Analytical Methods · Lot Data First

Methods selected for the molecule and agreed specification.

Ask sales for the batch-specific COA corresponding to the offered or shipped lot. It identifies the tests performed, applicable specifications, and results; expanded analytical work is scoped when the project requires it.

Lyochem lot release bench — lyophilised research-peptide vials photographed under the analytical-lab inspection lamp; every vial label corresponds to a lot-specific RP-HPLC chromatogram and ESI-MS identity confirmation.

Lot Report · Excerpt

TB-500 · Lot LC-26-B0312

Released

RP-HPLC purity: 98.94 %
ESI-MS [M+H]⁺: 4961.4 Da
MS/MS sequence: Confirmed
Water (KF): 5.2 %
Counter-ion: Acetate
Stability (12 mo): ≥ 97 % retained

Reference the COA matched to the supplied lot in your supplementary materials and supplier-qualification file. The reported panel follows that lot's applicable specification.

Illustrative lot report excerpt · TB-500 lot LC-26-B0312 · representative format only; ask sales for the applicable batch COA

Quality you can verify

Lot data first. Sales second.

Ask sales for the COA matched to the offered or supplied lot. It records the tests actually completed, their specifications, and the reported results. Expanded methods, raw data, or an independent-laboratory report must be agreed before quotation.

LOT

COA matched by batch

SCOPE

Methods agreed up front

EXTRA

Quoted when required

RP-HPLC + ESI-MS recorded on the batch COA when included in the applicable release specification.

LC-MS/MS sequence on request — b- and y-ion ladder assignment against the theoretical sequence; full-ladder coverage reported on the data packet.

−20 °C stability programme available when a written project scope requires stability evidence and capability, timing, and cost are agreed.

View a sample data packet (PDF)Inside the analytical programme

Third-party analytical reports

Professional third-party testing in Tianjin, matched by product.

Independent HPLC and mass-spectrometry reports from Qorix , the professional, authoritative third-party analytical laboratory at tjqxgd.com, affiliated with the Tianjin International Joint Academy of Biomedicine.

Preview reports for eight of the most-requested matched products.

View all 22 reports

Third-party testView report record →

Retatrutide

50 mg · HPLC / MS

RT50-20260814S6492

Third-party testView report record →

BPC-157

10 mg · HPLC / MS

BC10-20260806S9397

Third-party testView report record →

TB-500 / Thymosin beta-4

10 mg · HPLC / MS

TB10-20260810S7175

Third-party testView report record →

MOTS-C

10 mg · HPLC / MS

MS10-20260810S6595

Third-party testView report record →

CJC-1295 + Ipamorelin

5 + 5 mg · HPLC / MS

CJCIPA510-20260814S6492

Third-party testView report record →

Epithalon

50 mg · HPLC / MS

EPI50-20260814S6492

Third-party testView report record →

SS-31

50 mg · HPLC / MS

SS50-20260806S9397

KPV independent HPLC and MS report KP10-20260810S6595 first-page preview

Third-party testView report record →

KPV

10 mg · HPLC / MS

KP10-20260810S6595

Complete and current documentation

Need a complete, clear Batch COA or third-party report?

Send us the product and document type. Sales will confirm the applicable lot, batch, or report number and provide the latest available full-resolution document.

Request a COA or report

Analytical method library

What a Lyochem analytical scope can include.

The appropriate panel depends on the molecule and the specification agreed for the project. The batch COA records the methods actually used, numerical results, and the release decision for the lot. Method provenance may reference USP <621>, USP <1225>, ICH Q2, or EP equivalents when applicable.

Test	Method	Target	Why we run it
RP-HPLC purity	C18 gradient, 214 nm + 280 nm; USP <621> + ICH Q2 aligned	≥ 99 %	Resolves the synthesised peptide from synthesis truncations and late-eluting impurities. The purity number on the lot report is the integrated area % of the main peak; the chromatogram itself is attached to the lot packet.
ESI-MS identity	ESI-MS, monoisotopic [M+H]⁺ vs. theoretical	Confirmed (±0.5 Da)	Confirms the synthesised molecule has the expected molecular weight. Mass alone is necessary but not sufficient (see MS/MS row).
Sequence verification	LC-MS/MS, full b/y-ion ladder for peptides > 5 aa	Sequence confirmed	Directly demonstrates the synthesised sequence matches the labelled sequence. Rules out same-mass truncation-plus-elongation by-products that ESI-MS alone cannot distinguish.
Water content (KF)	Coulometric Karl Fischer	≤ 8.0 %	Lyophilisation-cycle control. Out-of-band water accelerates degradation kinetics during −20 °C storage and is the most common cause of unexpected potency drift at re-test.
Counter-ion	Ion chromatography	Acetate (default) or TFA (specified)	Acetate is the default salt form because residual TFA can suppress observed potency in cell-based bioassays. TFA salt is available when explicitly requested.
Residual solvents	GC headspace	ICH Q3C limits	Catches residuals from the SPPS cleavage, lyophilisation, and purification steps. Relevant for any peptide active going into a downstream bioassay.

Stability programme

What 12 months of stability data look like.

Stability evidence is product- and lot-specific. Ask sales which timepoints are available for the lot under discussion; accelerated and solution-stability work can be added to the agreed scope for projects that hold material outside the standard cold chain or pre-prepare working stocks.

