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Peptide Analytical Services

Characterization and testing for peptides and peptide-based materials — aligned with GLP / ISO 13485 quality systems (non-GMP).

Fit-for-purpose peptide analytics with traceable reporting for discovery, development, and regulated programs.

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Analytical HPLC MALDI-TOF LC-MS Identity confirmation Endotoxin (qual & quant) GLP / ISO 13485 aligned
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Overview Services Sample guidance Deliverables Contact

Overview

What analytical testing answers

Peptide analytical testing verifies that the material you received is the material you intended to use — and that key attributes are within acceptable ranges for your application.

  • Identity: confirm sequence / mass
  • Purity: quantify and trend impurities
  • Safety: endotoxin and bioburden when required
  • Composition: counterion, salts, water content, residuals

Services are aligned with GLP / ISO 13485 quality systems for regulated non-GMP needs. GMP manufacturing is not offered.

How we approach peptide analytics

We select methods that match your peptide chemistry, concentration range, and reporting needs. When appropriate, we combine orthogonal techniques (e.g., HPLC + MS) to strengthen confidence in identification and impurity assessment.

Fit-for-purpose reporting Traceability Orthogonal confirmation Controlled workflows
  • Review: sequence, modifications, matrix, constraints
  • Test: select analytical methods appropriate to the question
  • Confirm: identity and/or purity with supporting evidence
  • Report: COA-style summary and data package (as scoped)
Peptide Identification using Mass Spectrometry laboratory
Peptide analytical testing workflows supporting identity, purity, and safety-related assessments.

Analytical Services

Expand each service for sample submission guidance and technical notes. Services are aligned with GLP / ISO 13485 quality systems for regulated non-GMP programs.

Quantitative compositionMass balance supportNormalization option

Quantitative amino acid composition supports compositional confirmation, concentration normalization, and mass-balance interpretation—especially useful when UV response may not reflect true mass.
Explore more details about Amino Acid Analysis >>>

  • Quantitative amino acid composition profile (scope-dependent)
  • Supports identity / composition confirmation for longer or complex peptides
  • Useful for concentration normalization and cross-checking label claims
Sample submission
  • Preferred format: lyophilized peptide; ≥0.5 mg recommended (more may be needed for replicate/confirmatory work).
  • Provide theoretical sequence and expected amino acid composition (including any non-standard residues).
  • Disclose unusual modifications that may affect hydrolysis or quantitation.
Sample data & technical notes
  • Reported as molar ratios and/or composition values (scope-dependent).
  • Optional comparison to theoretical composition with interpretation notes.
  • Hydrolysis-sensitive residues and modification effects noted when applicable.

Purity (%)Impurity profilingMethod alignment option

Analytical HPLC is the primary method for peptide purity determination and impurity profiling. Methods are selected to match peptide chemistry and the question you need answered (release, comparison, or stability trending).
Explore more details about Analytical HPLC >>>

  • Purity (%) by peak area normalization (unless otherwise specified)
  • Chromatographic impurity profile with retention times
  • Optional peak table and batch-to-batch comparability (as scoped)
Sample submission
  • ≥0.2–0.5 mg recommended; specify if sample is crude vs purified.
  • If submitting in solution, provide solvent/buffer and concentration.
  • Share preferred conditions (column/mobile phase/gradient) if you need method alignment.
Sample data & technical notes
  • Chromatogram (PDF) with annotated main peak and key impurities (as scoped).
  • Purity value and method summary; peak table available upon request.
  • Notes on co-elution risk and recommended orthogonal confirmation (e.g., LC-MS) when needed.

