AX-2025-020163 · CJC-1295 with DAC · ERP lot ERP-2506-E9178

Section 1

Results

Measured against the index acceptance specification for the growth-hormone axis peptides 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	98.98	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.02	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — hydrolysed maleimide (+18 Da)	0.37	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	3644.9748	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	3644.9671	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-2.1	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	89.77	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.85	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.11	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.875	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	93.8	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.82	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.42	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.99	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.82	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	White powder, no defined cake (melt-back)	—	white to off-white intact cake	FAIL
Reconstitution clarity	reconstituted per submitter procedure	Clear after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	6.31	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	14.70	min	14.62 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.11	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	67,246	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.12	—	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 67,246, 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 0.37 % impurity against a 98.98 % 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	CJC-1295 with DAC — main peak	14.70	4,810,735	98.98	—
2	hydrolysed maleimide (+18 Da)	14.08	17,983	0.37	+18.011
3	mod-GRF (1-29) (−279 Da)	12.94	16,525	0.34	-279.235
4	deamidated (+1 Da)	14.44	10,207	0.21	+0.984
5	maleimide dimer	17.12	4,860	0.10	+3644.975
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 3644.9748 Da, computed from C165H269N47O46. 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 3644.9671 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 (%)
5+	730.0022	730.0007	-0.0015	8.6
4+	912.2510	912.2491	-0.0019	52.5
3+	1215.9989	1215.9963	-0.0026	100.0
2+	1823.4947	1823.4908	-0.0039	51.6

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	4.82
Counter-ion (acetate)	ion chromatography	4.42
Residual solvent + inorganic residue	estimated	0.99
Total peptide content	by difference	89.77
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)	98.80	98.98	divergence -0.30 pp vs batch median
Total impurities (% area)	not stated	1.02
Largest single impurity (% area)	not stated	0.37
Water (%)	2.2	4.82
Counter-ion (%)	not stated	4.42
Peptide content (%w/w)	93.0	89.77
Endotoxin (EU/mg)	not stated	0.82
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: Retail purchase → submitter (ambient, 9 d) → laboratory (courier, cold pack, 12 d) → assay.
Assay date: 05 Sep 2025
Submitted to the index: 21 Sep 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 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 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.

quad_unit21 Sep 2025

Identity confirmed, purity 98.98 %, mass balance closed. This record is complete against the index definition of complete and there is nothing outstanding on it.

Section 7

Related records

Same batch — lot ERP-2506-E9178 n=8

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020161	ERP-2506-E9178	Janoshik	2025-Q3	99.41	4.33	93.5	Buyer-sourced	0	PASS
AX-2025-020162	ERP-2506-E9178	Janoshik	2025-Q3	99.22	4.55	102.4	Buyer-sourced	0	PASS
AX-2025-020164	ERP-2506-E9178	Kestrel	2025-Q3	99.23	4.62	—	Buyer-sourced	0	PASS
AX-2025-020165	ERP-2506-E9178	PeptideMeter	2025-Q3	99.05	4.21	—	Laboratory-retained	0	PASS
AX-2025-020166	ERP-2506-E9178	Kestrel	2025-Q3	98.97	4.55	—	Buyer-sourced	1	FAIL
AX-2025-020167	ERP-2506-E9178	Nordanalyt	2025-Q3	99.11	5.10	106.0	Buyer-sourced	0	PASS
AX-2025-020168	ERP-2506-E9178	Janoshik	2025-Q3	99.09	4.84	98.8	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent CJC-1295 with DAC records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041681	TFS	TFS-{CAT}-9675	PeptideMeter	2026-Q3	98.82	3.67	—	Buyer-sourced	0	PASS
AX-2026-041867	SinoPep	SNP-2607-C3886	Janoshik	2026-Q3	99.24	5.12	—	Laboratory-retained	1	FAIL
AX-2026-041682	TFS	TFS-{CAT}-9675	Nordanalyt	2026-Q3	98.94	3.24	—	Buyer-sourced	0	PASS
AX-2026-041683	TFS	TFS-{CAT}-9675	Medutest	2026-Q3	98.68	3.46	97.0	Buyer-sourced	0	PASS
AX-2026-043471	BCH	BCH-2607-H5235	Janoshik	2026-Q3	97.46	5.48	—	Buyer-sourced	1	FAIL
AX-2026-043477	BCH	BCH-2607-H5235	VendorInvestigate	2026-Q3	97.62	5.32	99.6	Buyer-sourced	1	MARGINAL
AX-2026-043470	BCH	BCH-2607-H5235	Janoshik	2026-Q3	97.76	6.11	99.3	Supplier-supplied	1	MARGINAL
AX-2026-043478	BCH	BCH-2607-H5235	PeptideMeter	2026-Q3	97.63	5.42	90.1	Buyer-sourced	1	MARGINAL

Other recent ERP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042706	Survodutide	ERP-2605-E9865	PeptideMeter	2026-Q3	98.38	5.33	103.5	Buyer-sourced	0	PASS
AX-2026-042704	Tesamorelin	ERP-2604-W9463	Janoshik	2026-Q3	99.02	4.08	—	Buyer-sourced	1	MARGINAL
AX-2026-042705	Survodutide	ERP-2605-E9865	Janoshik	2026-Q3	98.24	5.36	92.3	Buyer-sourced	0	PASS
AX-2026-042708	GHK-Cu	ERP-2601-F9816	Nordanalyt	2026-Q2	98.88	3.87	91.5	Buyer-sourced	1	MARGINAL
AX-2026-042694	Liraglutide	ERP-2601-P8985	Kestrel	2026-Q2	99.25	4.35	107.3	Buyer-sourced	1	MARGINAL
AX-2026-042707	GHK-Cu	ERP-2601-F9816	Janoshik	2026-Q2	98.53	4.70	96.3	Buyer-sourced	1	MARGINAL
AX-2026-042711	GHK-Cu	ERP-2601-F9816	Kestrel	2026-Q2	98.53	3.84	89.7	Laboratory-retained	2	MARGINAL
AX-2026-042722	Tirzepatide	ERP-2512-T9616	Medutest	2026-Q2	99.18	2.07	—	Buyer-sourced	1	MARGINAL