AX-2024-004955 · GHRP-2 · MKM lot MKM-2405-A3531

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, 32 min gradient, 214 nm	98.80	% area	≥ 99.0	FAIL
Total impurities	RP-HPLC, sum of reported peaks	1.20	% area	≤ 1.0	FAIL
Largest single impurity	RP-HPLC — C-terminal free acid (+1 Da)	0.52	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	817.4275	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	817.4267	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	-1.0	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	86.87	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.83	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	2.07	mg	2 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.777	mg	2 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	88.9	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	6.26	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.10	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.77	%	—	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	5.53	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 32 min gradient	9.61	min	9.62 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.09	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	54,712	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-2-Nal]-epimer	0.89	—	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, 32 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 54,712, and skew follows the reported asymmetry factor of 1.09. 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 0.52 % impurity against a 98.80 % 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	GHRP-2 — main peak	9.61	4,801,986	98.80	—
2	C-terminal free acid (+1 Da)	9.78	25,274	0.52	+0.984
3	oxidised Trp (+16 Da)	9.23	21,871	0.45	+15.995
4	[D-2-Nal]-epimer	9.46	5,832	0.12	0.000
5	des-Lys (−128 Da)	9.35	5,346	0.11	-128.095
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 817.4275 Da, computed from C45H55N9O6. 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 817.4267 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 (%)
2+	409.7210	409.7206	-0.0004	57.6
1+	818.4348	818.4340	-0.0008	100.0

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	6.26
Counter-ion (acetate)	ion chromatography	6.10
Residual solvent + inorganic residue	estimated	0.77
Total peptide content	by difference	86.87
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)	99.23	98.80	divergence +0.43 pp vs batch median
Total impurities (% area)	not stated	1.20
Largest single impurity (% area)	not stated	0.52
Water (%)	5.3	6.26
Counter-ion (%)	9.1	6.10
Peptide content (%w/w)	85.0	86.87
Endotoxin (EU/mg)	0.17	not determined
Method stated on certificate	NO	—	no method section — the result cannot be reconciled against any other

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, 18 d) → laboratory (courier, dry ice, 12 d) → assay.
Assay date: 19 Nov 2024
Submitted to the index: 13 Dec 2024
Laboratory: VendorInvestigate, Riga, Latvia
Method basis: 32 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.

oxidation_ladder13 Dec 2024

If the dominant species is an oxidation product the finding is about handling; if it is a deletion or a diastereomer the finding is about synthesis. On this record it is C-terminal free acid (+1 Da), which settles the question.

hplc_ola13 Dec 2024

Column temperature shifts selectivity by a few percent per ten degrees on peptides. Where two peaks are this close that is enough to matter and it is rarely on the report.

label_claim13 Dec 2024

Rule AX-R06 fires below 90 % and above 110 % of claim. It is the index's own tolerance and it is wider than any pharmacopoeial requirement would be.

Section 7

Related records

Same batch — lot MKM-2405-A3531 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 GHRP-2 records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043535	SIG	SIG-2603-6031	Janoshik	2026-Q3	99.12	1.26	105.7	Buyer-sourced	0	PASS
AX-2026-043541	SIG	SIG-2603-6031	PeptideMeter	2026-Q3	99.06	2.08	107.4	Buyer-sourced	1	MARGINAL
AX-2026-043539	SIG	SIG-2603-6031	Janoshik	2026-Q3	98.95	1.74	100.4	Buyer-sourced	1	FAIL
AX-2026-043534	SIG	SIG-2603-6031	Medutest	2026-Q3	99.11	2.15	89.8	Buyer-sourced	1	MARGINAL
AX-2026-043542	SIG	SIG-2603-6031	VendorInvestigate	2026-Q3	99.05	1.43	—	Buyer-sourced	1	FAIL
AX-2026-043543	SIG	SIG-2603-6031	Janoshik	2026-Q3	99.38	1.70	98.6	Buyer-sourced	0	PASS
AX-2026-043544	SIG	SIG-2603-6031	PeptideMeter	2026-Q3	99.57	1.51	105.4	Buyer-sourced	0	PASS
AX-2026-043538	SIG	SIG-2603-6031	Kestrel	2026-Q3	98.93	1.72	—	Buyer-sourced	0	FAIL

Other recent MKM records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042942	CJC-1295 (no DAC)	MKM-2603-V3346	Janoshik	2026-Q3	99.52	3.43	—	Supplier-supplied	PASS
AX-2026-043019	Adipotide	MKM-2606-K5012	Janoshik	2026-Q3	97.61	5.77	105.1	Buyer-sourced	PASS
AX-2026-042939	CJC-1295 (no DAC)	MKM-2603-V3346	PeptideMeter	2026-Q3	99.44	3.39	—	Buyer-sourced	PASS
AX-2026-043020	Adipotide	MKM-2606-K5012	Medutest	2026-Q3	97.73	5.74	—	Buyer-sourced	PASS
AX-2026-043022	Adipotide	MKM-2606-K5012	Kestrel	2026-Q3	97.69	6.33	106.9	Buyer-sourced	PASS
AX-2026-043023	Adipotide	MKM-2606-K5012	Medutest	2026-Q3	97.48	5.56	103.7	Supplier-supplied	PASS
AX-2026-042945	CJC-1295 (no DAC)	MKM-2603-V3346	PeptideMeter	2026-Q3	99.39	3.54	—	Laboratory-retained	PASS
AX-2026-042938	CJC-1295 (no DAC)	MKM-2603-V3346	Nordanalyt	2026-Q3	99.47	3.67	95.0	Buyer-sourced	PASS