AX-2024-004785 · L-Carnosine · Homopeptide lot HOMO-2405-P5405

Section 1

Results

Measured against the index acceptance specification for the short bioregulator 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, 28 min gradient, 214 nm	99.88	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.12	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — β-alanine (−137 Da)	0.06	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	93.18	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	93.07	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	524.65	mg	500 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	488.292	mg	500 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	97.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	6.21	%	≤ 12.0	PASS
Counter-ion	no ionisable counter-ion expected	N/A	—	not applicable	NOT TESTED
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.61	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.40	EU/mg	≤ 5.0	PASS
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	8.00	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 28 min gradient	3.52	min	3.49 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.86	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	54,038	—	≥ 20,000	PASS
Resolution to nearest impurity	vs D-carnosine epimer	0.90	—	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, 28 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 54,038, and skew follows the reported asymmetry factor of 0.86. 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 0.06 % impurity against a 99.88 % 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	L-Carnosine — main peak	3.52	4,854,478	99.88	—
2	β-alanine (−137 Da)	3.31	2,916	0.06	-137.059
3	D-carnosine epimer	3.46	1,458	0.03	0.000
4	anserine (methylcarnosine, +14 Da)	3.63	1,458	0.03	+14.016
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 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	6.21
Counter-ion	none expected	0.00
Residual solvent + inorganic residue	estimated	0.61
Total peptide content	by difference	93.18
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	99.88	divergence +0.24 pp vs batch median
Total impurities (% area)	0.10	0.12
Largest single impurity (% area)	not stated	0.06
Water (%)	not stated	6.21
Counter-ion (%)	not stated	N/A
Peptide content (%w/w)	91.7	93.18
Endotoxin (EU/mg)	not stated	0.40
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, 2 d) → laboratory (courier, dry ice, 12 d) → assay.
Assay date: 04 Jun 2024
Submitted to the index: 07 Jun 2024
Laboratory: PeptideMeter, Tallinn, Estonia
Method basis: 28 min gradient · high-resolution MS
Verification status: METHOD LIMITED

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name 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.

lot_traceability07 Jun 2024

Lot HOMO-2405-P5405 decodes to a manufacture date consistent with the custody chain above. Traceability plus 99.88 % is a complete story; either alone is half of one.

hilic_hana07 Jun 2024

Nothing on this record is flagged for resolution and nothing will be. The figure exists so the reader can weight the purity number, which is its only purpose.

ash_sulfated07 Jun 2024

Inorganic residue from a buffer salt carried through the last lyophilisation is invisible on a chromatogram and obvious on an ash determination. It belongs in the residual slot.

Section 7

Related records

Same batch — lot HOMO-2405-P5405 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-004786	HOMO-2405-P5405	VendorInvestigate	2024-Q2	99.30	6.67	93.5	Buyer-sourced	PASS
AX-2024-004787	HOMO-2405-P5405	Janoshik	2024-Q2	99.38	6.76	—	Buyer-sourced	PASS
AX-2024-004788	HOMO-2405-P5405	Janoshik	2024-Q2	99.93	6.28	92.3	Buyer-sourced	PASS
AX-2024-004789	HOMO-2405-P5405	PeptideMeter	2024-Q2	99.46	6.32	90.6	Buyer-sourced	PASS
AX-2024-004790	HOMO-2405-P5405	Janoshik	2024-Q2	99.86	6.21	—	Buyer-sourced	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent L-Carnosine records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043257	CPC	CPC-2603-G9615	VendorInvestigate	2026-Q3	98.20	10.41	102.2	Buyer-sourced	0	FAIL
AX-2026-043256	CPC	CPC-2603-G9615	Janoshik	2026-Q3	99.02	10.17	104.1	Supplier-supplied	0	PASS
AX-2026-043258	CPC	CPC-2603-G9615	Medutest	2026-Q3	98.95	10.15	97.8	Buyer-sourced	0	FAIL
AX-2026-043189	GL Biochem	GLBI-2512-S8068	Medutest	2026-Q2	99.60	8.49	—	Buyer-sourced	0	PASS
AX-2026-043190	GL Biochem	GLBI-2512-S8068	Janoshik	2026-Q2	99.46	8.66	—	Buyer-sourced	0	PASS
AX-2026-043194	GL Biochem	GLBI-2512-S8068	Janoshik	2026-Q2	99.62	8.16	90.4	Buyer-sourced	0	PASS
AX-2026-043195	GL Biochem	GLBI-2512-S8068	Janoshik	2026-Q2	99.16	8.69	89.4	Laboratory-retained	1	MARGINAL
AX-2026-043188	GL Biochem	GLBI-2512-S8068	PeptideMeter	2026-Q2	99.62	8.43	—	Buyer-sourced	0	PASS

Other recent Homopeptide records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042437	Retatrutide	HOMO-2605-V4718	Nordanalyt	2026-Q3	98.68	3.67	102.8	Buyer-sourced	PASS
AX-2026-042424	Semaglutide	HOMO-2604-X3806	PeptideMeter	2026-Q3	98.85	4.87	92.0	Buyer-sourced	PASS
AX-2026-042503	IGF-1 LR3	HOMO-2607-P5131	Janoshik	2026-Q3	99.36	5.99	—	Buyer-sourced	PASS
AX-2026-042492	SS-31 (Elamipretide)	HOMO-2604-D5484	Medutest	2026-Q3	99.93	2.40	—	Buyer-sourced	PASS
AX-2026-042491	SS-31 (Elamipretide)	HOMO-2604-D5484	Kestrel	2026-Q3	99.93	3.24	—	Supplier-supplied	PASS
AX-2026-042473	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.01	5.00	—	Buyer-sourced	PASS
AX-2026-042441	Retatrutide	HOMO-2605-V4718	Medutest	2026-Q3	98.93	4.22	—	Buyer-sourced	PASS
AX-2026-042474	LL-37	HOMO-2602-G5165	Janoshik	2026-Q3	99.18	5.44	—	Buyer-sourced	PASS