Testing
Three matrices, one reporting standard. Peptides are the primary scope; supplements and cosmetic actives are the same determinations applied to harder sample matrices.
| Panel | USD |
|---|---|
| Identity and purity | 341 |
| Content | 525 |
| Parenteral safety | 1025 |
| Full characterisation | 1730 |
Every panel begins with identity, because everything downstream is conditional on it. An endotoxin figure for a vial containing the wrong compound is a correct measurement of an irrelevant thing. Identity, then purity, then content, then the safety determinations that the route of administration actually requires.
Research peptides
Identity, purity, content and parenteral safety for synthetic peptides
02Dietary supplements
Label verification, active content, elemental impurities and microbial quality
03Cosmetic actives
Active concentration, preservative efficacy inputs, metals and microbiological quality
04Androgen receptor modulators
Identity, chromatographic purity, enantiomeric purity and content for non-steroidal small molecules
| Form | Amount | Why |
|---|---|---|
| Finished vial, lyophilised | One unopened vial | Unopened, so that seal integrity and cake appearance can be assessed on receipt. |
| Raw API powder | 30 mg, sealed glass vial | Glass, not plastic. Powder that has taken up water reports low on every mass-derived figure. |
| Solution | 1 mL | Two millilitres where endotoxin determination is requested. |
| Microbial enumeration or sterility | Two unopened units | An opened container cannot be distinguished from one contaminated in transit. |
| Tablet or capsule | One unit per determination | Content uniformity requires ten units from a single batch. |
| Finished cosmetic | 50 g or two retail units | Preservative efficacy testing consumes 150 g and takes 28 days. |
Two rules that decide whether a result is worth anything
Send unopened units for microbiological work. An opened container cannot be distinguished from one contaminated in transit, so a count from it describes handling rather than the product.
Send raw powder in sealed glass. Lyophilised peptide takes up atmospheric water within minutes. Powder shipped in plastic arrives heavier than it left, and every mass-derived figure then reports low.
Batch variance requires at least three units from a single batch. Units from different batches answer a different question and are reported separately.
Endotoxin determination is not offered on oils, raw API powder, tablets or capsules. The assay is validated for aqueous injectable matrices, and results from the others would be interference rather than measurement.
Sterility testing is not recommended for oral dosage forms, which are not required to be sterile and for which a sterility result carries no information. Microbial enumeration under USP <61> is the correct determination there.
Untargeted gas chromatographic screening cannot be run on peptides, because the technique requires volatile or semi-volatile analytes. Untargeted LC-MS screening for peptide contamination is bounded by the reference standards held, and that boundary is stated on the certificate rather than left implied.
No compound is analysed without a reference standard. Where one is not held, the analysis is declined rather than approximated.
| Endotoxin on oils, raws, orals | Matrix outside assay validity |
| Sterility on oral forms | Result carries no information |
| GC-MS on peptides | Analytes not volatile |
| Compounds without a standard | Identity and content not determinable |
| Clinical or diagnostic samples | Outside scope entirely |
Turnaround is confirmed with the quotation. Microbiological determinations are governed by incubation and cannot be shortened.
Every determination on this site is named after the compendial chapter it was actually run under, and reported against that chapter's requirements. A result labelled with the wrong chapter is the most common way a certificate misleads without containing a false number.
Microbiological quality
- USP <61> Microbial enumeration tests
- USP <62> Tests for specified micro-organisms
- USP <71> Sterility tests
Enumeration and sterility are different tests with different facilities and different answers. Each is named after the chapter it was run under, never after the other.
Pyrogens and endotoxins
Endotoxin survives autoclaving and passes a sterilising filter, so a sterile preparation can still be pyrogenic. Reported quantitatively in endotoxin units, with the inhibition and enhancement check.
Elemental impurities
- USP <232> Elemental impurities, limits
- USP <233> Elemental impurities, procedures
- ICH Q3D(R2) Guideline for elemental impurities
Quantified at parts per billion against permitted daily exposures, element by element, with the digestion recovery reported.
Residual solvents
Targeted headspace panel against class limits. Class 1 solvents are reported against their individual concentration limits rather than a summed figure.
Composition and mass balance
- USP <921> Water determination
- USP <461> Nitrogen determination
- ICH Q6A Specifications for new chemical substances
- ICH Q6B Specifications for biotechnological products
The determinations that convert a purity percentage into milligrams by accounting for what the ultraviolet trace never sees.
Method validation
- ICH Q2(R2) Validation of analytical procedures
- USP <1058> Analytical instrument qualification
- ICH Q3A(R2) Impurities in new drug substances
A number without a validated method behind it is an opinion with a decimal point. Detection and quantitation limits are established per analyte and per matrix.
These are the standards the determinations are performed and reported under. They are not a claim of accreditation to them. Where a determination falls inside a scope of accreditation, the certificate states which determinations do and which do not, because accreditation attaches to a method applied to a matrix and never to a laboratory in general.
What can ANALYTON test besides peptides?
Dietary supplements for label claim, content uniformity, elemental impurities and microbial quality, and cosmetic actives for concentration in the finished formulation, microbiological quality and preservative efficacy. Peptides remain the primary matrix.
Why are panels cumulative?
Because a safety figure on material of unverified identity is a correct measurement of an irrelevant thing. Identity comes first, then purity and content, then the safety determinations.
What is not tested?
Endotoxin on oils, raw powders, tablets and capsules, because the assay is validated for aqueous injectable matrices. Sterility on oral forms, where the result carries no information. Any compound for which no reference standard is held. Clinical and diagnostic specimens are outside scope entirely.
Updated 2026-09-01