The analytical laboratory built for peptides, not adapted to them.
Purity and potency with mass spec identification. Rapid sterility in days rather than weeks. Counterions, aggregates, and degradants measured rather than assumed. Chemistry and microbiology in one building in San Diego, so one shipment closes out a release.
A peptide is not a small molecule, and a generic assay treats it like one.
Most laboratories run peptides through methods designed for small molecule actives. The result is a number that looks reportable and is quietly wrong. These are the five failure modes we see most often.
Counterion residuals nobody measures
Peptides purified by preparative HPLC carry trifluoroacetate or acetate out of the mobile phase, sometimes at several percent by mass. TFA is cytotoxic at meaningful levels and has no compendial limit for most peptides, so it goes unreported. We quantify both by ion chromatography, with acetic acid per USP <503>.
Aggregates that never leave the column
Reverse phase purity misses dimers, trimers, and higher order species that coelute with the parent or stay on the column. Aggregation drives immunogenicity risk, it increases on storage and on reconstitution, and size exclusion is the only routine way to see it.
Degradants that mimic the drug
Deamidation shifts mass by one unit. Oxidation adds sixteen. Racemization changes nothing at all about the mass. All three produce species that sit near the parent peak. Without mass confirmation across the impurity profile, a failing lot reads as a clean chromatogram with slightly low potency.
Net peptide content versus vial weight
A lyophilized cake is peptide plus water plus salt plus counterion. Weighing it and calling it 5 mg overstates the delivered dose, often by ten to twenty percent. Total peptide mass separates what reaches the patient from what went into the vial.
No monograph, no default method
Very few of the peptides in circulation have a USP monograph. There is no compendial assay to fall back on, which means somebody has to develop and validate one that resolves the parent from its degradation products. That is a method development project, not a catalog test, and pretending otherwise is where most bad data starts.
Sterility results in days, not weeks.
The compendial test in USP <71> needs a 14 day incubation. For a short dated sterile peptide, that is most of the useful shelf life spent in quarantine. We run two rapid alternatives alongside the compendial method, so you can choose the timeline the product actually needs.
Method suitability on your formulation has to be on file before any of the three produces a usable result. We run suitability as a standalone study, so it is done once and never blocks a release again.
Instrumentation and capability
What sits on the bench decides which questions we can answer. Peptide work needs a separation that resolves close impurities and a detector that can tell you what they are.
Testing services
Our standard chemical, biological, method suitability, and product qualification services. Pricing is quoted per sample, and volume pricing and custom method development are available on request.
Chemical tests What is in the vial, and how much of it
| Test | Method | What is reported |
|---|---|---|
| Target Chemical ProfileThe bundle most clients order | Reverse phase chromatography with mass spectrometric identification | Potency, chromatographic purity, total impurities, largest single impurity, and mass spec identification on one certificate |
| Expanded purity | Reverse phase chromatography with UV detection | Chromatographic purity, total impurities, largest single impurity |
| Potency and total peptide massTotal peptide mass is the potency equivalent for solids | Quantitative chromatography against a reference standard | Percent of label claim, or peptide mass per container |
| Mass spec identification | Liquid chromatography mass spectrometry | Confirmation of identity against expected mass |
| Aggregate analysis | Size exclusion chromatography | Dimers, higher order species, and percent aggregate |
| Trifluoroacetate (TFA) and acetate (AA)No compendial TFA limit exists, which is exactly why it matters | Ion chromatography | Residual counterion concentration for both species |
| Heavy metals | ICP-MS | Elemental concentrations against applicable limits |
| Metals and elementals | ICP-MS and ICP-OES | Extended elemental panel |
| Volatile organic compounds (VOCs) | Volatiles screen | Identity and concentration of residual solvents and volatiles |
| pH | Potentiometric | pH of solution as received or as reconstituted |
Biological tests Sterility, endotoxins, preservative performance
| Test | Method | Turnaround |
|---|---|---|
| Sterility by ScanRDI®Fastest route to release | Solid phase cytometry with viability labeling. No incubation period, so detection does not wait for growth | Quoted with your order |
| Sterility by Celsis® | Rapid detection by ATP bioluminescence | 5 to 7 days |
| Sterility by USP <71> | Membrane filtration or direct inoculation | 14 days |
| Bacterial endotoxins | Kinetic chromogenic LAL with spike recovery run in duplicate | Quoted with your order |
| Antimicrobial effectiveness | Challenge study for multi dose containers, with log reduction measured at set intervals | 28 day challenge period |
| Container closure integrity | Dye ingress with UV-Vis spectrophotometric detection | Quoted with your order |
Method suitability Required once per formulation, before results mean anything
| Study | What it establishes | When it is needed |
|---|---|---|
| ScanRDI® method suitability | Recovery and absence of interference from your formulation on the ScanRDI platform | Before any ScanRDI sterility result |
| Celsis® method suitability | Growth promotion of the media and absence of inhibition by your formulation | Before any Celsis sterility result |
| Endotoxin method suitability | Non interference and the maximum valid dilution for your product | Before any endotoxin result |
| Potency method suitability | Confirms the potency assay performs on your specific formulation and matrix | Before routine potency testing |
Suitability is per formulation, not per batch. Change the formulation and it has to be repeated. Plan it well ahead of your first release, because it cannot be compressed and nothing ships without it.
