer analytical services are capable of high-quality peptide purity testing. Here’s what to look for:
Scientific Expertise in Peptide Chemistry
The lab should have PhD-level chemists or biochemists with expertise in peptide synthesis, degradation mechanisms, and post-translational modifications. This ensures proper interpretation of data from complex peptides.
Validated Analytical Methods
A reliable peptide purity testing laboratory uses validated methods in accordance with ICH Q2 (R1) guidelines. These include linearity, precision, accuracy, LOD/LOQ, and robustness.
ResolveMass specializes in analytical method development for complex peptide APIs. Learn how we apply our peptide sequencing service in support of impurity profiling.
Key Techniques Used in Peptide Purity Testing Services
Laboratories offering peptide purity testing services should offer a suite of complementary methods to ensure analytical depth and precision:
High-Performance Liquid Chromatography (HPLC)
The gold standard for purity profiling, HPLC can detect major and minor impurities at sub-percent levels. At ResolveMass, we use C18 columns and UV detection at 214 nm and 280 nm wavelengths.
LC-MS (Liquid Chromatography–Mass Spectrometry)
Mass spectrometry adds molecular confirmation to chromatographic data. It detects co-eluting species, truncated peptides, and mass-based impurities with high precision.
Capillary Electrophoresis (CE)
This orthogonal technique helps verify HPLC results and is especially effective for hydrophilic peptides and isomer separation.
MALDI-TOF
Matrix-assisted laser desorption/ionization time-of-flight is valuable for peptide mapping and profiling high-mass peptides, including conjugates.
For a full overview of our instrumentation, explore our Peptide Sequencing Service workflows.
Common Mistakes to Avoid When Choosing a Peptide Purity Testing Lab
Many labs claim to offer peptide purity testing, but not all meet industry standards. Here are some red flags:
- Labs that do not use MS or CE alongside HPLC
- Lack of ISO, GLP or GMP certification
- No method validation process
- Generic reporting with limited transparency
- Inexperience with non-natural or modified peptides
At ResolveMass, we combine regulatory expertise with deep knowledge in peptide characterization. Explore our specialized peptide testing services to see how we mitigate these risks.
Real-World Applications of Peptide Purity Testing
Pharma and biotech companies rely on peptide purity testing for:
- Final API release
- Reference standard confirmation
- Impurity trend analysis
- Degradation studies
- Stability testing under ICH conditions
Our peptide purity testing services are routinely used in IND and NDA filings. We support peptide-drug conjugates, cyclic peptides, and peptides with phosphorothioate or DMCO-C6 modifications.
To see how our lab supports these advanced projects, visit our Peptide Sequencing Service.
Conclusion – Partner with ResolveMass for Trusted Peptide Characterization Testing Services
Choosing the right laboratory for peptide Characterization testing is essential to ensure accurate, reproducible results that meet both scientific and regulatory expectations. At ResolveMass Laboratories Inc., we combine deep expertise, validated methods, and regulatory-ready documentation to provide unmatched support across all stages of your peptide development program.
From HPLC and LC-MS to orthogonal confirmation techniques, our peptide testing services are trusted by pharma companies and researchers across North America. With a reputation for data quality and technical integrity, ResolveMass is the partner you can rely on.
Contact Us to Get Started
📩 Submit Your Peptide for Testing
📞 Contact Our Technical Team
🧪 Request a Custom Testing Quote
🔍 Discuss Your Peptide Purity Testing Project
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.
Ready to Get Started?
📩 Contact our expert team
📞 Request a quote for method development
📅 Book a consultation with our scientists
🧪 Submit your sample for testing
References:
Z.K. Shihabi, CAPILLARY ELECTROPHORESIS | Clinical Applications, Editor(s): Paul Worsfold, Alan Townshend, Colin Poole, Encyclopedia of Analytical Science (Second Edition), Elsevier, 2005, Pages 381-392, ISBN 9780123693976, https://doi.org/10.1016/B0-12-369397-7/00750-0. (https://www.sciencedirect.com/science/article/pii/B0123693977007500)
