AX-2024-005370

L-Glutathione (reduced) · 600 mg declared · PolyPeptide Group (Hangzhou) Co., Ltd. · lot PPG-2312-C7508

PASSMETHOD LIMITED

Report ID: AX-2024-005370
Compound: L-Glutathione (reduced)
Compound class: Short bioregulator peptides
Supplier: PPG — PolyPeptide Group (Hangzhou) Co., Ltd.
Batch / lot: PPG-2312-C7508
Declared label claim: 600mg
Laboratory: Janoshik Analytical
Assay date: 05 Jun 2024
Submitted: 20 Jun 2024
Quarter: 2024-Q2
Submitter: charge_envelope
Sample provenance: Buyer-sourced

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, 30 min gradient, 214 nm	99.43	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.57	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — glutathione disulfide (GSSG, +305 Da)	0.20	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	307.0838	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	307.0848	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+3.4	ppm	± 20	PASS
Total peptide content	by difference from the gravimetric mass balance	91.37	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	90.85	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	693.11	mg	600 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	629.690	mg	600 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	104.9	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	8.10	%	≤ 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/	0.53	%	—	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 to pale-yellow cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	7.37	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	4.31	min	4.28 ± 0.20 (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	56,133	—	≥ 20,000	PASS
Resolution to nearest impurity	vs S-sulfonate adduct (+80 Da)	1.88	—	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 56,133, 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 0.20 % impurity against a 99.43 % 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	4.31	4,832,606	99.43	—
2	glutathione disulfide (GSSG, +305 Da)	4.83	9,721	0.20	+304.984
3	cysteinyl-glycine (−129 Da)	4.07	9,235	0.19	-129.043
4	S-sulfonate adduct (+80 Da)	4.17	5,832	0.12	+79.957
5	γ-Glu-Cys (−57 Da)	4.13	2,916	0.06	-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 3

Mass spectrum and identity

Theoretical monoisotopic mass 307.0838 Da, computed from C10H17N3O6S. 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 307.0848 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 (%)
1+	308.0911	308.0921	0.0010	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	8.10
Counter-ion	none expected	0.00
Residual solvent + inorganic residue	estimated	0.53
Total peptide content	by difference	91.37
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)	99.27	99.43	divergence -0.19 pp vs batch median
Total impurities (% area)	0.73	0.57
Largest single impurity (% area)	0.45	0.20
Water (%)	not stated	8.10
Counter-ion (%)	7.4	N/A
Peptide content (%w/w)	88.5	91.37
Endotoxin (EU/mg)	not stated	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: Retail purchase → submitter (ambient, 23 d) → laboratory (courier, cold pack, 4 d) → assay.
Assay date: 05 Jun 2024
Submitted to the index: 20 Jun 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: METHOD LIMITED

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 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.

ms_confirm20 Jun 2024

Purity at 99.43 % with identity confirmed on the same submission is the combination worth having. Either alone leaves a question the other answers.

isotope_cluster20 Jun 2024

Nothing here rules out a positional isomer with the same formula. Mass cannot; only chromatography can, and the gradient length on this record is the relevant fact for that.

Section 7

Related records

Same batch — lot PPG-2312-C7508 n=11

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005368	PPG-2312-C7508	Janoshik	2024-Q2	99.42	8.31	101.6	Buyer-sourced	0	FAIL
AX-2024-005369	PPG-2312-C7508	Kestrel	2024-Q2	99.29	8.49	94.5	Buyer-sourced	0	PASS
AX-2024-005371	PPG-2312-C7508	Janoshik	2024-Q2	99.51	8.46	—	Laboratory-retained	0	PASS
AX-2024-005372	PPG-2312-C7508	Janoshik	2024-Q2	99.54	8.72	—	Buyer-sourced	0	PASS
AX-2024-005373	PPG-2312-C7508	Janoshik	2024-Q2	99.46	8.62	—	Laboratory-retained	0	PASS
AX-2024-005374	PPG-2312-C7508	Janoshik	2024-Q2	99.74	8.06	—	Buyer-sourced	0	PASS
AX-2024-005375	PPG-2312-C7508	PeptideMeter	2024-Q2	99.40	8.00	—	Buyer-sourced	0	PASS
AX-2024-005376	PPG-2312-C7508	PeptideMeter	2024-Q2	99.16	7.79	89.3	Buyer-sourced	1	MARGINAL
AX-2024-005377	PPG-2312-C7508	PeptideMeter	2024-Q2	99.54	8.88	104.6	Buyer-sourced	0	PASS
AX-2024-005378	PPG-2312-C7508	Medutest	2024-Q2	99.88	7.64	90.1	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

All L-Glutathione (reduced) records n=129
All PPG records n=213
All Janoshik records n=2989
All 2024-Q2 records n=287
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 PPG records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043598	Tesamorelin	PPG-2608-A6835	Kestrel	2026-Q3	98.91	2.56	100.3	Buyer-sourced	1	FAIL
AX-2026-043597	Tesamorelin	PPG-2608-A6835	Janoshik	2026-Q3	98.54	1.15	—	Buyer-sourced	0	PASS
AX-2026-043596	Tesamorelin	PPG-2608-A6835	PeptideMeter	2026-Q3	98.74	1.83	105.1	Buyer-sourced	1	MARGINAL
AX-2026-043605	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.17	4.29	99.7	Buyer-sourced	0	PASS
AX-2026-043601	Retatrutide	PPG-2604-X7060	Janoshik	2026-Q2	98.28	3.96	95.3	Buyer-sourced	0	PASS
AX-2026-043668	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.47	3.06	—	Buyer-sourced	0	PASS
AX-2026-043670	AOD-9604	PPG-2602-W8018	PeptideMeter	2026-Q2	99.56	2.71	104.5	Buyer-sourced	0	PASS
AX-2026-043630	CJC-1295 (no DAC)	PPG-2512-D7211	Janoshik	2026-Q2	99.66	5.11	92.5	Buyer-sourced	0	PASS