MALDI-TOFLC-MSModification screening

Mass spectrometry supports identity confirmation and strengthens impurity interpretation. MALDI-TOF provides rapid intact mass checks; LC-MS adds separation for complex mixtures or challenging matrices.
Explore more details about Mass Apectrometry >>>

  • MALDI-TOF: fast intact mass confirmation for many peptides
  • LC-MS: separation + MS evidence for complex impurity sets
  • Supports detection of mass shifts (oxidation, truncations, adducts) when feasible
Sample submission
  • ≥ 0.1 mg recommended; provide expected molecular weight and sequence.
  • Indicate known modifications, labels, or isotopic enrichment.
  • If matrix is complex (salts/buffers), specify—LC-MS may be preferred.
Sample data & technical notes
  • Observed m/z values and comparison to theoretical mass.
  • LC-MS: extracted ion chromatograms / retention behavior (as scoped).
  • Notes on common adducts and interpretation limitations where applicable.

Orthogonal confirmationTraceable reportingDocumentation-ready

Identity confirmation integrates orthogonal evidence (commonly HPLC + MS) to support assignment of the intended peptide and strengthen confidence in documentation packages.
Explore more details about Peptide Identity Confirmation >>>

  • Identity assignment supported by mass evidence (and chromatography when applicable)
  • Cross-check against expected MW / modification state
  • Optional inclusion in a consolidated data package (as scoped)
Sample submission
  • Provide sequence, modifications, and expected MW.
  • Specify if identity is for a single peptide or a panel of related sequences.
  • Share any acceptance criteria or reporting templates (if applicable).
Sample data & technical notes
  • Identity statement supported by MS evidence (and HPLC trace when included).
  • Notes on ambiguity (e.g., isobaric species, co-elution) and recommended follow-up if needed.
  • COA-style summary available depending on scope.

Counterion contentConversion checkSolubility relevance

Counterions can affect solubility, stability, pH, and mass balance. Counterion analysis quantifies counterion content and supports conversion verification (e.g., TFA → acetate).
Explore more details about Counterion Analysis >>>

  • Counterion identification and quantitation (as scoped)
  • Supports conversion verification and specification alignment
  • Helps explain solubility or pH behavior differences
Sample submission
  • Provide expected counterion (if known) and sample format.
  • If you performed a counterion exchange, describe the process and target form.
  • Avoid highly buffered matrices unless discussed (may complicate interpretation).
Sample data & technical notes
  • Reported counterion identity and content (scope-dependent).
  • Notes on multi-counterion scenarios and mass balance implications.
  • Recommendations if conversion appears incomplete (as applicable).

Qual + QuantoESTURB (glucan blocking)EU reporting

Endotoxin testing supports safety-related requirements. We offer qualitative screening and quantitative measurement; quantitative option is available using oESTURB (Endotoxin‑Specific Kinetic Turbidimetric Assay with Glucan Blocking) when appropriate.
Explore more details about Endotoxin Assay Testing >>>

  • Qualitative: presence/absence style screening (as scoped)
  • Quantitative: reported in EU/mL or EU/mg (as scoped)
  • Supports GLP / ISO 13485 aligned documentation (non-GMP)
Sample submission
  • Use endotoxin-free containers; avoid non-validated consumables.
  • Provide sample matrix details (solvent, buffers, detergents) to assess interference risk.
  • Submit enough material for dilution series and inhibition/enhancement checks (scope-dependent).
Sample data & technical notes
  • Qualitative: pass/fail style output (as scoped).
  • Quantitative: EU results with method note (including oESTURB when used).
  • Interpretation notes on matrix interference and recommended dilution strategy (if relevant).

Microbial loadControlled handlingNon-GMP documentation

Bioburden testing evaluates microbial contamination risk for applications requiring controlled microbial levels and supports documentation needs for regulated non-GMP workflows.
Explore more details about Bioburden Assay >>>

  • Bioburden assessment (scope-dependent)
  • Complements endotoxin testing when both are required
  • Documentation aligned to GLP / ISO 13485 systems (non-GMP)
Sample submission
  • Submit in sterile, sealed containers; minimize handling before shipment.
  • Provide sample type (powder/solution), solvent/buffer, and expected load (if any).
  • If sample is antimicrobial, disclose—may affect recovery and method selection.
Sample data & technical notes
  • Reported bioburden result with method summary (as scoped).
  • Notes on recovery limitations for inhibitory matrices (if applicable).
  • Optional handling/storage recommendations to reduce contamination risk.

