AX-2025-020992 · CJC-1295 with DAC · WXT lot WXT-2409-Y3760

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	97.20	% area	≥ 97.5	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.80	% area	≤ 2.5	FAIL
Largest single impurity	RP-HPLC — maleimide dimer	1.44	% area	≤ 1.00	FAIL
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	89.76	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	87.25	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.07	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.806	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	90.3	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.84	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.03	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.37	%	—	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	5.96	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	14.41	min	14.62 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.02	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	64,028	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.11	—	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 64,028, and skew follows the reported asymmetry factor of 1.02. 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 1.44 % impurity against a 97.20 % 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	14.41	4,724,221	97.20	—
2	maleimide dimer	16.83	69,988	1.44	+3644.975
3	hydrolysed maleimide (+18 Da)	13.79	35,966	0.74	+18.011
4	deamidated (+1 Da)	14.15	17,983	0.37	+0.984
5	mod-GRF (1-29) (−279 Da)	12.65	12,151	0.25	-279.235
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	5.84
Counter-ion (acetate)	ion chromatography	4.03
Residual solvent + inorganic residue	estimated	0.37
Total peptide content	by difference	89.76
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)	98.94	97.20	divergence +1.74 pp vs batch median
Total impurities (% area)	1.06	2.80
Largest single impurity (% area)	0.70	1.44
Water (%)	4.4	5.84
Counter-ion (%)	not stated	4.03
Peptide content (%w/w)	not stated	89.76
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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → submitter (2–8 °C, 12 d) → laboratory (courier, ambient, 5 d) → assay.
Assay date: 08 Mar 2025
Submitted to the index: 16 Mar 2025
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 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.

lambda_28016 Mar 2025

97.20 % on CJC-1295 with DAC is below the index specification for the class. The interesting part is the distribution: maleimide dimer at 1.44 % is doing most of the work, and that species is a synthesis artefact rather than a degradation product. This is a process observation about lot WXT-2409-Y3760, not a storage one.

dimer_disulfide16 Mar 2025

An intermolecular disulfide dimer elutes late and reduces cleanly. If the named table shows one, a non-reducing versus reducing comparison converts an unexplained impurity into an explained one.

low_n16 Mar 2025

Strong provenance does not fix small n. One well-sourced record is still one record, and the batch page says how many others exist for WXT-2409-Y3760.

Section 7

Related records

Same batch — lot WXT-2409-Y3760 n=7

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020988	WXT-2409-Y3760	Janoshik	2025-Q1	96.83	4.78	—	Buyer-sourced	1	FAIL
AX-2025-020989	WXT-2409-Y3760	Kestrel	2025-Q1	97.16	5.31	—	Buyer-sourced	1	FAIL
AX-2025-020990	WXT-2409-Y3760	Janoshik	2025-Q1	97.51	5.66	—	Supplier-supplied	1	MARGINAL
AX-2025-020991	WXT-2409-Y3760	Janoshik	2025-Q1	97.21	5.47	102.2	Buyer-sourced	1	FAIL
AX-2025-020993	WXT-2409-Y3760	Janoshik	2025-Q1	96.99	5.81	98.1	Buyer-sourced	1	FAIL
AX-2025-020994	WXT-2409-Y3760	Kestrel	2025-Q1	97.82	6.04	—	Buyer-sourced	1	MARGINAL

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 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