AX-2026-042749

Cagrilintide · 2 mg declared · Nantong Guangyuan Chemical Co., Ltd. · lot GGPE-2603-R9581

FAILIDENTITY CONSISTENT

Report ID: AX-2026-042749
Compound: Cagrilintide
Compound class: Incretin analogues and co-agonists
Supplier: GGPeps — Nantong Guangyuan Chemical Co., Ltd.
Batch / lot: GGPE-2603-R9581
Declared label claim: 2mg
Laboratory: Medutest
Assay date: 10 May 2026
Submitted: 02 Jun 2026
Quarter: 2026-Q2
Submitter: y.bergstrom
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.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 25 min gradient, 214 nm	97.95	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	2.05	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — open-chain (reduced disulfide, +2 Da)	0.89	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	3961.3218	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	3961.2481	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-18.6	ppm	± 15	FAIL
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	6.05	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	9.62	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.44	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
Appearance	visual, diffuse light, black and white background	Off-white lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	3.70	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	14.05	min	14.17 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.15	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	76,819	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.76	—	no index criterion	REPORTED

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.

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 76,819, and skew follows the reported asymmetry factor of 1.15. 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 0.89 % impurity against a 97.95 % main peak is a line two pixels tall; the main peak runs off-scale there by design.

#	Peak	RT	Area (µV·s)	% area	Δ mass (Da)
1	Cagrilintide — main peak	14.05	4,760,674	97.95	—
2	open-chain (reduced disulfide, +2 Da)	13.04	43,257	0.89	+2.016
3	deamidated (+1 Da)	13.68	30,134	0.62	+0.984
4	disulfide-scrambled isomer	14.45	12,151	0.25	0.000
5	des-C16 diacid (−254 Da)	11.03	7,290	0.15	-254.225
6	cagrilintide dimer (intermolecular disulfide)	16.92	6,804	0.14	+3959.306
Closure check — purity + Σ impurities				100.00	CLOSES

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.

Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 3961.2481 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.

Charge	Theoretical m/z	Observed m/z	Δ m/z	Rel. abundance (%)
6+	661.2276	661.2153	-0.0123	8.1
5+	793.2716	793.2569	-0.0147	55.6
4+	991.3377	991.3193	-0.0184	100.0
3+	1321.4479	1321.4233	-0.0246	53.2
2+	1981.6682	1981.6313	-0.0369	8.1

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.

Figure	Supplier COA	This report	Index note
Purity (% area)	98.33	97.95	divergence +0.62 pp vs batch median
Total impurities (% area)	not stated	2.05
Largest single impurity (% area)	not stated	0.89
Water (%)	4.2	6.05
Counter-ion (%)	not stated	9.62
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	YES	—	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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 9 d) → assay. Submitter did not handle the vial.
Assay date: 10 May 2026
Submitted to the index: 02 Jun 2026
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
That the material is free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
That any other vial in the same lot has the same composition. One vial was tested. Within-lot vial-to-vial variation in this index has a median of 0.28 pp and a 90th percentile of 0.74 pp.
That any other lot from the same supplier has the same composition. Batch-to-batch variation is larger than within-batch variation for every supplier here.
That the material is suitable for administration to a human or an animal. These are research compounds. No result on this site is a safety assessment and the index takes no position on use.
That the material was manufactured by the supplier that sold it. Contract synthesis is normal in this market and twenty-nine batches in the index fingerprint to a bulk from a different company than the one named on the label.

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 GGPE-2603-R9581 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042750	GGPE-2603-R9581	Janoshik	2026-Q2	97.46	5.31	98.5	Supplier-supplied	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Cagrilintide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041747	FGP	FGP-2602-M9870	Nordanalyt	2026-Q2	98.03	3.83	—	Supplier-supplied	0	PASS
AX-2026-041749	FGP	FGP-2602-M9870	Janoshik	2026-Q2	99.47	4.14	—	Supplier-supplied	0	PASS
AX-2026-041877	JEEP	JEEP-2603-E3844	Janoshik	2026-Q2	99.61	6.44	—	Supplier-supplied	0	PASS
AX-2026-042386	SWB	SWB-2601-J5083	Janoshik	2026-Q2	99.15	4.21	101.5	Supplier-supplied	0	PASS
AX-2026-041876	JEEP	JEEP-2603-E3844	PeptideMeter	2026-Q2	99.47	6.11	—	Supplier-supplied	1	MARGINAL
AX-2026-041748	FGP	FGP-2602-M9870	PeptideMeter	2026-Q2	98.88	4.01	99.6	Supplier-supplied	0	PASS
AX-2026-041750	FGP	FGP-2602-M9870	Medutest	2026-Q2	98.58	3.43	93.1	Supplier-supplied	0	PASS
AX-2026-042750	GGPeps	GGPE-2603-R9581	Janoshik	2026-Q2	97.46	5.31	98.5	Supplier-supplied	0	PASS

Other recent GGPeps records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042737	Selank	GGPE-2603-J9708	Janoshik	2026-Q3	98.40	9.14	97.4	Buyer-sourced	0	FAIL
AX-2026-042804	Selank	GGPE-2602-G2056	Janoshik	2026-Q3	98.50	7.97	—	Supplier-supplied	0	FAIL
AX-2026-042803	Selank	GGPE-2602-G2056	Janoshik	2026-Q3	98.48	8.01	—	Laboratory-retained	1	FAIL
AX-2026-042802	Selank	GGPE-2602-G2056	Janoshik	2026-Q3	98.74	7.09	96.0	Supplier-supplied	0	FAIL
AX-2026-042796	Selank	GGPE-2602-G2056	Janoshik	2026-Q3	98.26	7.56	97.5	Buyer-sourced	0	FAIL
AX-2026-042648	Melanotan II	GGPE-2603-P8735	Janoshik	2026-Q3	99.10	6.97	—	Supplier-supplied	4	MARGINAL
AX-2026-042797	Selank	GGPE-2602-G2056	Medutest	2026-Q3	98.46	7.92	—	Buyer-sourced	0	FAIL
AX-2026-042669	CJC-1295 (no DAC)	GGPE-2606-E8495	Medutest	2026-Q3	98.61	4.06	95.5	Supplier-supplied	0	PASS