Salt contentMass balanceConcentration support

Salt content can influence mass balance, concentration calculations, and formulation behavior. Salt content analysis supports interpretation of dosing and assay concentrations.
Explore more details about Salt Content Analysis >>>

  • Salt content measurement (as scoped)
  • Supports concentration calculations and mass balance interpretation
  • Useful when salts are introduced during processing or exchange
Sample submission
  • Provide sample format and any known salt forms introduced during processing.
  • If in solution, provide buffer identity and concentration.
  • Disclose hygroscopic behavior (if observed) to guide handling.
Sample data & technical notes
  • Reported salt content result (scope-dependent) with method note.
  • Interpretation notes for mass balance and concentration calculations.
  • Flags for variability if sample is highly hygroscopic or heterogeneous.

Moisture levelHandling guidanceStability support

Water content affects storage stability, handling, and mass calculations. Water content analysis provides moisture levels to support specifications and stability interpretation.
Explore more details about Water Content Analysis >>>

  • Water content measurement (scope-dependent)
  • Supports mass balance / assay concentration interpretation
  • Helpful for hygroscopic peptides and storage planning
Sample submission
  • Submit tightly sealed; minimize exposure to ambient humidity.
  • Provide storage history if known (room temp vs frozen/desiccated).
  • For hygroscopic samples, ship with desiccant when appropriate.
Sample data & technical notes
  • Reported water content with method note (as scoped).
  • Interpretation notes for handling and storage.
  • Optional comparison across lots/time points in stability programs.

ResidualsTroubleshootingSpec alignment

Residual chemical analysis supports identification and control of synthesis- or processing-related residuals when carryover risk is a concern or when documentation requires residual assessment.
Explore more details about residual chemical analysis >>>

  • Residual chemical assessment (scope-dependent)
  • Useful for process troubleshooting and release documentation
  • Aligned to project risk and matrix constraints
Sample submission
  • Provide process context when available (suspected residual classes).
  • Indicate sample format and any solvents used for dissolution.
  • If you have internal limits/specs, share them for reporting alignment.
Sample data & technical notes
  • Reported residual findings (scope-dependent) with method note.
  • Interpretation notes on potential sources and follow-up options.
  • Optional inclusion in a consolidated data package (as scoped).

pHCompatibilityStability endpoint

pH analysis supports solution-form materials, formulation compatibility, and stability planning for peptides where pH influences solubility or degradation pathways.
Explore more details about pH analysis >>>

  • pH measurement (scope-dependent)
  • Supports buffer compatibility and formulation development
  • Useful as a stability endpoint for solution samples
Sample submission
  • Provide sample in solution when possible; specify buffer and concentration.
  • If submitting powder, specify reconstitution solvent and target concentration.
  • Indicate if CO₂ sensitivity is a concern (carbonate/bicarbonate systems).
Sample data & technical notes
  • Reported pH with conditions (temperature, matrix) as scoped.
  • Interpretation notes for formulation compatibility (when applicable).
  • Optional trending across stability time points.

Feasibility screenHandling guidanceBuffer selection

Solubility testing evaluates practical solubility in user-relevant solvents/buffers and helps identify conditions that reduce precipitation or aggregation (sequence-dependent).
Explore more details about solubility analysis >>>

  • Solvent/buffer feasibility screen (as scoped)
  • Supports selection of working stocks and assay buffers
  • Provides handling notes when precipitation/aggregation is observed
Sample submission
  • Provide intended solvents/buffers, pH range, and concentration targets.
  • Disclose constraints (e.g., must avoid DMSO, detergents, high salt).
  • Submit enough material to run multiple conditions and replicates (scope-dependent).
Sample data & technical notes
  • Reported solubility observations and achievable concentration ranges (as scoped).
  • Notes on precipitation timing, temperature sensitivity, and mixing requirements.
  • Recommendations for improved solubility (pH shift, counterion, cosolvent) within constraints.

Time pointsTrendable outputRisk-aligned panels

Stability studies evaluate changes over time under defined storage conditions. We support time-point scheduling and panel selection based on risk profile and intended use.

