AX-2025-020700 · CJC-1295 (no DAC) · SGN lot SGN-2412-L9210

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, 35 min gradient, 214 nm	99.36	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.64	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — truncated (1-24)	0.30	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	3365.7402	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	3365.7298	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-3.1	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	91.00	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	90.42	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.05	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.566	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	91.3	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.37	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.13	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.50	%	—	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 cake, partial shrinkage from vial wall	—	white to off-white intact cake	FAIL
Reconstitution clarity	reconstituted per submitter procedure	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.20	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	15.09	min	14.83 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.99	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	72,108	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.22	—	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, 35 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 72,108, and skew follows the reported asymmetry factor of 0.99. 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 0.30 % impurity against a 99.36 % 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	15.09	4,829,204	99.36	—
2	truncated (1-24)	13.74	14,581	0.30	-570.291
3	acetyl adduct (+42 Da)	15.60	6,804	0.14	+42.011
4	des-Tyr1 (−163 Da)	14.46	3,888	0.08	-163.063
5	deamidated (+1 Da)	14.81	3,402	0.07	+0.984
6	native GRF (1-29) (−59 Da)	14.69	2,430	0.05	-58.995
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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 3365.7298 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	674.1532	-0.0021	8.7
4+	842.4423	842.4397	-0.0026	54.8
3+	1122.9207	1122.9172	-0.0035	100.0
2+	1683.8774	1683.8722	-0.0052	57.7

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.

Component	Determination	%w/w of cake
Water	Karl Fischer	4.37
Counter-ion (acetate)	ion chromatography	4.13
Residual solvent + inorganic residue	estimated	0.50
Total peptide content	by difference	91.00
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)	98.95	99.36	divergence -0.41 pp vs batch median
Total impurities (% area)	1.05	0.64
Largest single impurity (% area)	0.50	0.30
Water (%)	4.2	4.37
Counter-ion (%)	not stated	4.13
Peptide content (%w/w)	not stated	91.00
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 (−20 °C, 22 d) → laboratory (courier, dry ice, 3 d) → assay.
Assay date: 29 May 2025
Submitted to the index: 21 Jun 2025
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

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 2

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.

valley_drop21 Jun 2025

The index's position is that the integration convention must be stated, not that any particular convention must be used. Both are defensible; only one can be reported and it should be named.

gc_headspace21 Jun 2025

Residual solvent to the ICH limits is a stated requirement in regulated manufacture and an optional extra here. It is the slot most likely to hide something.

Section 7

Related records

Same batch — lot SGN-2412-L9210 n=5

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-020699	SGN-2412-L9210	Medutest	2025-Q2	99.31	5.34	107.2	Buyer-sourced	PASS
AX-2025-020701	SGN-2412-L9210	Janoshik	2025-Q2	99.36	4.89	—	Buyer-sourced	PASS
AX-2025-020702	SGN-2412-L9210	Janoshik	2025-Q2	99.27	4.93	105.7	Buyer-sourced	PASS
AX-2025-020703	SGN-2412-L9210	Kestrel	2025-Q2	99.53	5.05	90.0	Buyer-sourced	PASS

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 SGN records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043233	Afamelanotide	SGN-2602-Y9306	Janoshik	2026-Q3	98.76	4.02	92.2	Buyer-sourced	1	MARGINAL
AX-2026-043234	Afamelanotide	SGN-2602-Y9306	Kestrel	2026-Q3	99.93	4.16	—	Buyer-sourced	0	PASS
AX-2026-043240	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.82	5.46	97.0	Buyer-sourced	0	PASS
AX-2026-043222	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.32	7.36	—	Buyer-sourced	0	PASS
AX-2026-043237	SLU-PP-332	SGN-2602-X9377	Janoshik	2026-Q2	98.47	6.22	100.0	Supplier-supplied	0	PASS
AX-2026-043227	ARA-290	SGN-2605-X9069	PeptideMeter	2026-Q2	98.38	7.21	95.6	Buyer-sourced	0	PASS
AX-2026-043239	SLU-PP-332	SGN-2602-X9377	VendorInvestigate	2026-Q2	98.28	5.37	—	Buyer-sourced	0	PASS
AX-2026-043229	ARA-290	SGN-2605-X9069	Janoshik	2026-Q2	98.21	7.43	—	Buyer-sourced	0	PASS