Product qualification Studies that support a dating claim
| Study | Design | Duration |
|---|---|---|
| Beyond use date studyAccelerated studies also available | Real time aging designed in accordance with USP <797>, stored at recommended conditions. Sterility, endotoxins, Target Chemical Profile, container closure integrity, pH, and antimicrobial effectiveness at 30 day intervals. Method suitability required first | 120 days |
| Temperature excursion study | Monitoring of product quality after exposure to out of specification storage, across five testing intervals. Elevated and reduced temperature storage both available | 120 hour exposure window |
Turnaround runs from sample receipt and assumes a method and reference standard are on file and any suitability study is complete. Where we do not yet have a developed method for an active in your sample, we will say so and quote method development before testing starts.
The peptides we work with
A validated method already on file is the difference between catalog turnaround and a method development project. Send us the peptide and we will tell you which one you are looking at before you ship anything.
Metabolic and incretin peptides
The GLP-1 and dual agonist class, along with the amylin analogs and appetite regulating peptides now compounded alongside them.
Growth hormone secretagogues
Releasing hormones and releasing peptides, including modified and long acting analogs where the modification itself is the analytical challenge.
Tissue repair and recovery peptides
Short sequence repair peptides and copper complexes, where identity and purity claims vary widely between suppliers.
Immune and thymic peptides
Thymic fragments and immunomodulatory sequences, typically presented as lyophilized sterile vials.
Neurological and cognitive peptides
Short neuroactive sequences and their analogs, often with limited published characterization data to compare against.
Mitochondrial and longevity peptides
Mitochondrial derived peptides and targeted analogs, where aggregation and degradation on storage are the usual findings.
Endocrine and hormone analogs
Established hormone analogs, many with compendial precedent, compounded in both single and multi dose presentations.
Anything not on this list
Custom method development is quoted before it starts. Four to six weeks for a stability indicating method, and you own the validation package at the end of it.
Packaged programs
Most clients do not want to assemble a panel from a catalog. These are the four combinations we are asked for most, priced as a package.
Sterile finished product release
Everything needed to release a filled, sealed vial of sterile peptide preparation.
- Target Chemical Profile
- pH
- Bacterial endotoxins
- Sterility by ScanRDI® or Celsis®
- Container closure integrity
API and bulk qualification
Full characterization of incoming or outgoing bulk peptide, for lot acceptance and supplier qualification.
- Target Chemical Profile
- Potency and total peptide mass
- Trifluoroacetate and acetate
- Volatile organic compounds
- Metals and elementals
- Aggregate analysis
- Bacterial endotoxins
Independent verification
Confirmation that material matches its certificate, in a report you can share with your own customers.
- Mass spec identification
- Expanded purity
- Potency or total peptide mass
- Trifluoroacetate and acetate
- Certificate comparison summary
Stability and beyond use dating
A protocol, a stability indicating method, and the timepoint data that justifies your dating claim.
- Real time aging designed to USP <797>
- Storage at recommended conditions
- Six attributes at 30 day intervals
- 120 day study, accelerated available
- Temperature excursion studies
- Final report supporting the dating claim
When there is no monograph
Most peptides in circulation have no USP monograph and no compendial assay. That is not a reason to run a generic gradient and report a number. It is a method development project with a defined path.
Scope the molecule
Sequence, salt form, expected degradation chemistry, and what the data has to support. A peptide with a methionine and a free asparagine has a predictable set of problems.
Develop the separation
Column, gradient, and mobile phase chosen to resolve the parent from the degradants that actually form, not from a hypothetical impurity list.
Prove it is stability indicating
Forced degradation under acid, base, oxidative, thermal, and photolytic stress. If the method cannot see the degradants, it cannot support a shelf life.