  • Time-point planning (baseline + defined intervals)
  • Panel may include HPLC profile/purity, MS check, water content, pH, and other attributes (as scoped)
  • Trend reporting supports interpretation of degradation and variability
Sample submission
  • Define storage conditions (temperature/light/humidity) and container type.
  • Specify time points (e.g., T0, 1w, 2w, 1m, 3m) or request recommendations.
  • Provide sample quantity per time point and any acceptance criteria.
Sample data & technical notes
  • Time-point data package with method notes (as scoped).
  • Trend commentary: new peaks, purity drift, mass shifts, moisture changes (as applicable).
  • Optional summary table for quick program review.

One requestConsolidated reportingFit-for-purpose

Bundled panels simplify ordering and reduce back-and-forth on scope. Choose a panel when you want a consolidated package aligned to your application and documentation needs.

  • Identity + purity bundle (HPLC + MS) for most workflows
  • Add counterion/salt/water/residuals as needed
  • Add endotoxin/bioburden when safety-related testing is required
Sample submission
  • Tell us your intended use (assay, in vivo, regulated non-GMP) and deadline.
  • Provide sequence, modifications, sample format, and target quantities.
  • Share internal specifications so the panel matches your requirements.
Sample data & technical notes
  • Consolidated COA-style summary plus supporting analytical outputs (as scoped).
  • Method notes and traceable reporting aligned to GLP / ISO 13485 systems (non-GMP).
  • Consultative recommendation for the smallest panel that answers your question.

Sample Guidance

What to include with your request
  • Sequence + modifications (and expected molecular weight if available)
  • Sample format (lyophilized powder or solution), solvent/buffer details
  • Target questions (identity, purity, endotoxin, counterion, etc.)
  • Any known risks: oxidation, solubility issues, stickiness, aggregation
  • Required reporting format (if you have templates or internal specs)
Practical notes
  • If endotoxin testing is required, discuss matrix constraints and potential dilution needs.
  • For complex mixtures, LC-MS may provide stronger evidence than MS alone.
  • For stability studies, define storage conditions and time points before testing begins.

If you’re unsure which tests to run, describe the intended application and we’ll recommend a fit-for-purpose plan.

Deliverables & Reporting

Typical deliverables
  • COA-style summary of requested tests (scope-dependent)
  • Analytical HPLC chromatograms and purity assessment
  • MS evidence (MALDI-TOF and/or LC-MS as scoped)
  • Endotoxin results (qualitative and/or quantitative, as requested)
  • Supporting records for counterion/salt/water/residuals/bioburden/pH (as scoped)

Deliverables can be tailored to your internal documentation requirements.

Quality system alignment
  • Controlled documentation and traceability
  • Instrument maintenance and method recordkeeping
  • Sample custody and labeling discipline
  • Change awareness when conditions must be adjusted

Services are aligned with GLP / ISO 13485 quality systems for regulated non-GMP programs. GMP manufacturing is not offered.

Example stability schedule (template)

Time points and test panels are program-specific. This is a planning template.

Time point Typical tests Notes
T0 (baseline) HPLC profile + purity; MS identity; optional pH/water/counterion Establish baseline attributes before storage
Midpoint HPLC profile + purity; optional MS; pH/water as needed Detect early shifts (degradation, new peaks)
Final HPLC profile + purity; MS identity; supporting chemistry tests as required Confirm end-of-study profile and interpret trends

Request a Quote

What to provide
  • Sequence + modifications (or product identifier)
  • Sample format (powder/solution), solvent/buffer and concentration (if applicable)
  • Which tests you need (HPLC, MS, endotoxin, counterion, etc.)
  • Any known constraints (matrix effects, limited quantity, deadlines)
  • Reporting requirements (if you have templates/specs)
  • Shipping destination and timeline

If you’re not sure which panel to request, tell us the intended use-case and we’ll recommend a fit-for-purpose plan.

Share your peptide details and testing goals. Our team will recommend a method plan and provide a quote aligned to your timeline and reporting needs.

Fastest path
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