AX-2025-019430 · L-Glutathione (reduced) · HYB lot HYB-2502-S7614

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, 25 min gradient, 214 nm	99.41	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.59	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — cysteinyl-glycine (−129 Da)	0.27	% 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	91.43	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	90.89	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	199.74	mg	200 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	181.544	mg	200 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	90.8	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	8.23	%	≤ 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/	0.34	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	1.39	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	Off-white lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	6.77	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	3.80	min	3.62 ± 0.20 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.18	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	80,979	—	≥ 20,000	PASS
Resolution to nearest impurity	vs S-sulfonate adduct (+80 Da)	2.13	—	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, 25 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 80,979, and skew follows the reported asymmetry factor of 1.18. 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 0.27 % impurity against a 99.41 % 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-Glutathione (reduced) — main peak	3.80	4,831,634	99.41	—
2	cysteinyl-glycine (−129 Da)	3.60	13,123	0.27	-129.043
3	glutathione disulfide (GSSG, +305 Da)	4.23	7,290	0.15	+304.984
4	S-sulfonate adduct (+80 Da)	3.68	4,860	0.10	+79.957
5	γ-Glu-Cys (−57 Da)	3.65	3,402	0.07	-57.021
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	8.23
Counter-ion	none expected	0.00
Residual solvent + inorganic residue	estimated	0.34
Total peptide content	by difference	91.43
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)	99.34	99.41	divergence -0.05 pp vs batch median
Total impurities (% area)	0.66	0.59
Largest single impurity (% area)	0.46	0.27
Water (%)	6.6	8.23
Counter-ion (%)	5.3	N/A
Peptide content (%w/w)	87.5	91.43
Endotoxin (EU/mg)	0.73	1.39
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 (2–8 °C, 9 d) → laboratory (courier, ambient, 9 d) → assay.
Assay date: 02 May 2025
Submitted to the index: 16 May 2025
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-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 2

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_traceability16 May 2025

Lot HYB-2502-S7614 decodes to a manufacture date consistent with the custody chain above. Traceability plus 99.41 % is a complete story; either alone is half of one.

median_not_mean16 May 2025

One result at the top of the distribution should not move anybody's estimate much on its own. Purity distributions are compressed at the top and long-tailed at the bottom, so the informative observations are the low ones.

Section 7

Related records

Same batch — lot HYB-2502-S7614 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019423	HYB-2502-S7614	Janoshik	2025-Q2	99.27	8.33	90.1	Buyer-sourced	0	PASS
AX-2025-019424	HYB-2502-S7614	Janoshik	2025-Q2	99.82	7.92	90.8	Buyer-sourced	0	PASS
AX-2025-019425	HYB-2502-S7614	Janoshik	2025-Q2	99.33	8.75	—	Buyer-sourced	0	PASS
AX-2025-019426	HYB-2502-S7614	Nordanalyt	2025-Q2	99.35	8.00	—	Buyer-sourced	0	PASS
AX-2025-019427	HYB-2502-S7614	Janoshik	2025-Q2	99.37	8.56	95.7	Buyer-sourced	0	PASS
AX-2025-019428	HYB-2502-S7614	Nordanalyt	2025-Q2	99.50	8.59	94.6	Buyer-sourced	0	PASS
AX-2025-019429	HYB-2502-S7614	Janoshik	2025-Q2	99.73	8.40	—	Buyer-sourced	0	PASS
AX-2025-019431	HYB-2502-S7614	Nordanalyt	2025-Q2	99.59	8.66	—	Buyer-sourced	1	FAIL
AX-2025-019432	HYB-2502-S7614	Janoshik	2025-Q2	99.18	8.18	—	Buyer-sourced	0	PASS
AX-2025-019433	HYB-2502-S7614	Nordanalyt	2025-Q2	99.47	8.54	—	Buyer-sourced	0	PASS
AX-2025-019434	HYB-2502-S7614	VendorInvestigate	2025-Q2	99.37	9.11	—	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

All L-Glutathione (reduced) records n=129
All HYB records n=241
All Medutest records n=934
All 2025-Q2 records n=619
L-Glutathione (reduced) by supplier
L-Glutathione (reduced) impurity profile

Other recent L-Glutathione (reduced) records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043429	WXT	WXT-2605-B3833	Nordanalyt	2026-Q3	98.48	6.58	96.9	Supplier-supplied	1	FAIL
AX-2026-043424	WXT	WXT-2605-B3833	PeptideMeter	2026-Q3	98.37	6.86	—	Buyer-sourced	0	FAIL
AX-2026-043166	GL Biochem	GLBI-2606-S7352	Janoshik	2026-Q3	99.01	8.84	105.4	Laboratory-retained	1	MARGINAL
AX-2026-043423	WXT	WXT-2605-B3833	Janoshik	2026-Q3	97.86	6.66	93.4	Buyer-sourced	0	FAIL
AX-2026-043426	WXT	WXT-2605-B3833	Kestrel	2026-Q3	98.83	6.32	—	Supplier-supplied	1	MARGINAL
AX-2026-043425	WXT	WXT-2605-B3833	Janoshik	2026-Q3	98.77	6.35	—	Supplier-supplied	1	MARGINAL
AX-2026-043431	WXT	WXT-2605-B3833	Nordanalyt	2026-Q3	97.94	6.18	—	Buyer-sourced	0	FAIL
AX-2026-043427	WXT	WXT-2605-B3833	Medutest	2026-Q3	97.67	6.08	—	Buyer-sourced	1	FAIL

Other recent HYB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042083	MOTS-c	HYB-2606-D7858	Medutest	2026-Q3	99.93	2.02	—	Buyer-sourced	0	PASS
AX-2026-042090	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.57	2.36	—	Buyer-sourced	1	FAIL
AX-2026-042084	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.28	2.79	107.3	Buyer-sourced	0	PASS
AX-2026-042087	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.54	3.05	—	Buyer-sourced	0	PASS
AX-2026-042085	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.51	2.31	—	Buyer-sourced	0	PASS
AX-2026-042088	MOTS-c	HYB-2606-D7858	PeptideMeter	2026-Q3	99.22	2.21	—	Buyer-sourced	0	PASS
AX-2026-042086	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.93	3.02	—	Buyer-sourced	1	MARGINAL
AX-2026-042091	CJC-1295 with DAC	HYB-2608-E7391	Janoshik	2026-Q3	99.38	5.53	—	Buyer-sourced	0	PASS