AssayIndex

AX-2025-021104

Retatrutide · 5 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2412-Y5177

PASSPURITY ONLY
Report ID
AX-2025-021104
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot
BCH-2412-Y5177
Declared label claim
5mg
Laboratory
PeptideMeter
Assay date
04 Jun 2025
Submitted
26 Jun 2025
Quarter
2025-Q2
Submitter
v.balogun
Sample provenance
Buyer-sourced
Section 1

Results

Measured against the index acceptance specification for the incretin analogues and co-agonists class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 28 min gradient, 214 nm96.81% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks3.19% area≤ 3.5PASS
Largest single impurityRP-HPLC — C18 diacid regioisomer1.63% area≤ 1.00FAIL
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance86.05%w/wNOT TESTED
Target-compound contenttotal peptide content × purity83.31%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen6.27mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content5.224mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim104.5%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.75%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography9.72%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.48%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.102.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient19.49min19.44 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.250.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²26,587≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.42no index criterionREPORTED
Section 2

Chromatogram and peak integration

The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.

0834166825013335 Retatrutide19.49 min · 96.81 % 20.0321.7417.70 same trace · ×20 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 26,587, and skew follows the reported asymmetry factor of 1.25. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 1.63 % impurity against a 96.81 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Retatrutide — main peak19.494,705,26696.81
2C18 diacid regioisomer20.0379,2231.630.000
3des-Aib20 analogue19.0835,9660.74-85.053
4incomplete Fmoc removal (+222 Da)21.7416,5250.34+222.068
5truncated (5-39)17.7012,6370.26-428.201
6oxidised Trp (+16 Da)18.876,8040.14+15.995
7[D-Aib2]-diastereomer19.283,8880.080.000
Closure check — purity + Σ impurities 100.00CLOSES

Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.

Section 4

Gravimetric mass balance

Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.

ComponentDetermination%w/w of cake
WaterKarl Fischer3.75
Counter-ion (TFA)ion chromatography9.72
Residual solvent + inorganic residueestimated0.48
Total peptide contentby difference86.05
Total100.00 CLOSES

Supplier certificate, as declared

The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.

FigureSupplier COAThis reportIndex note
Purity (% area)97.1696.81divergence +0.14 pp vs batch median
Total impurities (% area)2.843.19
Largest single impurity (% area)1.421.63
Water (%)not stated3.75
Counter-ion (%)7.59.72
Peptide content (%w/w)88.486.05
Endotoxin (EU/mg)not statednot determined
Method stated on certificateYEScolumn, gradient and wavelength given
Section 5

Provenance and caveats

Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.

Sample provenance
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Domestic warehouse despatch → submitter (2–8 °C, 31 d) → laboratory (courier, cold pack, 6 d) → assay.
Assay date
04 Jun 2025
Submitted to the index
26 Jun 2025
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 min gradient · high-resolution MS
Verification status
PURITY ONLY
Section 6

Annotations 1

Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.

c18_2p6
Core-shell packing at 2.6 µm gains roughly 40 % in resolution over a 5 µm fully porous bed at the same length and pressure. On a pair this close, that is the difference between two peaks and one.
Section 7

Related records

Same batch — lot BCH-2412-Y5177 n=3

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-021103BCH-2412-Y5177Kestrel2025-Q298.343.49106.8Buyer-sourced0PASS
AX-2025-021105BCH-2412-Y5177PeptideMeter2025-Q297.024.01102.7Buyer-sourced0PASS
Other recent Retatrutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042437HomopeptideHOMO-2605-V4718Nordanalyt2026-Q398.683.67102.8Buyer-sourced0PASS
AX-2026-043095KPKP-2607-H5774Janoshik2026-Q395.815.48105.2Buyer-sourced0FAIL
AX-2026-042282TFCTFC-2608-J1156Janoshik2026-Q398.544.27Buyer-sourced0PASS
AX-2026-043094KPKP-2607-H5774PeptideMeter2026-Q396.326.40Buyer-sourced0FAIL
AX-2026-042441HomopeptideHOMO-2605-V4718Medutest2026-Q398.934.22Buyer-sourced0PASS
AX-2026-041427QYBQYB-2604-B4920PeptideMeter2026-Q397.932.45101.7Buyer-sourced0PASS
AX-2026-041786ASYASY-{CAT}-2288VendorInvestigate2026-Q398.786.59Buyer-sourced0PASS
AX-2026-041428QYBQYB-2604-B4920Janoshik2026-Q398.353.20Laboratory-retained0PASS
Other recent BCH records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043445BPC-157BCH-2603-G4350Nordanalyt2026-Q398.424.8793.6Buyer-sourced1MARGINAL
AX-2026-043440BPC-157BCH-2603-G4350VendorInvestigate2026-Q398.614.11Buyer-sourced1MARGINAL
AX-2026-043442BPC-157BCH-2603-G4350Janoshik2026-Q398.654.78Buyer-sourced1MARGINAL
AX-2026-043471CJC-1295 with DACBCH-2607-H5235Janoshik2026-Q397.465.48Buyer-sourced1FAIL
AX-2026-043477CJC-1295 with DACBCH-2607-H5235VendorInvestigate2026-Q397.625.3299.6Buyer-sourced1MARGINAL
AX-2026-043449BPC-157BCH-2603-G4350Kestrel2026-Q399.744.9291.3Supplier-supplied2MARGINAL
AX-2026-043448BPC-157BCH-2603-G4350Janoshik2026-Q398.554.69106.9Buyer-sourced1MARGINAL
AX-2026-043470CJC-1295 with DACBCH-2607-H5235Janoshik2026-Q397.766.1199.3Supplier-supplied1MARGINAL