AssayIndex

AX-2026-041901

Semaglutide · 2 mg declared · SinoPep Biotechnology (Changzhou) Co., Ltd. · lot SNP-2509-A4337

PASSVERIFIED
Report ID
AX-2026-041901
Compound
Semaglutide
Compound class
Incretin analogues and co-agonists
Supplier
SinoPep — SinoPep Biotechnology (Changzhou) Co., Ltd.
Batch / lot
SNP-2509-A4337
Declared label claim
2mg
Laboratory
Janoshik Analytical
Assay date
05 Jan 2026
Submitted
11 Jan 2026
Quarter
2026-Q1
Submitter
Contributor #E-3392
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, 30 min gradient, 214 nm98.59% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.41% area≤ 3.0PASS
Largest single impurityRP-HPLC — tBu-protected residual (+56 Da)0.88% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula4111.0524DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4111.0142DaNOT TESTED
Mass accuracyobserved vs theoretical-9.3ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate5.42%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography8.84%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.87%NOT TESTED
Endotoxinkinetic chromogenic LAL0.43EU/mg≤ 5.0PASS
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 with a single visible fibreclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.002.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient18.32min18.42 ± 0.45 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.180.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²80,404≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib8]-diastereomer0.91no 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.

01621324148626482 Semaglutide18.32 min · 98.59 % 20.3717.50 same trace · ×50 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 80,404, and skew follows the reported asymmetry factor of 1.18. 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 0.88 % impurity against a 98.59 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Semaglutide — main peak18.324,791,78098.59
2tBu-protected residual (+56 Da)20.3742,7710.88+56.063
3des-AEEA semaglutide (−145 Da)17.5012,1510.25-145.074
4semaglutide dimer22.038,7490.18+4111.052
5[D-Aib8]-diastereomer18.083,4020.070.000
6deamidated (Asn→Asp, +1 Da)17.819720.02+0.984
7des-His1 truncate (−137 Da)17.184860.01-137.059
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 3

Mass spectrum and identity

Theoretical monoisotopic mass 4111.0524 Da, computed from C187H291N45O59. All ppm figures on this site are against monoisotopic values — see why that matters.

02550751005008001100140017002000 [M+4H]4+1028.76[M+3H]3+1371.35[M+5H]5+823.21 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 4111.0142 Da. Sodium (+21.982/z) and potassium (+37.956/z) adducts are shown where the parent charge state exceeds 25 % relative abundance; they are adducts of the same molecule and are not impurities.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
6+686.1827686.1763-0.00648.4
5+823.2178823.2101-0.007749.5
4+1028.77041028.7608-0.0096100.0
3+1371.35811371.3453-0.012851.8
2+2056.53352056.5144-0.01918.5
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)98.8998.59divergence +0.32 pp vs batch median
Total impurities (% area)not stated1.41
Largest single impurity (% area)not stated0.88
Water (%)not stated5.42
Counter-ion (%)9.38.84
Peptide content (%w/w)86.6not determined
Endotoxin (EU/mg)not stated0.43
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
Domestic warehouse despatch → submitter (2–8 °C, 3 d) → laboratory (courier, cold pack, 10 d) → assay.
Assay date
05 Jan 2026
Submitted to the index
11 Jan 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
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.

price_per_mg
A retail purchase carries a price, which makes cost per milligram of recovered peptide computable. That is the comparison a buyer actually needs and it exists only for this provenance class.
Section 7

Related records

Same batch — lot SNP-2509-A4337 n=6

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041900SNP-2509-A4337PeptideMeter2026-Q198.705.26Buyer-sourced0PASS
AX-2026-041902SNP-2509-A4337PeptideMeter2026-Q198.455.04Buyer-sourced0PASS
AX-2026-041903SNP-2509-A4337Janoshik2026-Q198.705.33Buyer-sourced0PASS
AX-2026-041904SNP-2509-A4337Nordanalyt2026-Q198.554.69104.6Buyer-sourced0PASS
AX-2026-041905SNP-2509-A4337Janoshik2026-Q198.545.42100.1Buyer-sourced0PASS
Other recent Semaglutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043376WXTWXT-2604-C3248Janoshik2026-Q397.084.22Buyer-sourced1MARGINAL
AX-2026-042424HomopeptideHOMO-2604-X3806PeptideMeter2026-Q398.854.8792.0Buyer-sourced0PASS
AX-2026-041643FGPFGP-2602-M8547Janoshik2026-Q399.312.79100.7Buyer-sourced0PASS
AX-2026-041334WWBWWB-2606-N3192Janoshik2026-Q398.934.6299.9Buyer-sourced0PASS
AX-2026-042002AMBAMB-2607-N6274VendorInvestigate2026-Q398.236.3797.1Buyer-sourced1MARGINAL
AX-2026-041337WWBWWB-2606-N3192Nordanalyt2026-Q399.523.92Buyer-sourced0PASS
AX-2026-042595HJHJ-2608-C7002Janoshik2026-Q399.503.55Buyer-sourced1MARGINAL
AX-2026-042217TFCTFC-2604-X9037PeptideMeter2026-Q398.954.6196.9Buyer-sourced0PASS
Other recent SinoPep records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041867CJC-1295 with DACSNP-2607-C3886Janoshik2026-Q399.245.12Laboratory-retained1FAIL
AX-2026-041913IpamorelinSNP-2606-L4478PeptideMeter2026-Q398.885.28Buyer-sourced0FAIL
AX-2026-041914IpamorelinSNP-2606-L4478Janoshik2026-Q399.145.49Buyer-sourced0PASS
AX-2026-041909IpamorelinSNP-2606-L4478PeptideMeter2026-Q399.005.4889.5Buyer-sourced1MARGINAL
AX-2026-041895IpamorelinSNP-2602-B3833Janoshik2026-Q399.934.72105.9Buyer-sourced1MARGINAL
AX-2026-041930IGF-1 LR3SNP-2606-D4620Medutest2026-Q398.545.3793.8Buyer-sourced0PASS
AX-2026-041898IpamorelinSNP-2602-B3833Nordanalyt2026-Q399.934.5496.0Buyer-sourced1MARGINAL
AX-2026-041931IGF-1 LR3SNP-2606-D4620PeptideMeter2026-Q397.935.1993.4Buyer-sourced0PASS