Test	Method	Target	Why we run it
Lyophilised stability (−20 °C)	Example scope: time-course RP-HPLC and/or ESI-MS through 12 months	Defined in the agreed protocol	May be scoped to study practical stability under agreed storage conditions. Confirm method, timepoints, acceptance criteria, report format, timing, and cost with sales.
Accelerated stability (40 °C / 75 %RH)	Time-course RP-HPLC through 1 / 3 / 6 months	Documented decay rate	Predicts the practical shelf-life for buyers whose workflow holds the active outside cold chain (e.g. lab benches, cross-border shipping). On request.
Solution stability	Time-course at reconstitution + 24 / 48 / 72 h in BAC water / PBS	Documented	For buyers who pre-prepare working stocks. Most peptide degradation in research workflows comes from solution-phase handling, not the lyophilised storage.

In vivo add-ons

Endotoxin + microbial limits, on request.

LAL bacterial endotoxin, USP <61>/<62> microbial limits, and granular bioburden testing are not part of the default in vitro release scope — they add 3–5 business days of QC turnaround and are not needed for the bench- scale workflows most academic and CRO buyers run. For in vivo research, however, they are usually a precondition rather than a nice-to-have.

Specify in vivo intent at the inquiry stage and the lot is flagged for the additional release testing; the COA then carries chemical-purity, sequence-verification, and biological-safety data on a single document, which simplifies IACUC and IRB record-keeping.

Test	Method	Target	Why we run it
Bacterial endotoxin (LAL)	Gel-clot or kinetic chromogenic per USP <85>	< 0.25 EU/mg (or as specified)	Relevant when an in vivo protocol requires it: endotoxin contamination can activate NF-κB reporters, macrophage panels, and neutrophil-priming assays. Include the method in the agreed scope before quotation rather than assuming it is part of every COA.
Microbial limits	USP <61>/<62>	Compliant	Bioburden control for in vivo or cell-based assay workflows where microbial contamination would confound the readout independently of endotoxin.
Bioburden	Membrane filtration + plate count	Documented CFU/mg	Granular bioburden data for IACUC / IRB record-keeping when the protocol commits to a numerical bioburden ceiling rather than a USP-pass/fail.

Lot report contents

What lands on your bench.

Ask sales for the COA matched to the offered or supplied lot. Supporting raw analytics — such as an RP-HPLC chromatogram, ESI mass spectrum, MS/MS sequence ladder, or stability time-series — are provided only when available for that lot or included in an agreed project scope.

RP-HPLC chromatogram

Peak-integration trace with retention times and integrated areas; the document you cite in supplementary materials.

ESI-MS identity

[M+H]⁺ vs. theoretical with the residual mass error in Da. Confirms molecular weight to ±0.5 Da.

LC-MS/MS sequence ladder

Full b/y-ion ladder for peptides above 5 amino acids. Directly demonstrates synthesised sequence.

Water content (KF)

Coulometric Karl Fischer titration. Lyophilisation-cycle control.

Counter-ion

Acetate by default; TFA on request. Affects solubility, stability, and downstream bioassay readouts.

Stability time-course

−20 °C 12-month lyophilised; accelerated 40 °C and solution-phase on request.

Request a data packet.

First reply under 24 hours from a synthesis chemist or analytical contact — not a templated auto-response. Ask sales for the matching batch COA and confirm which chromatograms, spectra, sequence work, water, or stability data are available or need separate scoping.

Lot data first. Sales second.

LOT

COA matched by batch

SCOPE

Methods agreed up front

EXTRA

Quoted when required

RP-HPLC + ESI-MS recorded on the batch COA when included in the applicable release specification.

LC-MS/MS sequence on request — b- and y-ion ladder assignment against the theoretical sequence; full-ladder coverage reported on the data packet.

−20 °C stability programme available when a written project scope requires stability evidence and capability, timing, and cost are agreed.

Test

Method

Target

RP-HPLC purity

C18 gradient, 214 nm + 280 nm; USP <621> + ICH Q2 aligned

≥ 99 %

ESI-MS identity

ESI-MS, monoisotopic [M+H]⁺ vs. theoretical

Confirmed (±0.5 Da)

Sequence verification

LC-MS/MS, full b/y-ion ladder for peptides > 5 aa

Sequence confirmed

Water content (KF)

Coulometric Karl Fischer

≤ 8.0 %

Counter-ion

Ion chromatography

Acetate (default) or TFA (specified)

Residual solvents

GC headspace

ICH Q3C limits

Test

Method

Target

Lyophilised stability (−20 °C)

Example scope: time-course RP-HPLC and/or ESI-MS through 12 months

Defined in the agreed protocol

Accelerated stability (40 °C / 75 %RH)

Time-course RP-HPLC through 1 / 3 / 6 months

Documented decay rate

Solution stability

Time-course at reconstitution + 24 / 48 / 72 h in BAC water / PBS

Documented

Test

Method

Target

Bacterial endotoxin (LAL)

Gel-clot or kinetic chromogenic per USP <85>

< 0.25 EU/mg (or as specified)

Microbial limits

USP <61>/<62>

Compliant

Bioburden

Membrane filtration + plate count

Documented CFU/mg