AX-2024-005286 · Cagrilintide · BCH lot BCH-2402-C5045

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, 35 min gradient, 214 nm	98.27	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.73	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — open-chain (reduced disulfide, +2 Da)	0.83	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	3961.3218	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	3961.3064	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-3.9	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	87.62	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	86.10	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	10.57	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.101	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	91.0	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.05	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	7.87	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.46	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.35	EU/mg	≤ 5.0	PASS
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
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 with a single visible fibre	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	3.75	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	19.40	min	19.31 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.06	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	76,325	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.78	—	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, 35 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 76,325, and skew follows the reported asymmetry factor of 1.06. 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 0.83 % impurity against a 98.27 % 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	19.40	4,776,227	98.27	—
2	open-chain (reduced disulfide, +2 Da)	17.99	40,341	0.83	+2.016
3	cagrilintide dimer (intermolecular disulfide)	23.41	23,329	0.48	+3959.306
4	disulfide-scrambled isomer	19.96	14,095	0.29	0.000
5	deamidated (+1 Da)	18.89	4,374	0.09	+0.984
6	des-C16 diacid (−254 Da)	15.18	1,944	0.04	-254.225
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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 3961.3064 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	661.2250	-0.0026	7.9
5+	793.2716	793.2686	-0.0030	53.5
4+	991.3377	991.3339	-0.0038	100.0
3+	1321.4479	1321.4427	-0.0052	50.1
2+	1981.6682	1981.6605	-0.0077	8.7

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.

Component	Determination	%w/w of cake
Water	Karl Fischer	4.05
Counter-ion (TFA)	ion chromatography	7.87
Residual solvent + inorganic residue	estimated	0.46
Total peptide content	by difference	87.62
Total		100.00 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.

Figure	Supplier COA	This report	Index note
Purity (% area)	97.72	98.27	divergence -0.30 pp vs batch median
Total impurities (% area)	2.28	1.73
Largest single impurity (% area)	1.21	0.83
Water (%)	not stated	4.05
Counter-ion (%)	not stated	7.87
Peptide content (%w/w)	91.7	87.62
Endotoxin (EU/mg)	not stated	0.35
Method stated on certificate	NO	—	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 (ambient, 34 d) → laboratory (hand-carried, 6 d) → assay.
Assay date: 28 May 2024
Submitted to the index: 14 Jun 2024
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

That the material is sterile. Sterility was not tested.
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 2

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.

charge_envelope14 Jun 2024

Charge-state distribution here is unremarkable, which is itself informative: a shifted envelope is one of the earlier signs of aggregation or of a conformational population.

ms_confirm14 Jun 2024

An orthogonal identity method on the same lot would make this the strongest class of record the index holds. Mass plus retention is already better than most.

Section 7

Related records

Same batch — lot BCH-2402-C5045 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-005283	BCH-2402-C5045	Janoshik	2024-Q2	98.33	3.95	—	Supplier-supplied	PASS
AX-2024-005284	BCH-2402-C5045	Janoshik	2024-Q2	98.38	4.58	—	Buyer-sourced	PASS
AX-2024-005285	BCH-2402-C5045	VendorInvestigate	2024-Q2	97.38	4.21	95.0	Buyer-sourced	PASS
AX-2024-005287	BCH-2402-C5045	Medutest	2024-Q2	97.37	3.98	—	Buyer-sourced	PASS
AX-2024-005288	BCH-2402-C5045	PeptideMeter	2024-Q2	97.76	3.83	93.3	Buyer-sourced	PASS
AX-2024-005289	BCH-2402-C5045	VendorInvestigate	2024-Q2	97.71	3.65	95.1	Buyer-sourced	PASS
AX-2024-005290	BCH-2402-C5045	PeptideMeter	2024-Q2	98.27	4.09	96.0	Supplier-supplied	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-2026-043557	SIG	SIG-2603-6212	Janoshik	2026-Q2	98.28	4.41	99.0	Buyer-sourced	0	PASS
AX-2026-043545	SIG	SIG-2603-6212	Janoshik	2026-Q2	98.25	4.39	—	Buyer-sourced	0	PASS
AX-2026-043550	SIG	SIG-2603-6212	VendorInvestigate	2026-Q2	97.80	4.55	—	Buyer-sourced	0	PASS
AX-2026-042636	SWB	SWB-2601-J7710	Nordanalyt	2026-Q2	98.96	4.47	92.7	Buyer-sourced	0	PASS
AX-2026-041740	TFS	TFS-{CAT}-1681	Kestrel	2026-Q2	99.93	5.15	104.9	Buyer-sourced	0	PASS
AX-2026-041743	TFS	TFS-{CAT}-1681	Medutest	2026-Q2	99.28	4.75	105.8	Buyer-sourced	0	PASS
AX-2026-042863	GGPeps	GGPE-2603-R2320	Medutest	2026-Q2	98.13	6.46	88.7	Supplier-supplied	1	MARGINAL
AX-2026-042148	JEEP	JEEP-2603-E9024	Janoshik	2026-Q2	98.66	6.33	—	Buyer-sourced	0	PASS

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043445	BPC-157	BCH-2603-G4350	Nordanalyt	2026-Q3	98.42	4.87	93.6	Buyer-sourced	1	MARGINAL
AX-2026-043440	BPC-157	BCH-2603-G4350	VendorInvestigate	2026-Q3	98.61	4.11	—	Buyer-sourced	1	MARGINAL
AX-2026-043442	BPC-157	BCH-2603-G4350	Janoshik	2026-Q3	98.65	4.78	—	Buyer-sourced	1	MARGINAL
AX-2026-043471	CJC-1295 with DAC	BCH-2607-H5235	Janoshik	2026-Q3	97.46	5.48	—	Buyer-sourced	1	FAIL
AX-2026-043477	CJC-1295 with DAC	BCH-2607-H5235	VendorInvestigate	2026-Q3	97.62	5.32	99.6	Buyer-sourced	1	MARGINAL
AX-2026-043449	BPC-157	BCH-2603-G4350	Kestrel	2026-Q3	99.74	4.92	91.3	Supplier-supplied	2	MARGINAL
AX-2026-043448	BPC-157	BCH-2603-G4350	Janoshik	2026-Q3	98.55	4.69	106.9	Buyer-sourced	1	MARGINAL
AX-2026-043470	CJC-1295 with DAC	BCH-2607-H5235	Janoshik	2026-Q3	97.76	6.11	99.3	Supplier-supplied	1	MARGINAL