AX-2025-018942

L-Carnosine · 500 mg declared · Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. · lot FGP-2501-G1375

FAILPURITY ONLY

Report ID: AX-2025-018942
Compound: L-Carnosine
Compound class: Short bioregulator peptides
Supplier: FGP — Flourishglobal Peptide Biotech (Chengdu) Co., Ltd.
Batch / lot: FGP-2501-G1375
Declared label claim: 500mg
Laboratory: Nordanalyt Laboratories
Assay date: 24 Feb 2025
Submitted: 06 Mar 2025
Quarter: 2025-Q1
Submitter: fa.sjoberg
Sample provenance: Supplier-supplied

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, 35 min gradient, 214 nm	99.80	% area	≥ 99.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.20	% area	≤ 1.0	PASS
Largest single impurity	RP-HPLC — free histidine (−71 Da)	0.09	% 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	91.22	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	91.04	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	529.26	mg	500 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	481.838	mg	500 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	96.4	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	8.30	%	≤ 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/	0.48	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.84	EU/mg	≤ 5.0	PASS
Sterility	membrane filtration, USP <71>, 14 d	Growth detected at 6 d — Bacillus sp.	—	no growth	FAIL
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	7.06	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	4.26	min	4.29 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.12	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	70,175	—	≥ 20,000	PASS
Resolution to nearest impurity	vs D-carnosine epimer	1.06	—	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 70,175, and skew follows the reported asymmetry factor of 1.12. 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 0.09 % impurity against a 99.80 % 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	L-Carnosine — main peak	4.26	4,850,589	99.80	—
2	free histidine (−71 Da)	4.07	4,374	0.09	-71.037
3	D-carnosine epimer	4.19	2,916	0.06	0.000
4	anserine (methylcarnosine, +14 Da)	4.40	2,430	0.05	+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	8.30
Counter-ion	none expected	0.00
Residual solvent + inorganic residue	estimated	0.48
Total peptide content	by difference	91.22
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	99.80	divergence +0.02 pp vs batch median
Total impurities (% area)	0.10	0.20
Largest single impurity (% area)	0.04	0.09
Water (%)	7.8	8.30
Counter-ion (%)	not stated	N/A
Peptide content (%w/w)	not stated	91.22
Endotoxin (EU/mg)	0.43	0.84
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 5 d) → assay. Submitter did not handle the vial.
Assay date: 24 Feb 2025
Submitted to the index: 06 Mar 2025
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-resolution MS
Verification status: PURITY ONLY

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 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

No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.

Section 7

Related records

Same batch — lot FGP-2501-G1375 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-018937	FGP-2501-G1375	Nordanalyt	2025-Q1	99.57	8.41	—	Supplier-supplied	1	MARGINAL
AX-2025-018938	FGP-2501-G1375	Janoshik	2025-Q1	99.93	8.23	90.2	Supplier-supplied	0	PASS
AX-2025-018939	FGP-2501-G1375	Janoshik	2025-Q1	99.93	7.89	—	Supplier-supplied	0	PASS
AX-2025-018940	FGP-2501-G1375	Janoshik	2025-Q1	99.93	8.38	—	Supplier-supplied	0	PASS
AX-2025-018941	FGP-2501-G1375	Janoshik	2025-Q1	99.83	8.55	104.5	Supplier-supplied	0	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-2026-043283	CPC	CPC-2603-G1651	Medutest	2026-Q3	98.10	10.12	91.8	Supplier-supplied	1	FAIL
AX-2026-043289	CPC	CPC-2603-G1651	Janoshik	2026-Q3	98.01	10.52	—	Buyer-sourced	1	FAIL
AX-2026-043287	CPC	CPC-2603-G1651	Janoshik	2026-Q3	98.35	9.89	93.2	Supplier-supplied	2	FAIL
AX-2026-043286	CPC	CPC-2603-G1651	Janoshik	2026-Q3	98.53	10.02	—	Supplier-supplied	1	FAIL
AX-2026-043285	CPC	CPC-2603-G1651	Janoshik	2026-Q3	98.05	10.42	—	Supplier-supplied	1	FAIL
AX-2026-043288	CPC	CPC-2603-G1651	PeptideMeter	2026-Q3	99.03	9.94	105.1	Supplier-supplied	1	MARGINAL
AX-2026-043281	CPC	CPC-2603-G1651	Nordanalyt	2026-Q3	98.24	10.17	—	Supplier-supplied	1	FAIL
AX-2026-043282	CPC	CPC-2603-G1651	VendorInvestigate	2026-Q3	97.64	10.07	—	Buyer-sourced	1	FAIL

Other recent FGP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041742	Tirzepatide	FGP-2603-L9714	Janoshik	2026-Q3	99.37	2.43	105.5	Supplier-supplied	1	MARGINAL
AX-2026-041767	Semaglutide	FGP-2602-M1508	PeptideMeter	2026-Q3	98.65	2.54	—	Supplier-supplied	2	FAIL
AX-2026-041741	Tirzepatide	FGP-2603-L9714	PeptideMeter	2026-Q3	98.62	2.57	—	Supplier-supplied	1	MARGINAL
AX-2026-041772	Semaglutide	FGP-2602-M1508	Janoshik	2026-Q3	99.79	3.03	107.5	Supplier-supplied	0	PASS
AX-2026-041770	Semaglutide	FGP-2602-M1508	VendorInvestigate	2026-Q3	99.33	1.48	90.3	Buyer-sourced	1	MARGINAL
AX-2026-041769	Semaglutide	FGP-2602-M1508	Janoshik	2026-Q3	99.13	2.55	92.9	Supplier-supplied	1	MARGINAL
AX-2026-041768	Semaglutide	FGP-2602-M1508	Janoshik	2026-Q3	98.85	2.20	90.3	Supplier-supplied	1	MARGINAL
AX-2026-041771	Semaglutide	FGP-2602-M1508	Janoshik	2026-Q3	99.41	2.31	—	Supplier-supplied	0	PASS