AssayIndex

AX-2024-005288

Cagrilintide · 10 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2402-C5045

PASSVERIFIED
Report ID
AX-2024-005288
Compound
Cagrilintide
Compound class
Incretin analogues and co-agonists
Supplier
BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot
BCH-2402-C5045
Declared label claim
10mg
Laboratory
PeptideMeter
Assay date
12 Jun 2024
Submitted
21 Jun 2024
Quarter
2024-Q2
Submitter
recon_clarity
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 nm97.76% area≥ 96.5PASS
Total impuritiesRP-HPLC, sum of reported peaks2.24% area≤ 3.5PASS
Largest single impurityRP-HPLC — open-chain (reduced disulfide, +2 Da)1.07% area≤ 1.00FAIL
Identity — theoretical monoisotopic masscalculated from molecular formula3961.3218Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)3961.3313Da—NOT TESTED
Mass accuracyobserved vs theoretical+2.4ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance88.06%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity86.09%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen10.84mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content9.332mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim93.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate3.83%≤ 8.0PASS
Counter-ion (TFA)anion-exchange ion chromatography7.32%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.79%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.23EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 d—no growthPASS
Appearancevisual, diffuse light, black and white backgroundWhite cake, partially collapsed—white to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration3.68—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient15.78min15.71 ± 0.45 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.11—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²73,208—≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)1.72—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.

01839367855187357 Cagrilintide15.78 min · 97.76 % 14.6518.9912.40 same trace · ×50 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 73,208, and skew follows the reported asymmetry factor of 1.11. 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 1.07 % 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)
1Cagrilintide — main peak15.784,751,43997.76—
2open-chain (reduced disulfide, +2 Da)14.6552,0051.07+2.016
3cagrilintide dimer (intermolecular disulfide)18.9930,1340.62+3959.306
4disulfide-scrambled isomer16.2317,9830.370.000
5deamidated (+1 Da)15.375,8320.12+0.984
6des-C16 diacid (−254 Da)12.402,9160.06-254.225
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 3961.3218 Da, computed from C194H310N54O61. All ppm figures on this site are against monoisotopic values — see why that matters.

025507510050077510501325160018752150 [M+4H]4+991.34[M+3H]3+1321.45[M+5H]5+793.27 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 3961.3313 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+661.2276661.22920.00167.6
5+793.2716793.27350.001950.7
4+991.3377991.34010.0024100.0
3+1321.44791321.45100.003153.9
2+1981.66821981.67290.00478.3
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 Fischer3.83
Counter-ion (TFA)ion chromatography7.32
Residual solvent + inorganic residueestimated0.79
Total peptide contentby difference88.06
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)97.7297.76divergence -0.30 pp vs batch median
Total impurities (% area)2.282.24
Largest single impurity (% area)1.211.07
Water (%)not stated3.83
Counter-ion (%)not stated7.32
Peptide content (%w/w)91.788.06
Endotoxin (EU/mg)not stated0.23
Method stated on certificateNO—no 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, 16 d) → laboratory (courier, dry ice, 9 d) → assay.
Assay date
12 Jun 2024
Submitted to the index
21 Jun 2024
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 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 vial at 97.76 % is worth more evidentially than a selected vial at a higher figure. That is the whole argument for recording provenance at all.
Section 7

Related records

Same batch — lot BCH-2402-C5045 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-005283BCH-2402-C5045Janoshik2024-Q298.333.95—Supplier-supplied0PASS
AX-2024-005284BCH-2402-C5045Janoshik2024-Q298.384.58—Buyer-sourced0PASS
AX-2024-005285BCH-2402-C5045VendorInvestigate2024-Q297.384.2195.0Buyer-sourced0PASS
AX-2024-005286BCH-2402-C5045Nordanalyt2024-Q298.274.0591.0Buyer-sourced0PASS
AX-2024-005287BCH-2402-C5045Medutest2024-Q297.373.98—Buyer-sourced0PASS
AX-2024-005289BCH-2402-C5045VendorInvestigate2024-Q297.713.6595.1Buyer-sourced0PASS
AX-2024-005290BCH-2402-C5045PeptideMeter2024-Q298.274.0996.0Supplier-supplied0PASS

Cross-sections

Other recent Cagrilintide records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043557SIGSIG-2603-6212Janoshik2026-Q298.284.4199.0Buyer-sourced0PASS
AX-2026-043545SIGSIG-2603-6212Janoshik2026-Q298.254.39—Buyer-sourced0PASS
AX-2026-043550SIGSIG-2603-6212VendorInvestigate2026-Q297.804.55—Buyer-sourced0PASS
AX-2026-042636SWBSWB-2601-J7710Nordanalyt2026-Q298.964.4792.7Buyer-sourced0PASS
AX-2026-041740TFSTFS-{CAT}-1681Kestrel2026-Q299.935.15104.9Buyer-sourced0PASS
AX-2026-041743TFSTFS-{CAT}-1681Medutest2026-Q299.284.75105.8Buyer-sourced0PASS
AX-2026-042863GGPepsGGPE-2603-R2320Medutest2026-Q298.136.4688.7Supplier-supplied1MARGINAL
AX-2026-042148JEEPJEEP-2603-E9024Janoshik2026-Q298.666.33—Buyer-sourced0PASS
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-Q398.614.11—Buyer-sourced1MARGINAL
AX-2026-043442BPC-157BCH-2603-G4350Janoshik2026-Q398.654.78—Buyer-sourced1MARGINAL
AX-2026-043471CJC-1295 with DACBCH-2607-H5235Janoshik2026-Q397.465.48—Buyer-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