AX-2025-019288 · CJC-1295 with DAC · AMB lot AMB-2412-N5535

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	99.17	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.83	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — mod-GRF (1-29) (−279 Da)	0.34	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	3644.9748	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	3644.8669	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-29.6	ppm	± 15	FAIL
Total peptide content	by difference from the gravimetric mass balance	89.91	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	89.16	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.63	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	5.020	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	100.4	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.50	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.35	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.24	%	—	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 to pale-yellow 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	6.00	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	14.48	min	14.62 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.30	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	57,641	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.05	—	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 57,641, and skew follows the reported asymmetry factor of 1.30. 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 0.34 % impurity against a 99.17 % 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	14.48	4,819,969	99.17	—
2	mod-GRF (1-29) (−279 Da)	12.72	16,525	0.34	-279.235
3	hydrolysed maleimide (+18 Da)	13.86	10,207	0.21	+18.011
4	maleimide dimer	16.90	7,290	0.15	+3644.975
5	deamidated (+1 Da)	14.22	6,318	0.13	+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 3

Mass spectrum and identity

Theoretical monoisotopic mass 3644.9748 Da, computed from C165H269N47O46. 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 3644.8669 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+	730.0022	729.9807	-0.0215	9.2
4+	912.2510	912.2240	-0.0270	56.9
3+	1215.9989	1215.9629	-0.0360	100.0
2+	1823.4947	1823.4407	-0.0540	55.0

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	4.50
Counter-ion (acetate)	ion chromatography	5.35
Residual solvent + inorganic residue	estimated	0.24
Total peptide content	by difference	89.91
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)	98.99	99.17	divergence -0.18 pp vs batch median
Total impurities (% area)	1.01	0.83
Largest single impurity (% area)	0.69	0.34
Water (%)	3.8	4.50
Counter-ion (%)	5.3	5.35
Peptide content (%w/w)	90.3	89.91
Endotoxin (EU/mg)	1.16	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, 18 d) → laboratory (hand-carried, 9 d) → assay.
Assay date: 12 Jan 2025
Submitted to the index: 25 Jan 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 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 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.

isotope_cluster25 Jan 2025

At this mass the monoisotopic peak may not be the most intense peak in the cluster. Picking the apex instead of the monoisotopic peak produces a systematic positive error of roughly the size flagged here.

endotoxin_limit25 Jan 2025

Any buyer can order the test on their own vial for the price of a small order. It is the single most under-purchased measurement in this market.

bland_altman25 Jan 2025

Agreement analysis needs paired observations and this lot supplies none. The pairs that exist elsewhere are what the laboratory bias estimates rest on.

Section 7

Related records

Same batch — lot AMB-2412-N5535 n=1

This is the only report on this lot. One report is not a batch characterisation.

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 AMB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042002	Semaglutide	AMB-2607-N6274	VendorInvestigate	2026-Q3	98.23	6.37	97.1	Buyer-sourced	1	MARGINAL
AX-2026-042012	GHRP-6	AMB-2603-S5667	Janoshik	2026-Q3	99.37	5.90	88.8	Laboratory-retained	1	MARGINAL
AX-2026-041974	Tirzepatide	AMB-2603-C5112	Nordanalyt	2026-Q3	98.20	3.41	—	Buyer-sourced	0	PASS
AX-2026-041975	Tirzepatide	AMB-2603-C5112	Medutest	2026-Q3	97.88	3.45	106.9	Laboratory-retained	0	PASS
AX-2026-042005	Semaglutide	AMB-2607-N6274	PeptideMeter	2026-Q3	98.09	6.48	98.6	Buyer-sourced	1	MARGINAL
AX-2026-042008	Epitalon	AMB-2602-Y6433	Janoshik	2026-Q3	99.30	8.75	105.1	Buyer-sourced	0	PASS
AX-2026-042021	TB-500	AMB-2602-P5987	VendorInvestigate	2026-Q3	99.86	4.79	101.4	Buyer-sourced	0	PASS
AX-2026-042015	GHRP-6	AMB-2603-S5667	Janoshik	2026-Q3	99.54	6.44	97.1	Buyer-sourced	0	PASS