AX-2024-005490

Cagrilintide · 10 mg declared · Bachem Holding (Suzhou) Co., Ltd. · lot BCH-2402-C7117

PASSPURITY ONLY

Report ID: AX-2024-005490
Compound: Cagrilintide
Compound class: Incretin analogues and co-agonists
Supplier: BCH — Bachem Holding (Suzhou) Co., Ltd.
Batch / lot: BCH-2402-C7117
Declared label claim: 10mg
Laboratory: Janoshik Analytical
Assay date: 28 Apr 2024
Submitted: 16 May 2024
Quarter: 2024-Q2
Submitter: r.lindholm
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, 30 min gradient, 214 nm	98.89	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.11	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — open-chain (reduced disulfide, +2 Da)	0.53	% 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	85.30	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	84.35	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	12.48	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	10.527	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	105.3	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.22	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	9.57	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.91	%	—	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	Clear, colourless, no visible particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	3.07	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	16.70	min	16.74 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.28	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	78,259	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.80	—	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, 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 78,259, and skew follows the reported asymmetry factor of 1.28. 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 0.53 % impurity against a 98.89 % 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	16.70	4,806,361	98.89	—
2	open-chain (reduced disulfide, +2 Da)	15.49	25,760	0.53	+2.016
3	cagrilintide dimer (intermolecular disulfide)	20.14	15,067	0.31	+3959.306
4	disulfide-scrambled isomer	17.18	9,235	0.19	0.000
5	deamidated (+1 Da)	16.26	2,916	0.06	+0.984
6	des-C16 diacid (−254 Da)	13.08	972	0.02	-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	4.22
Counter-ion (TFA)	ion chromatography	9.57
Residual solvent + inorganic residue	estimated	0.91
Total peptide content	by difference	85.30
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)	98.13	98.89	divergence +0.06 pp vs batch median
Total impurities (% area)	1.87	1.11
Largest single impurity (% area)	1.09	0.53
Water (%)	1.6	4.22
Counter-ion (%)	not stated	9.57
Peptide content (%w/w)	93.6	85.30
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, 2 d) → assay. Submitter did not handle the vial.
Assay date: 28 Apr 2024
Submitted to the index: 16 May 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 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

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-2402-C7117 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-005487	BCH-2402-C7117	Janoshik	2024-Q2	97.80	3.64	106.4	Supplier-supplied	PASS
AX-2024-005488	BCH-2402-C7117	Kestrel	2024-Q2	99.91	4.19	102.6	Supplier-supplied	PASS
AX-2024-005489	BCH-2402-C7117	Janoshik	2024-Q2	97.59	2.64	91.1	Laboratory-retained	PASS
AX-2024-005491	BCH-2402-C7117	Medutest	2024-Q2	97.91	3.64	—	Supplier-supplied	PASS
AX-2024-005492	BCH-2402-C7117	Janoshik	2024-Q2	98.22	3.91	97.0	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-2026-041747	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-2026-042749	GGPeps	GGPE-2603-R9581	Medutest	2026-Q2	97.95	6.05	—	Supplier-supplied	1	FAIL
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

Other recent BCH records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043574	N-Acetyl Semax Amide	BCH-2602-E8253	Janoshik	2026-Q3	97.75	8.85	97.9	Supplier-supplied	1	FAIL
AX-2026-043503	BPC-157	BCH-2603-G6422	Janoshik	2026-Q3	98.46	4.32	—	Supplier-supplied	1	MARGINAL
AX-2026-043575	N-Acetyl Semax Amide	BCH-2602-E8253	Janoshik	2026-Q3	97.44	9.19	104.8	Supplier-supplied	1	FAIL
AX-2026-043539	CJC-1295 with DAC	BCH-2607-H7307	Janoshik	2026-Q3	98.12	5.78	100.6	Supplier-supplied	1	MARGINAL
AX-2026-043504	BPC-157	BCH-2603-G6422	Janoshik	2026-Q3	98.38	4.45	95.5	Supplier-supplied	1	MARGINAL
AX-2026-043502	BPC-157	BCH-2603-G6422	PeptideMeter	2026-Q3	97.72	4.86	—	Buyer-sourced	1	FAIL
AX-2026-043501	BPC-157	BCH-2603-G6422	PeptideMeter	2026-Q3	98.37	4.75	100.8	Supplier-supplied	1	MARGINAL
AX-2026-043573	N-Acetyl Semax Amide	BCH-2602-E8253	Janoshik	2026-Q3	97.47	8.59	—	Supplier-supplied	1	FAIL