AX-2025-018904

CJC-1295 with DAC · 10 mg declared · Thermo Fisher Scientific (China) Co., Ltd. · lot TFS-{CAT}-1220

MARGINALPURITY ONLY

Report ID: AX-2025-018904
Compound: CJC-1295 with DAC
Compound class: Growth-hormone axis peptides
Supplier: TFS — Thermo Fisher Scientific (China) Co., Ltd.
Batch / lot: TFS-{CAT}-1220
Declared label claim: 10mg
Laboratory: Janoshik Analytical
Assay date: 21 Jun 2025
Submitted: 11 Jul 2025
Quarter: 2025-Q2
Submitter: Contributor #L-4409
Sample provenance: Buyer-sourced

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	99.41	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.59	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — maleimide dimer	0.42	% 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	4.43	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.94	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.30	%	—	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	4.71	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	14.61	min	14.62 ± 0.35 (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	83,233	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.25	—	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 83,233, 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 0.42 % impurity against a 99.41 % 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	14.61	4,831,634	99.41	—
2	maleimide dimer	17.03	20,413	0.42	+3644.975
3	hydrolysed maleimide (+18 Da)	13.99	3,402	0.07	+18.011
4	mod-GRF (1-29) (−279 Da)	12.85	2,916	0.06	-279.235
5	deamidated (+1 Da)	14.35	1,944	0.04	+0.984
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)	98.68	99.41	divergence +0.04 pp vs batch median
Total impurities (% area)	1.32	0.59
Largest single impurity (% area)	not stated	0.42
Water (%)	2.1	4.43
Counter-ion (%)	5.8	3.94
Peptide content (%w/w)	91.5	not determined
Endotoxin (EU/mg)	0.11	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 (ambient, 19 d) → laboratory (courier, cold pack, 8 d) → assay.
Assay date: 21 Jun 2025
Submitted to the index: 11 Jul 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.
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.

des_gly11 Jul 2025

At 99.41 % the deletion-sequence family is at or below the reporting threshold. On a sequence with a hindered coupling that is a statement about coupling efficiency, and a good one.

plate_count11 Jul 2025

Plate count on this run supports the separation claimed. A high purity figure from an inefficient column is a merged peak reported as a clean one; that is not what happened here.

cleavage_cocktail11 Jul 2025

Alkylation artefacts from a scavenger-poor cleavage would appear as a +58 or +76 family here. Absent, which says the cleavage was run properly.

Section 7

Related records

Same batch — lot TFS-{CAT}-1220 n=14

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-018903	TFS-{CAT}-1220	Janoshik	2025-Q2	98.65	3.98	—	Buyer-sourced	1	MARGINAL
AX-2025-018905	TFS-{CAT}-1220	Janoshik	2025-Q2	98.72	4.16	105.3	Buyer-sourced	1	MARGINAL
AX-2025-018906	TFS-{CAT}-1220	PeptideMeter	2025-Q2	98.49	4.63	105.9	Buyer-sourced	1	MARGINAL
AX-2025-018907	TFS-{CAT}-1220	Janoshik	2025-Q2	99.27	4.97	103.6	Buyer-sourced	1	MARGINAL
AX-2025-018908	TFS-{CAT}-1220	PeptideMeter	2025-Q2	98.68	4.38	—	Buyer-sourced	1	MARGINAL
AX-2025-018909	TFS-{CAT}-1220	Medutest	2025-Q2	98.36	3.93	—	Buyer-sourced	1	MARGINAL
AX-2025-018910	TFS-{CAT}-1220	Janoshik	2025-Q2	98.60	4.26	96.7	Buyer-sourced	1	MARGINAL
AX-2025-018911	TFS-{CAT}-1220	Janoshik	2025-Q2	98.62	4.30	—	Buyer-sourced	1	MARGINAL
AX-2025-018912	TFS-{CAT}-1220	Janoshik	2025-Q2	98.75	4.74	—	Buyer-sourced	1	MARGINAL
AX-2025-018913	TFS-{CAT}-1220	Janoshik	2025-Q2	98.24	4.07	99.7	Laboratory-retained	1	MARGINAL
AX-2025-018914	TFS-{CAT}-1220	Janoshik	2025-Q2	98.87	4.81	103.0	Buyer-sourced	1	MARGINAL
AX-2025-018915	TFS-{CAT}-1220	Nordanalyt	2025-Q2	98.50	4.51	96.2	Buyer-sourced	1	MARGINAL
AX-2025-018916	TFS-{CAT}-1220	PeptideMeter	2025-Q2	98.36	3.96	99.0	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 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