AX-2025-020863 · CJC-1295 (no DAC) · CPC lot CPC-2509-L1903

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, 25 min gradient, 214 nm	97.64	% area	≥ 98.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	2.36	% area	≤ 2.0	FAIL
Largest single impurity	RP-HPLC — native GRF (1-29) (−59 Da)	1.16	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	3365.7402	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	3365.7267	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-4.0	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	5.89	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.46	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.53	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	10.54	EU/mg	≤ 5.0	FAIL
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
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	3.82	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	10.86	min	10.89 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.04	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	49,759	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.00	—	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, 25 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 49,759, and skew follows the reported asymmetry factor of 1.04. 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 1.16 % impurity against a 97.64 % 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	10.86	4,745,607	97.64	—
2	native GRF (1-29) (−59 Da)	10.58	56,380	1.16	-58.995
3	des-Tyr1 (−163 Da)	10.41	31,106	0.64	-163.063
4	deamidated (+1 Da)	10.66	14,581	0.30	+0.984
5	acetyl adduct (+42 Da)	11.23	7,290	0.15	+42.011
6	truncated (1-24)	9.89	5,346	0.11	-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 3

Mass spectrum and identity

Theoretical monoisotopic mass 3365.7402 Da, computed from C152H252N44O42. All ppm figures on this site are against monoisotopic values — see why that matters.

Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 3365.7267 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+	674.1553	674.1526	-0.0027	8.8
4+	842.4423	842.4390	-0.0033	54.8
3+	1122.9207	1122.9162	-0.0045	100.0
2+	1683.8774	1683.8706	-0.0068	56.7

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)	98.02	97.64	divergence +0.24 pp vs batch median
Total impurities (% area)	not stated	2.36
Largest single impurity (% area)	not stated	1.16
Water (%)	not stated	5.89
Counter-ion (%)	not stated	5.46
Peptide content (%w/w)	not stated	not determined
Endotoxin (EU/mg)	not stated	10.54
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, 12 d) → assay. Submitter did not handle the vial.
Assay date: 25 Oct 2025
Submitted to the index: 07 Nov 2025
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
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 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 5

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.

multiple_compare07 Nov 2025

Endotoxin determined but the LAL method is not stated. Kinetic chromogenic and gel-clot give different results and different sensitivity. The value cannot be interpreted without knowing which.

retest_date07 Nov 2025

Endotoxin tested twice on this lot with varying EU/mg spread. Endotoxin variability in retained samples is larger than most labs acknowledge and the single measurement here is not definitive.

Contributor #Y-813507 Nov 2025

High endotoxin 10.54 EU/mg on high-purity material vs purity suggests water quality at the fill step. If the lot was lyophilised from non-purified water, this is the expected finding.

disulfide_fold07 Nov 2025

Endotoxin undetectable means below the detection limit of on Medutest's system. That does not mean zero and may not reflect actual endotoxin. The cutoff is useful for screening; the absence of a number is not a guarantee.

sole_source07 Nov 2025

Endotoxin assay but no bacterial viability or total count. The two are independent: dead endotoxin-bearing bacteria contribute to the burden, living ones that produce endotoxins do not.

