AssayIndex

AX-2026-043164

Retatrutide · 10 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2601-T7702

MARGINALPURITY ONLY
Report ID
AX-2026-043164
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Batch / lot
SSA-2601-T7702
Declared label claim
10mg
Laboratory
Medutest
Assay date
21 Feb 2026
Submitted
13 Mar 2026
Quarter
2026-Q1
Submitter
j.ogunleye
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, 25 min gradient, 214 nm97.76% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks2.24% area≤ 3.5PASS
Largest single impurityRP-HPLC — oxidised Trp (+16 Da)1.59% area≤ 1.00FAIL
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance84.99%w/wNOT TESTED
Target-compound contenttotal peptide content × purity83.09%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen12.92mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content10.735mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim107.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.11%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography8.53%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.37%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 cake, partial shrinkage from vial wallwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear after 90 s gentle swirling, no particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.362.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient17.43min17.53 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.940.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²71,587≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib2]-diastereomer0.69no 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.

01791358253737164 Retatrutide17.43 min · 97.76 % 16.8819.44 same trace · ×20 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 25 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 71,587, and skew follows the reported asymmetry factor of 0.94. 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 1.59 % impurity against a 97.76 % 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 peak17.434,751,43997.76
2oxidised Trp (+16 Da)16.8877,2791.59+15.995
3[D-Aib2]-diastereomer17.2520,4130.420.000
4truncated (5-39)15.836,3180.13-428.201
5incomplete Fmoc removal (+222 Da)19.443,4020.07+222.068
6C18 diacid regioisomer17.919720.020.000
7des-Aib20 analogue17.064860.01-85.053
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 Fischer6.11
Counter-ion (TFA)ion chromatography8.53
Residual solvent + inorganic residueestimated0.37
Total peptide contentby difference84.99
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)99.2097.76divergence +0.40 pp vs batch median
Total impurities (% area)0.802.24
Largest single impurity (% area)0.471.59
Water (%)not stated6.11
Counter-ion (%)8.98.53
Peptide content (%w/w)87.084.99
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNOno method section — the result cannot be reconciled against any other
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
Retail purchase → submitter (−20 °C, 33 d) → laboratory (courier, dry ice, 4 d) → assay.
Assay date
21 Feb 2026
Submitted to the index
13 Mar 2026
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
PURITY ONLY
Section 6

Annotations

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot SSA-2601-T7702 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043158SSA-2601-T7702Medutest2026-Q198.965.0796.2Supplier-supplied2MARGINAL
AX-2026-043159SSA-2601-T7702Janoshik2026-Q198.755.3891.6Supplier-supplied2MARGINAL
AX-2026-043160SSA-2601-T7702Nordanalyt2026-Q199.045.37Supplier-supplied2MARGINAL
AX-2026-043161SSA-2601-T7702Janoshik2026-Q198.694.7290.9Supplier-supplied2MARGINAL
AX-2026-043162SSA-2601-T7702Medutest2026-Q198.705.82106.4Supplier-supplied3FAIL
AX-2026-043163SSA-2601-T7702Medutest2026-Q198.905.14Supplier-supplied2MARGINAL
AX-2026-043165SSA-2601-T7702Medutest2026-Q198.854.89105.4Supplier-supplied2MARGINAL
Other recent Retatrutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043029KPKP-2607-H5219Medutest2026-Q395.455.71Supplier-supplied2FAIL
AX-2026-043030KPKP-2607-H5219Kestrel2026-Q395.976.9597.1Supplier-supplied2FAIL
AX-2026-041453QYBQYB-2604-B5660VendorInvestigate2026-Q398.022.55Buyer-sourced1MARGINAL
AX-2026-041454QYBQYB-2604-B5660Janoshik2026-Q398.842.77Supplier-supplied1MARGINAL
AX-2026-041538QYBQYB-2602-G6308Medutest2026-Q398.502.85Supplier-supplied2MARGINAL
AX-2026-041456QYBQYB-2604-B5660Janoshik2026-Q398.233.24Supplier-supplied1MARGINAL
AX-2026-041452QYBQYB-2604-B5660Nordanalyt2026-Q398.503.36Supplier-supplied1MARGINAL
AX-2026-043039KPKP-2607-H5219Janoshik2026-Q396.145.62Supplier-supplied2FAIL
Other recent SSA records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043144GHK-CuSSA-2604-V7620Janoshik2026-Q298.355.25105.8Supplier-supplied0PASS
AX-2026-043141SemaxSSA-2604-L7628Kestrel2026-Q298.848.5893.2Supplier-supplied2MARGINAL
AX-2026-043117MazdutideSSA-2605-G6781Janoshik2026-Q299.233.6790.4Supplier-supplied1MARGINAL
AX-2026-043136BPC-157SSA-2601-N6752Janoshik2026-Q297.754.32Supplier-supplied2FAIL
AX-2026-043118MazdutideSSA-2605-G6781Medutest2026-Q298.292.6588.7Buyer-sourced2MARGINAL
AX-2026-043138BPC-157SSA-2601-N6752Janoshik2026-Q298.004.30101.0Supplier-supplied1MARGINAL
AX-2026-043137BPC-157SSA-2601-N6752Janoshik2026-Q297.414.36104.5Laboratory-retained1FAIL
AX-2026-043146Enclomiphene citrateSSA-2603-C6950Medutest2026-Q297.923.1192.9Buyer-sourced2FAIL