AX-2026-041749

Cagrilintide · 5 mg declared · Thermo Fisher Scientific (China) Co., Ltd. · lot TFS-{CAT}-1681

MARGINALPURITY ONLY

Report ID: AX-2026-041749
Compound: Cagrilintide
Compound class: Incretin analogues and co-agonists
Supplier: TFS — Thermo Fisher Scientific (China) Co., Ltd.
Batch / lot: TFS-{CAT}-1681
Declared label claim: 5mg
Laboratory: Nordanalyt Laboratories
Assay date: 11 May 2026
Submitted: 13 May 2026
Quarter: 2026-Q2
Submitter: s.wikstrom
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.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 35 min gradient, 214 nm	99.54	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.46	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — open-chain (reduced disulfide, +2 Da)	0.17	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	83.40	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	83.02	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.36	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.450	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	89.0	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	4.21	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	11.46	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.93	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
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	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.10	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	19.14	min	19.31 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.90	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	78,911	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.84	—	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 78,911, and skew follows the reported asymmetry factor of 0.90. 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 0.17 % impurity against a 99.54 % 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	19.14	4,837,953	99.54	—
2	open-chain (reduced disulfide, +2 Da)	17.73	8,263	0.17	+2.016
3	disulfide-scrambled isomer	19.70	7,290	0.15	0.000
4	deamidated (+1 Da)	18.63	3,402	0.07	+0.984
5	des-C16 diacid (−254 Da)	14.92	3,402	0.07	-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 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	4.21
Counter-ion (TFA)	ion chromatography	11.46
Residual solvent + inorganic residue	estimated	0.93
Total peptide content	by difference	83.40
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)	99.90	99.54	divergence +0.56 pp vs batch median
Total impurities (% area)	not stated	0.46
Largest single impurity (% area)	not stated	0.17
Water (%)	4.5	4.21
Counter-ion (%)	not stated	11.46
Peptide content (%w/w)	not stated	83.40
Endotoxin (EU/mg)	1.68	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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Domestic warehouse despatch → submitter (2–8 °C, 9 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date: 11 May 2026
Submitted to the index: 13 May 2026
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-resolution MS
Verification status: PURITY ONLY

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name it.
That the material is free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
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 4

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.

buyer_sourced13 May 2026

Buyer-sourced through an ordinary retail order, so the supplier had no opportunity to select the vial. This is the provenance class the index weights and it is roughly 87 % of the dataset.

coa_reader13 May 2026

The certificate that arrives with a retail order is the certificate an ordinary buyer gets. Assessing it is assessing the real documentation practice rather than the sample-request one.

bland_altman13 May 2026

Where two laboratories tested the same retail lot, the paired difference is a clean estimate of inter-lab bias with no selection term in it at all. Those pairs are the backbone of the agreement analysis.

tfa_counter13 May 2026

The index's mass balance on this record closes to two decimal places with 11.46 % TFA in it. The number is not an anomaly; it is a component of a coherent gravimetric picture.

Section 7

Related records

Same batch — lot TFS-{CAT}-1681 n=13

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041738	TFS-{CAT}-1681	Janoshik	2026-Q2	99.48	5.18	103.5	Buyer-sourced	0	PASS
AX-2026-041739	TFS-{CAT}-1681	Janoshik	2026-Q2	99.09	4.66	98.4	Buyer-sourced	0	PASS
AX-2026-041740	TFS-{CAT}-1681	Kestrel	2026-Q2	99.93	5.15	104.9	Buyer-sourced	0	PASS
AX-2026-041741	TFS-{CAT}-1681	Janoshik	2026-Q2	99.24	5.16	—	Buyer-sourced	0	PASS
AX-2026-041742	TFS-{CAT}-1681	Janoshik	2026-Q2	99.54	4.54	—	Buyer-sourced	0	PASS
AX-2026-041743	TFS-{CAT}-1681	Medutest	2026-Q2	99.28	4.75	105.8	Buyer-sourced	0	PASS
AX-2026-041744	TFS-{CAT}-1681	Janoshik	2026-Q2	99.72	5.23	—	Buyer-sourced	0	PASS
AX-2026-041745	TFS-{CAT}-1681	VendorInvestigate	2026-Q2	98.59	4.51	—	Buyer-sourced	1	FAIL
AX-2026-041746	TFS-{CAT}-1681	PeptideMeter	2026-Q2	99.20	5.14	98.9	Buyer-sourced	0	PASS
AX-2026-041747	TFS-{CAT}-1681	Janoshik	2026-Q2	98.96	4.32	105.2	Buyer-sourced	0	PASS
AX-2026-041748	TFS-{CAT}-1681	Janoshik	2026-Q2	99.41	4.49	107.2	Buyer-sourced	0	PASS
AX-2026-041750	TFS-{CAT}-1681	Janoshik	2026-Q2	99.34	4.85	91.7	Buyer-sourced	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-2026-043557	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 TFS records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041681	CJC-1295 with DAC	TFS-{CAT}-9675	PeptideMeter	2026-Q3	98.82	3.67	—	Buyer-sourced	0	PASS
AX-2026-041766	BPC-157	TFS-{CAT}-1156	Janoshik	2026-Q3	99.54	6.34	—	Buyer-sourced	1	MARGINAL
AX-2026-041682	CJC-1295 with DAC	TFS-{CAT}-9675	Nordanalyt	2026-Q3	98.94	3.24	—	Buyer-sourced	0	PASS
AX-2026-041683	CJC-1295 with DAC	TFS-{CAT}-9675	Medutest	2026-Q3	98.68	3.46	97.0	Buyer-sourced	0	PASS
AX-2026-041765	BPC-157	TFS-{CAT}-1156	Janoshik	2026-Q3	99.79	6.01	—	Buyer-sourced	0	PASS
AX-2026-041680	CJC-1295 with DAC	TFS-{CAT}-9675	Medutest	2026-Q3	99.18	2.85	100.4	Buyer-sourced	0	PASS
AX-2026-041691	Semaglutide	TFS-{CAT}-9744	Janoshik	2026-Q2	98.31	6.07	91.4	Buyer-sourced	0	PASS
AX-2026-041700	SS-31 (Elamipretide)	TFS-{CAT}-1142	Medutest	2026-Q2	99.75	2.27	96.3	Buyer-sourced	0	PASS