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.
Summary
- Selecting a regulatory-aligned and scientifically qualified laboratory is critical for accurate peptide characterization and successful ANDA/NDA submissions.
- Comprehensive peptide characterization—including purity, identity, impurity profiling, and consistency—is a core FDA and Health Canada expectation.
- Advanced, orthogonal analytical techniques such as HPLC, LC-MS/MS, CE, and NMR are essential to meet regulatory scrutiny for complex peptides.
- Data integrity, method validation, and audit readiness play a decisive role in regulatory acceptance and risk mitigation.
- Specialized expertise is required to characterize modified and complex peptide structures used in modern therapeutics.
- Early alignment of analytical strategy with regulatory timelines improves efficiency, reduces delays, and strengthens submission readiness.
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.
Watch: Regulatory Best Practices for Peptide Characterization Testing
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 Characterization 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 characterization 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 characterization services 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.
Understanding Regulatory Expectations for Peptide Characterization
Regulatory agencies such as the FDA and Health Canada place heightened scrutiny on peptide-based drug products due to their structural complexity and sensitivity to minor chemical changes. Peptides often exhibit micro-heterogeneity arising from synthesis-related impurities, sequence variants, oxidation, deamidation, or aggregation. For ANDA and NDA submissions, regulators expect comprehensive analytical characterization that demonstrates identity, purity, impurity profile, and batch-to-batch consistency in comparison with the reference product.
A qualified laboratory must therefore understand not only how to generate analytical data, but how to present it in a regulatory-acceptable format. This includes traceable raw data, scientifically justified impurity thresholds, and method validation reports aligned with ICH and pharmacopeial expectations. Selecting a lab with direct experience supporting FDA and Health Canada filings significantly reduces the risk of information requests, method-related deficiencies, or delayed approvals.
What Makes a Laboratory Qualified for Peptide Characterization 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 Characterization 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.
Importance of Orthogonal Method Strategies
Peptide characterization cannot rely on a single analytical technique, regardless of how advanced it may be. Regulatory reviewers increasingly expect orthogonal analytical strategies—multiple independent techniques that confirm the same quality attribute from different scientific perspectives. For example, chromatographic purity results obtained by HPLC should be supported by mass-based confirmation using LC-MS and, when applicable, charge-based separation via capillary electrophoresis.
Orthogonal approaches improve confidence in impurity detection, particularly for closely related peptide variants that may co-elute or exhibit similar UV responses. They also help identify analytical blind spots that could otherwise go unnoticed during development. Laboratories experienced in designing orthogonal testing strategies can better defend analytical conclusions during regulatory review and ensure that characterization packages withstand scientific scrutiny.
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.
Data Integrity and Audit Readiness in Regulatory Submissions
Beyond analytical capability, data integrity is a critical factor when selecting a peptide characterization laboratory. Regulatory agencies expect laboratories to follow ALCOA+ principles, ensuring that data are attributable, legible, contemporaneous, original, accurate, and complete. Poor documentation practices, missing audit trails, or inconsistent reporting formats can undermine otherwise sound analytical results.
A submission-ready laboratory maintains controlled electronic systems, secure data storage, version-controlled reports, and clear documentation workflows. This level of rigor supports regulatory audits, method reproducibility, and long-term reference use. Partnering with a lab that prioritizes data integrity reduces compliance risk and strengthens confidence in the analytical package submitted to FDA and Health Canada.
Real-World Applications of Peptide Characterization
Pharma and biotech companies rely on peptide Characterization testing for:
- Final API release
- Reference standard confirmation
- Impurity trend analysis
- Degradation studies
- Stability testing under ICH conditions
Our peptide Characterization 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.
Handling Complex and Modified Peptide Structures
Modern peptide therapeutics increasingly incorporate non-standard features such as cyclization, lipidation, PEGylation, or non-natural amino acids. These modifications improve pharmacokinetics and stability but significantly increase analytical complexity. Not all laboratories are equipped to interpret mass shifts, altered fragmentation patterns, or unusual chromatographic behavior associated with such peptides.
A specialized peptide characterization lab must demonstrate experience with modified structures and advanced data interpretation. This includes understanding how modifications affect ionization efficiency, retention behavior, and degradation pathways. Laboratories that routinely handle complex peptides are better positioned to provide meaningful impurity profiling, accurate identity confirmation, and defensible regulatory documentation.
Early Analytical Strategy Alignment with ANDA Timelines
One of the most overlooked aspects of peptide characterization is early alignment between analytical strategy and regulatory timelines. Waiting until late-stage development to finalize purity methods or impurity thresholds can lead to costly delays, repeat testing, or regulatory pushback. Early engagement with a qualified laboratory allows sponsors to build characterization strategies that evolve alongside formulation and process development.
By establishing validated or qualification-ready methods early, companies can generate comparable datasets across development phases. This continuity simplifies regulatory narratives, supports reference product comparisons, and reduces the need for bridging studies. Laboratories that understand ANDA timelines can proactively guide sponsors toward efficient, submission-ready analytical pathways.
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
Frequently Asked Questions
A peptide is a short chain of amino acids linked together by peptide (amide) bonds, typically containing 2–50 amino acids, which distinguishes it from larger proteins. These molecules have defined N-terminal and C-terminal ends, varying sequences that determine their biological activity (such as hormones or enzyme regulators), and often exhibit high specificity and potency in physiological processes.
Peptides can be classified in multiple ways—commonly by length (e.g., dipeptides, tripeptides, oligopeptides, polypeptides), structure (linear vs. cyclic), origin (natural vs. synthetic), and function (hormonal, antimicrobial, signaling peptides, etc.). These categorizations help describe how peptides behave biologically and how they are used in research or therapeutics.
Peptides intended for therapeutic use as drugs must undergo the FDA’s rigorous approval process, which evaluates safety, efficacy, manufacturing quality, and labeling before they can be legally marketed in the United States. Peptides not approved by the FDA—often sold as “research use only” or supplements—lack that verification and are not legally approved for medical treatment.
Many peptide-based drugs have received FDA approval for clinical use; examples include insulin analogs and GLP-1 receptor agonists like semaglutide and liraglutide for diabetes and obesity, octreotide for hormone-related conditions, and synthetic cyclic peptides like zilucoplan for myasthenia gravis, among others.
To date, the FDA has approved around 100 peptide-based therapeutic agents for various medical indications, and curated databases list hundreds of peptide and protein therapeutics when combined with variants; the peptide drug class continues to grow as new approvals accumulate.
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)
