AssayIndex

AX-2024-004376

Retatrutide · 12 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2404-P8297

MARGINALPURITY ONLY
Report ID
AX-2024-004376
Compound
Retatrutide
Compound class
Incretin analogues and co-agonists
Supplier
QSC — Qingdao Sigma Chemical Co., Ltd.
Batch / lot
QSC-2404-P8297
Declared label claim
12mg
Laboratory
Janoshik Analytical
Assay date
21 Jun 2024
Submitted
24 Jun 2024
Quarter
2024-Q2
Submitter
underfill_3to1
Sample provenance
Supplier-supplied
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, 30 min gradient, 214 nm98.61% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks1.39% area≤ 3.5PASS
Largest single impurityRP-HPLC — incomplete Fmoc removal (+222 Da)0.75% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate6.53%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography9.81%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.76%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 calibration3.872.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient20.67min20.71 ± 0.50 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.860.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²70,248≥ 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.

01541308146226163 Retatrutide20.67 min · 98.61 % 23.0820.23 same trace · ×100 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 30 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 70,248, and skew follows the reported asymmetry factor of 0.86. 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 0.75 % impurity against a 98.61 % 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 peak20.674,792,75298.61
2incomplete Fmoc removal (+222 Da)23.0836,4520.75+222.068
3des-Aib20 analogue20.2319,4410.40-85.053
4[D-Aib2]-diastereomer20.455,8320.120.000
5C18 diacid regioisomer21.252,9160.060.000
6oxidised Trp (+16 Da)20.011,9440.04+15.995
7truncated (5-39)18.759720.02-428.201
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.

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)99.5298.61divergence +0.90 pp vs batch median
Total impurities (% area)not stated1.39
Largest single impurity (% area)not stated0.75
Water (%)5.16.53
Counter-ion (%)5.69.81
Peptide content (%w/w)88.7not determined
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 3 d) → assay. Submitter did not handle the vial.
Assay date
21 Jun 2024
Submitted to the index
24 Jun 2024
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-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 QSC-2404-P8297 n=14

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-004367QSC-2404-P8297Medutest2024-Q298.196.5989.4Supplier-supplied5FAIL
AX-2024-004368QSC-2404-P8297Janoshik2024-Q299.266.87Supplier-supplied3MARGINAL
AX-2024-004369QSC-2404-P8297PeptideMeter2024-Q298.636.18Supplier-supplied3MARGINAL
AX-2024-004370QSC-2404-P8297Medutest2024-Q299.146.45Supplier-supplied3MARGINAL
AX-2024-004371QSC-2404-P8297VendorInvestigate2024-Q298.237.2290.6Buyer-sourced3MARGINAL
AX-2024-004372QSC-2404-P8297VendorInvestigate2024-Q298.785.90Buyer-sourced3MARGINAL
AX-2024-004373QSC-2404-P8297PeptideMeter2024-Q298.206.3595.3Supplier-supplied3MARGINAL
AX-2024-004374QSC-2404-P8297Nordanalyt2024-Q298.276.2491.5Laboratory-retained3MARGINAL
AX-2024-004375QSC-2404-P8297VendorInvestigate2024-Q297.936.09106.6Buyer-sourced3MARGINAL
AX-2024-004377QSC-2404-P8297VendorInvestigate2024-Q298.786.13Buyer-sourced3MARGINAL
AX-2024-004378QSC-2404-P8297Janoshik2024-Q298.446.67100.5Supplier-supplied3MARGINAL
AX-2024-004379QSC-2404-P8297Janoshik2024-Q298.886.27Supplier-supplied3MARGINAL
AX-2024-004380QSC-2404-P8297Medutest2024-Q298.676.27Supplier-supplied3MARGINAL
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 QSC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041683CJC-1295 (no DAC)QSC-2606-V8637Janoshik2026-Q399.933.6397.1Supplier-supplied1FAIL
AX-2026-041727CJC-1295 with DACQSC-2602-E9474Janoshik2026-Q398.886.62105.3Supplier-supplied1MARGINAL
AX-2026-041728CJC-1295 with DACQSC-2602-E9474VendorInvestigate2026-Q398.427.04Buyer-sourced1MARGINAL
AX-2026-041734CJC-1295 with DACQSC-2602-E9474Medutest2026-Q399.437.17105.5Supplier-supplied2FAIL
AX-2026-041652LiraglutideQSC-2605-W8602Nordanalyt2026-Q399.336.55Supplier-supplied0PASS
AX-2026-041730CJC-1295 with DACQSC-2602-E9474PeptideMeter2026-Q398.796.9395.4Supplier-supplied1MARGINAL
AX-2026-041686CJC-1295 (no DAC)QSC-2606-V8637Janoshik2026-Q399.934.04Supplier-supplied0PASS
AX-2026-041653LiraglutideQSC-2605-W8602VendorInvestigate2026-Q398.825.95Buyer-sourced0PASS