AX-2025-018835 · CJC-1295 (no DAC) · FGP lot FGP-2503-P8516

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	99.53	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.47	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — native GRF (1-29) (−59 Da)	0.29	% 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)	3365.7449	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+1.4	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	89.00	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.58	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	10.48	mg	10 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	9.283	mg	10 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	92.8	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	6.56	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.21	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.23	%	—	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	5.59	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	12.75	min	12.86 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.19	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	89,249	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated (+1 Da)	1.37	—	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 89,249, and skew follows the reported asymmetry factor of 1.19. 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 0.29 % impurity against a 99.53 % 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	12.75	4,837,467	99.53	—
2	native GRF (1-29) (−59 Da)	12.41	14,095	0.29	-58.995
3	des-Tyr1 (−163 Da)	12.21	4,860	0.10	-163.063
4	acetyl adduct (+42 Da)	13.19	1,944	0.04	+42.011
5	deamidated (+1 Da)	12.51	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 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 3365.7449 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	674.1563	0.0010	8.0
4+	842.4423	842.4435	0.0012	54.5
3+	1122.9207	1122.9222	0.0015	100.0
2+	1683.8774	1683.8797	0.0023	49.9

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	6.56
Counter-ion (acetate)	ion chromatography	4.21
Residual solvent + inorganic residue	estimated	0.23
Total peptide content	by difference	89.00
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)	99.90	99.53	divergence +0.63 pp vs batch median
Total impurities (% area)	0.10	0.47
Largest single impurity (% area)	0.05	0.29
Water (%)	5.4	6.56
Counter-ion (%)	5.0	4.21
Peptide content (%w/w)	89.0	89.00
Endotoxin (EU/mg)	0.56	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: Domestic warehouse despatch → submitter (2–8 °C, 8 d) → laboratory (courier, cold pack, 3 d) → assay.
Assay date: 19 Mar 2025
Submitted to the index: 11 Apr 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.

wide_iqr11 Apr 2025

A single result at 99.53 % is one draw. What makes a supplier's process legible is the spread across its lots, and that is on the scorecard rather than here. This record is one good point in a distribution worth reading whole.

prep_hplc_cut11 Apr 2025

0.47 % total impurities on CJC-1295 (no DAC) means the preparative fraction was cut narrow. That trades yield for purity, and the trade was made in the buyer's favour on this lot.

uncertainty_budget11 Apr 2025

Nothing adverse on this record. Purity 99.53 %, largest single impurity native GRF (1-29) (−59 Da) at 0.29 %, and a mass balance that closes. It is a clean record and the index has no note to add to it.

Section 7

Related records

Same batch — lot FGP-2503-P8516 n=4

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-018834	FGP-2503-P8516	PeptideMeter	2025-Q1	99.42	6.35	—	Buyer-sourced	PASS
AX-2025-018836	FGP-2503-P8516	VendorInvestigate	2025-Q1	98.98	5.84	—	Buyer-sourced	PASS
AX-2025-018837	FGP-2503-P8516	Janoshik	2025-Q1	99.12	6.37	95.1	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 FGP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-041643	Semaglutide	FGP-2602-M8547	Janoshik	2026-Q3	99.31	2.79	100.7	Buyer-sourced	PASS
AX-2026-041638	Semaglutide	FGP-2602-M8547	Janoshik	2026-Q3	99.40	2.75	105.8	Buyer-sourced	PASS
AX-2026-041641	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	98.98	2.38	105.0	Buyer-sourced	PASS
AX-2026-041610	Tirzepatide	FGP-2603-L7753	Janoshik	2026-Q3	98.81	2.45	101.0	Buyer-sourced	PASS
AX-2026-041637	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	99.40	2.83	—	Laboratory-retained	PASS
AX-2026-041642	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	98.78	2.24	—	Buyer-sourced	PASS
AX-2026-041609	Tirzepatide	FGP-2603-L7753	Janoshik	2026-Q3	98.52	2.00	98.0	Buyer-sourced	PASS
AX-2026-041636	Semaglutide	FGP-2602-M8547	Nordanalyt	2026-Q3	99.39	2.17	—	Buyer-sourced	PASS