Validate and hand it over
Specificity, linearity, accuracy, precision, range, and robustness per ICH Q2, with a validation report and a qualified reference standard you own.
Who we serve
The catalog is the same for everyone. What changes is which results you are required to hold, how often, and what an inspector will ask to see.
503A compounding pharmacies
Patient specific preparations under USP <795> and <797>, where the pressure sits on release timelines and defensible dating.
- Rapid sterility for short dated product
- Endotoxins per batch
- Potency verification on high risk preparations
- Stability studies to extend beyond use dates
503B outsourcing facilities
CGMP expectations layered on compendial testing, with release documentation that has to survive an FDA inspection.
- Full release panels per batch
- Method validation and verification
- Container closure integrity
- Antimicrobial effectiveness for multi dose
API and bulk manufacturers
Lot acceptance and supplier qualification, where the impurity profile decides whether material is usable.
- Target Chemical Profile
- Total peptide mass and counterions
- Volatile organic compounds and metals
- Certificate of analysis verification
Research suppliers and clinics
Independent confirmation for organizations whose reputation depends on their material being what they say it is.
- Mass spec identification
- Purity and potency screening
- Sterility and endotoxins on filled vials
- Third party verification reporting
Submitting samples
First submissions start with a short call. Almost every delay we see is avoidable: not enough material for the panel, a missing formula worksheet, or a suitability study nobody ran.
Tell us the product
Peptide, matrix, container, concentration, and what the data supports: batch release, lot acceptance, a dating study, or a one time check.
Get a quote and a sample plan
Price, turnaround, whether suitability or method development comes first, and exactly how much material each test consumes so you ship the right quantity once. Quotes are valid for 30 days.
Ship with the paperwork
Submission form and formula worksheet in the box. Samples are logged under a unique ID on receipt and we flag anything that arrived outside its shipping conditions.
Review the certificate
Results are reviewed and released as a signed certificate of analysis. An out of specification result comes with a phone call and an investigation, not just a PDF.
What you get back
A result is only worth what its documentation can defend. Every panel produces a package that stands up on its own.
Signed certificate of analysis
Method reference, specification, result, and a clear disposition. No ambiguity about whether a lot passed, and no result reported without the method that produced it named on the page.
Chromatograms and spectra
The underlying data, on request and included by default on characterization work. If you are qualifying a supplier, the trace matters as much as the number.
Out of specification investigation
A failing result triggers a documented investigation into laboratory error before it becomes a product decision, with root cause and a written conclusion you can put in a batch record.
Audit and inspection support
Raw data retained and retrievable. We answer auditor questions about our methods directly rather than routing them back through your quality team.
What the chapters actually require
The most expensive mistakes in compounded peptides come from ordering the wrong test, or ordering the right test without the suitability study that makes the result usable.
Rapid sterility, and how ScanRDI® works
Chapter <1223> sets out how to qualify a microbiological method that is not the compendial one. You demonstrate equivalence or superiority against <71> on specificity, limit of detection, ruggedness, and robustness, and you do it on your own matrix.
ScanRDI® is not a faster incubation. It is solid phase cytometry: sample is filtered onto a membrane, viable cells are labeled with a fluorescent viability substrate, and a laser scans the entire membrane and counts them. Because nothing has to multiply into a visible colony, detection happens at single cell sensitivity in hours rather than days.
The tradeoff is that the qualification package is yours to own. Once it is in place, a sterility result in a few days rather than two weeks changes what dating and distribution look like for a short dated sterile peptide.
USP <71> Sterility Tests
Sets out the compendial procedure you have to follow before a preparation can be called sterile. Product is either filtered through a membrane or inoculated directly into two media, then incubated for 14 days and read for growth.
The test proves absence of growth in the units you sampled. It is not a guarantee for the batch, which is why container closure integrity, environmental monitoring, and process design carry as much weight as the result.
Method suitability, and why a sterility result without it means nothing
Suitability is two separate demonstrations. First, that the growth media recovers specified organisms. Second, that nothing in your formulation inhibits that recovery once product is present. A preserved or intrinsically antimicrobial peptide preparation can suppress growth and hand you a false pass.
It is done once per formulation rather than once per batch, and it has to be on file before a sterility result carries weight. Change the formulation and it repeats.
USP <73> rapid sterility methods
Provides a compendial route for growth based rapid methods that detect microbial ATP rather than waiting for visible turbidity. Validated against the compendial method, it supports the same sterility claim on roughly half the timeline.
USP <85> Bacterial Endotoxins
Endotoxin from gram negative organisms survives sterilization and causes pyrogenic reactions, so any injectable needs a limit and a test. Chapter <85> covers the LAL methods, and we run kinetic chromogenic detection with spike recovery in duplicate.