Section 7

Related records

Same batch — lot CPC-2509-L1903 n=14

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-020862	CPC-2509-L1903	VendorInvestigate	2025-Q4	97.40	6.28	101.0	Buyer-sourced	1	FAIL
AX-2025-020864	CPC-2509-L1903	PeptideMeter	2025-Q4	97.80	6.57	97.5	Supplier-supplied	2	FAIL
AX-2025-020865	CPC-2509-L1903	PeptideMeter	2025-Q4	97.75	6.32	106.3	Supplier-supplied	2	FAIL
AX-2025-020866	CPC-2509-L1903	Medutest	2025-Q4	98.51	5.87	103.2	Supplier-supplied	2	MARGINAL
AX-2025-020867	CPC-2509-L1903	VendorInvestigate	2025-Q4	97.82	6.03	—	Buyer-sourced	2	FAIL
AX-2025-020868	CPC-2509-L1903	Janoshik	2025-Q4	98.08	6.57	106.7	Supplier-supplied	1	MARGINAL
AX-2025-020869	CPC-2509-L1903	Janoshik	2025-Q4	98.41	5.42	—	Supplier-supplied	1	MARGINAL
AX-2025-020870	CPC-2509-L1903	Medutest	2025-Q4	97.66	6.44	—	Supplier-supplied	2	FAIL
AX-2025-020871	CPC-2509-L1903	Janoshik	2025-Q4	98.23	6.11	—	Supplier-supplied	2	MARGINAL
AX-2025-020872	CPC-2509-L1903	Janoshik	2025-Q4	97.41	5.61	98.4	Buyer-sourced	2	FAIL
AX-2025-020873	CPC-2509-L1903	Medutest	2025-Q4	96.96	5.77	92.7	Buyer-sourced	1	FAIL
AX-2025-020874	CPC-2509-L1903	PeptideMeter	2025-Q4	97.98	6.73	90.4	Supplier-supplied	2	FAIL
AX-2025-020875	CPC-2509-L1903	Medutest	2025-Q4	97.53	6.48	101.9	Supplier-supplied	2	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-2026-041683	QSC	QSC-2606-V8637	Janoshik	2026-Q3	99.93	3.63	97.1	Supplier-supplied	1	FAIL
AX-2026-042669	GGPeps	GGPE-2606-E8495	Medutest	2026-Q3	98.61	4.06	95.5	Supplier-supplied	0	PASS
AX-2026-042665	GGPeps	GGPE-2606-E8495	Janoshik	2026-Q3	98.44	4.00	93.2	Supplier-supplied	1	MARGINAL
AX-2026-042663	GGPeps	GGPE-2606-E8495	Medutest	2026-Q3	97.96	4.14	90.0	Laboratory-retained	2	FAIL
AX-2026-042662	GGPeps	GGPE-2606-E8495	Janoshik	2026-Q3	97.89	4.11	95.1	Supplier-supplied	0	FAIL
AX-2026-041686	QSC	QSC-2606-V8637	Janoshik	2026-Q3	99.93	4.04	—	Supplier-supplied	0	PASS
AX-2026-042666	GGPeps	GGPE-2606-E8495	Janoshik	2026-Q3	97.87	3.74	94.3	Buyer-sourced	2	FAIL
AX-2026-042668	GGPeps	GGPE-2606-E8495	Nordanalyt	2026-Q3	98.02	4.53	103.9	Supplier-supplied	1	MARGINAL

Other recent CPC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043368	N-Acetyl Semax Amide	CPC-2602-D2941	Medutest	2026-Q3	98.79	6.05	102.1	Supplier-supplied	0	PASS
AX-2026-043335	Liraglutide	CPC-2602-G1978	Janoshik	2026-Q3	97.29	4.91	—	Laboratory-retained	1	FAIL
AX-2026-043283	L-Carnosine	CPC-2603-G1651	Medutest	2026-Q3	98.10	10.12	91.8	Supplier-supplied	1	FAIL
AX-2026-043365	BPC-157	CPC-2602-W2646	Medutest	2026-Q3	98.56	2.80	—	Supplier-supplied	1	MARGINAL
AX-2026-043332	Liraglutide	CPC-2602-G1978	Janoshik	2026-Q3	97.16	4.88	91.3	Supplier-supplied	1	FAIL
AX-2026-043289	L-Carnosine	CPC-2603-G1651	Janoshik	2026-Q3	98.01	10.52	—	Buyer-sourced	1	FAIL
AX-2026-043287	L-Carnosine	CPC-2603-G1651	Janoshik	2026-Q3	98.35	9.89	93.2	Supplier-supplied	2	FAIL
AX-2026-043367	N-Acetyl Semax Amide	CPC-2602-D2941	Nordanalyt	2026-Q3	99.39	6.16	92.4	Supplier-supplied	0	PASS