AX-2026-043407

CJC-1295 (no DAC) · 2 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2511-N3100

MARGINALPURITY ONLY

Report ID: AX-2026-043407
Compound: CJC-1295 (no DAC)
Compound class: Growth-hormone axis peptides
Supplier: WXT — WuXi TIDES (WuXi AppTec Testing Division)
Batch / lot: WXT-2511-N3100
Declared label claim: 2mg
Laboratory: Janoshik Analytical
Assay date: 17 Feb 2026
Submitted: 15 Mar 2026
Quarter: 2026-Q1
Submitter: vial_headspace
Sample provenance: Supplier-supplied

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	98.73	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.27	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — native GRF (1-29) (−59 Da)	0.54	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	3.37	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.65	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.15	%	—	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	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	6.04	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	12.99	min	12.86 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.10	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	66,046	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.16	—	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 66,046, and skew follows the reported asymmetry factor of 1.10. 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 0.54 % impurity against a 98.73 % 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 (no DAC) — main peak	12.99	4,798,584	98.73	—
2	native GRF (1-29) (−59 Da)	12.65	26,246	0.54	-58.995
3	acetyl adduct (+42 Da)	13.43	22,843	0.47	+42.011
4	des-Tyr1 (−163 Da)	12.45	5,346	0.11	-163.063
5	deamidated (+1 Da)	12.75	3,888	0.08	+0.984
6	truncated (1-24)	11.83	3,402	0.07	-570.291
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.

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)	98.5	98.73	divergence +0.49 pp vs batch median
Total impurities (% area)	1.50	1.27
Largest single impurity (% area)	not stated	0.54
Water (%)	2.7	3.37
Counter-ion (%)	5.9	4.65
Peptide content (%w/w)	90.8	not determined
Endotoxin (EU/mg)	0.27	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, 5 d) → assay. Submitter did not handle the vial.
Assay date: 17 Feb 2026
Submitted to the index: 15 Mar 2026
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.
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 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 3

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.

coa_gap15 Mar 2026

Rounding convention is the least of what a certificate carries. Lot code, method, wavelength and release date are the fields that let a reader reconstruct the figure, and the index scores those separately on the documentation rubric.

uncertainty_budget15 Mar 2026

Integration boundary on a close pair contributes up to 0.45 pp of standard uncertainty on its own. That is the term to quote alongside 98.73 % rather than a resolution verdict.

peak_integrator15 Mar 2026

Anyone comparing this purity figure against a result from a longer method should expect a difference of a few tenths in a predictable direction. The inter-lab page quantifies it per laboratory.

Section 7

Related records

Same batch — lot WXT-2511-N3100 n=4

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043408	WXT-2511-N3100	Janoshik	2026-Q1	97.89	4.34	—	Buyer-sourced	1	FAIL
AX-2026-043409	WXT-2511-N3100	Nordanalyt	2026-Q1	98.13	3.58	104.0	Buyer-sourced	1	MARGINAL
AX-2026-043410	WXT-2511-N3100	Janoshik	2026-Q1	97.52	3.03	105.4	Buyer-sourced	1	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent CJC-1295 (no DAC) records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042942	MKM	MKM-2603-V3346	Janoshik	2026-Q3	99.52	3.43	—	Supplier-supplied	0	PASS
AX-2026-041599	QSC	QSC-2606-V7416	VendorInvestigate	2026-Q3	97.96	3.52	—	Buyer-sourced	1	FAIL
AX-2026-042784	GGPeps	GGPE-2606-E1234	Medutest	2026-Q3	98.27	4.55	—	Buyer-sourced	0	PASS
AX-2026-042939	MKM	MKM-2603-V3346	PeptideMeter	2026-Q3	99.44	3.39	—	Buyer-sourced	0	PASS
AX-2026-041601	QSC	QSC-2606-V7416	Kestrel	2026-Q3	98.33	4.10	—	Buyer-sourced	1	MARGINAL
AX-2026-042945	MKM	MKM-2603-V3346	PeptideMeter	2026-Q3	99.39	3.54	—	Laboratory-retained	0	PASS
AX-2026-042786	GGPeps	GGPE-2606-E1234	Janoshik	2026-Q3	98.22	3.77	—	Buyer-sourced	0	PASS
AX-2026-041602	QSC	QSC-2606-V7416	VendorInvestigate	2026-Q3	98.36	3.38	101.8	Buyer-sourced	1	MARGINAL

Other recent WXT records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043376	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.08	4.22	—	Buyer-sourced	1	MARGINAL
AX-2026-043429	L-Glutathione (reduced)	WXT-2605-B3833	Nordanalyt	2026-Q3	98.48	6.58	96.9	Supplier-supplied	1	FAIL
AX-2026-043347	Leuprolide	WXT-2604-K2596	PeptideMeter	2026-Q3	99.16	5.99	93.6	Buyer-sourced	0	PASS
AX-2026-043353	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	99.19	4.90	95.3	Laboratory-retained	0	PASS
AX-2026-043345	Leuprolide	WXT-2604-K2596	Janoshik	2026-Q3	98.93	5.28	—	Buyer-sourced	0	PASS
AX-2026-043424	L-Glutathione (reduced)	WXT-2605-B3833	PeptideMeter	2026-Q3	98.37	6.86	—	Buyer-sourced	0	FAIL
AX-2026-043374	Semaglutide	WXT-2604-C3248	Janoshik	2026-Q3	97.00	3.56	—	Buyer-sourced	1	MARGINAL
AX-2026-043377	Semaglutide	WXT-2604-C3248	PeptideMeter	2026-Q3	97.20	4.08	—	Buyer-sourced	1	MARGINAL