AssayIndex

AX-2025-021280

Semaglutide · 10 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2505-Y7460

MARGINALVERIFIED
Report ID
AX-2025-021280
Compound
Semaglutide
Compound class
Incretin analogues and co-agonists
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot
BCH-2505-Y7460
Declared label claim
10mg
Laboratory
Janoshik Analytical
Assay date
12 Dec 2025
Submitted
31 Dec 2025
Quarter
2025-Q4
Submitter
d.karlsen
Sample provenance
Laboratory-retained
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 nm97.84% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks2.16% area≤ 3.0PASS
Largest single impurityRP-HPLC — [D-Aib8]-diastereomer1.28% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula4111.0524Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)4111.0483Da—NOT TESTED
Mass accuracyobserved vs theoretical-1.0ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance84.19%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity82.37%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen11.26mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.275mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim92.8%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.64%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography8.63%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.54%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.25EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 d—no growthPASS
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureFaint haze, clearing on standing—clear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.21—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient18.44min18.42 ± 0.45 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.13—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²42,735—≥ 20,000PASS
Resolution to nearest impurityvs [D-Aib8]-diastereomer0.66—no 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.

01193238635794772 Semaglutide18.44 min · 97.84 % 18.2022.15 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 42,735, and skew follows the reported asymmetry factor of 1.13. 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 1.28 % impurity against a 97.84 % 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 peak18.444,755,32797.84—
2[D-Aib8]-diastereomer18.2062,2121.280.000
3C18 diacid mono-ester19.8023,8160.49+14.016
4des-AEEA semaglutide (−145 Da)17.6210,6930.22-145.074
5semaglutide dimer22.155,3460.11+4111.052
6deamidated (Asn→Asp, +1 Da)17.931,9440.04+0.984
7des-His1 truncate (−137 Da)17.309720.02-137.059
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+1028.77[M+5H]5+823.22[M+3H]3+1371.36 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 4111.0483 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+686.1827686.1820-0.00077.8
5+823.2178823.2169-0.000954.3
4+1028.77041028.7694-0.0010100.0
3+1371.35811371.3567-0.001452.5
2+2056.53352056.5314-0.00218.0
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 Fischer6.64
Counter-ion (TFA)ion chromatography8.63
Residual solvent + inorganic residueestimated0.54
Total peptide contentby difference84.19
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)98.2897.84divergence +0.07 pp vs batch median
Total impurities (% area)not stated2.16
Largest single impurity (% area)not stated1.28
Water (%)4.86.64
Counter-ion (%)2.78.63
Peptide content (%w/w)91.984.19
Endotoxin (EU/mg)not stated0.25
Method stated on certificateYES—column, 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
Laboratory-retained
Evidentiary weight
Provenance documented, selection uncontrolled.
Chain of custody
Laboratory retained sample (−20 °C, 1 d since original receipt) → re-assay.
Assay date
12 Dec 2025
Submitted to the index
31 Dec 2025
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
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 BCH-2505-Y7460 n=10

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-021272BCH-2505-Y7460Medutest2025-Q498.296.78—Supplier-supplied1MARGINAL
AX-2025-021273BCH-2505-Y7460VendorInvestigate2025-Q497.446.44—Buyer-sourced1MARGINAL
AX-2025-021274BCH-2505-Y7460Janoshik2025-Q498.216.41—Supplier-supplied1MARGINAL
AX-2025-021275BCH-2505-Y7460Nordanalyt2025-Q497.946.40—Supplier-supplied1MARGINAL
AX-2025-021276BCH-2505-Y7460Kestrel2025-Q498.986.10—Laboratory-retained1MARGINAL
AX-2025-021277BCH-2505-Y7460Kestrel2025-Q498.825.8588.7Buyer-sourced2MARGINAL
AX-2025-021278BCH-2505-Y7460Nordanalyt2025-Q497.775.7195.5Supplier-supplied1MARGINAL
AX-2025-021279BCH-2505-Y7460PeptideMeter2025-Q498.216.38102.7Supplier-supplied1MARGINAL
AX-2025-021281BCH-2505-Y7460Janoshik2025-Q498.306.66—Supplier-supplied1MARGINAL

Cross-sections

Other recent Semaglutide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041334WWBWWB-2606-N3192Janoshik2026-Q398.835.04—Supplier-supplied1MARGINAL
AX-2026-041932TFCTFC-2604-X4301Janoshik2026-Q398.884.31—Supplier-supplied0PASS
AX-2026-042347HJHJ-2608-C3931VendorInvestigate2026-Q398.803.41100.2Buyer-sourced1MARGINAL
AX-2026-041886JEEPJEEP-2607-X3911Nordanalyt2026-Q399.194.0396.4Supplier-supplied2MARGINAL
AX-2026-041337WWBWWB-2606-N3192Nordanalyt2026-Q398.964.81—Supplier-supplied1MARGINAL
AX-2026-042172HomopeptideHOMO-2604-X8921Janoshik2026-Q399.645.1691.9Supplier-supplied1MARGINAL
AX-2026-041767FGPFGP-2602-M1508PeptideMeter2026-Q398.652.54—Supplier-supplied2FAIL
AX-2026-041882JEEPJEEP-2607-X3911Nordanalyt2026-Q399.174.52—Supplier-supplied1MARGINAL
Other recent BCH records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043574N-Acetyl Semax AmideBCH-2602-E8253Janoshik2026-Q397.758.8597.9Supplier-supplied1FAIL
AX-2026-043503BPC-157BCH-2603-G6422Janoshik2026-Q398.464.32—Supplier-supplied1MARGINAL
AX-2026-043575N-Acetyl Semax AmideBCH-2602-E8253Janoshik2026-Q397.449.19104.8Supplier-supplied1FAIL
AX-2026-043539CJC-1295 with DACBCH-2607-H7307Janoshik2026-Q398.125.78100.6Supplier-supplied1MARGINAL
AX-2026-043504BPC-157BCH-2603-G6422Janoshik2026-Q398.384.4595.5Supplier-supplied1MARGINAL
AX-2026-043502BPC-157BCH-2603-G6422PeptideMeter2026-Q397.724.86—Buyer-sourced1FAIL
AX-2026-043501BPC-157BCH-2603-G6422PeptideMeter2026-Q398.374.75100.8Supplier-supplied1MARGINAL
AX-2026-043573N-Acetyl Semax AmideBCH-2602-E8253Janoshik2026-Q397.478.59—Supplier-supplied1FAIL