Every product needs inhibition and enhancement testing to show the formulation does not interfere and to set the maximum valid dilution. Concentrated peptide solutions frequently do interfere.
USP <503> Acetic Acid in Peptides, and the TFA gap
A peptide specific chapter covering determination of acetic acid and acetate, present as counterions from synthesis and purification. Acetate content feeds into your net peptide calculation and, at high levels, into injection tolerability.
There is no equivalent compendial chapter for trifluoroacetate, which is why TFA so often goes unmeasured despite being the more concerning residual. We run it by ion chromatography as a matter of course and help you set an internal specification, since no external one exists to inherit.
USP <51> Antimicrobial Effectiveness
Applies to multi dose containers. Repeated needle entry introduces organisms, so the preparation has to suppress them across its labeled life. The study challenges product with specified organisms and measures log reduction at set intervals over 28 days.
If your peptide preparation has intrinsic antimicrobial activity you may be able to justify a lower preservative level, but only with this data in hand.
USP <621> Chromatography and <1225> validation
Chapter <621> governs how a separation is set up and what system suitability a run has to meet before results are reportable. Chapter <1225>, with ICH Q2, governs proving the method measures what you claim.
A method that has not been shown to resolve the peptide from its degradation products is not stability indicating, and stability data generated with it will not support a beyond use date.
USP <1207> Container Closure Integrity
Demonstrates that the vial and stopper system holds its microbial barrier across the labeled shelf life. We perform dye ingress with UV-Vis spectrophotometric detection, which is widely used for compounded sterile preparations and is the usual companion to a beyond use date study.
Sterility is event related rather than a fixed property, so integrity data is what supports the claim that a unit sitting on a shelf is still sterile.
USP <232> and <233> Elemental Impurities
Chapter <232> sets permitted daily exposure limits by route of administration, and parenteral limits are far tighter than oral. Chapter <233> specifies the analytical procedures and the validation needed to use them.
For peptides the usual sources are catalyst residues, resin and reagent carryover, and leachables from processing equipment.
Questions we get before the first shipment
My peptide has no USP monograph. Can you still test it?
Yes, and most of what we test has no monograph. Either we already have a validated method on file, in which case you get catalog turnaround, or we develop one. Development takes four to six weeks and is quoted before it starts. What we will not do is run a generic gradient and report a purity number that no method supports.
Do I need to supply a reference standard?
If a compendial standard exists we source it. Where none exists we can qualify an in house standard from well characterized material, which becomes the basis for every potency result on that peptide going forward. Potency without a traceable standard is not potency, it is an area count.
What is an acceptable TFA level?
There is no compendial limit for most peptides, which means the specification is yours to set and justify. We report the measured level for both TFA and acetate and help you reason about a limit from route of administration, dose, and the toxicology available. What we will not do is leave it unmeasured because no chapter requires it.
How fast can I actually release sterile product?
Faster than the fourteen days the compendial method needs. Celsis® returns a result in five to seven days, and ScanRDI® is quicker still, with the exact turnaround confirmed when we quote your product. Whichever you choose, method suitability has to be on file first. Plan that study well ahead of your first batch, because it cannot be compressed and nothing releases without it.
Can you support an out of specification investigation or an inspection finding?
Yes. Laboratory error is ruled out first, with documented investigation, and if the result stands we say so plainly. We provide the underlying data and answer auditor questions about our methods directly rather than through your quality team.
Do you test research use only material?
We test material and report what we find. Our certificates state the methods used and the results obtained, and they do not make claims about the regulatory status or intended use of your product. Independent verification is one of our most requested services precisely because that distinction is kept clean.
How should samples be shipped?
Overnight, on cold packs, unless we have told you otherwise for a specific product. Include the submission form and the formula worksheet in the box. We record condition on receipt and will flag an excursion before testing rather than reporting a result that the shipment already compromised.
Request pricing
Tell us the peptide and the panel. We come back with price, turnaround, sample quantity, and whether anything has to happen before routine testing can start.
- info@miraxislabs.com
- Office
- (858) 605-9610
- Laboratory
- 8310 Miramar Mall
San Diego, CA 92121 - Hours
- Monday to Friday, 9am to 6pm Pacific
- Shipping samples
- Overnight on cold packs unless directed otherwise. Include the submission form and formula worksheet.
- Accreditation
- ISO 17025 accredited
- Quotes
- Valid for 30 days. Volume pricing and custom method development available on request.