AX-2024-004479

L-Glutathione (reduced) · 200 mg declared · Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. · lot FGP-2408-K1521

PASSMETHOD LIMITED

Report ID: AX-2024-004479
Compound: L-Glutathione (reduced)
Compound class: Short bioregulator peptides
Supplier: FGP — Flourishglobal Peptide Biotech (Chengdu) Co., Ltd.
Batch / lot: FGP-2408-K1521
Declared label claim: 200mg
Laboratory: Janoshik Analytical
Assay date: 18 Sep 2024
Submitted: 10 Oct 2024
Quarter: 2024-Q3
Submitter: l.falk
Sample provenance: Laboratory-retained

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	99.57	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.43	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — S-sulfonate adduct (+80 Da)	0.19	% 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)	307.0847	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.9	ppm	± 20	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	6.77	%	≤ 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/	0.45	%	—	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	8.20	—	2.5 – 8.0	FAIL
Retention time (observed)	RP-HPLC, 30 min gradient	4.33	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	39,110	—	≥ 20,000	PASS
Resolution to nearest impurity	vs S-sulfonate adduct (+80 Da)	1.56	—	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 39,110, 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 0.19 % impurity against a 99.57 % 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	4.33	4,839,411	99.57	—
2	S-sulfonate adduct (+80 Da)	4.19	9,235	0.19	+79.957
3	glutathione disulfide (GSSG, +305 Da)	4.85	4,860	0.10	+304.984
4	cysteinyl-glycine (−129 Da)	4.09	3,888	0.08	-129.043
5	γ-Glu-Cys (−57 Da)	4.15	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 307.0847 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	308.0920	0.0009	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.

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	99.57	divergence +0.02 pp vs batch median
Total impurities (% area)	0.10	0.43
Largest single impurity (% area)	not stated	0.19
Water (%)	5.6	6.77
Counter-ion (%)	not stated	N/A
Peptide content (%w/w)	89.6	not determined
Endotoxin (EU/mg)	not stated	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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 19 d since original receipt) → re-assay.
Assay date: 18 Sep 2024
Submitted to the index: 10 Oct 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: METHOD LIMITED

What this report does not establish

How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
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

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-2408-K1521 n=9

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004476	FGP-2408-K1521	Janoshik	2024-Q3	99.93	6.79	—	Supplier-supplied	0	PASS
AX-2024-004477	FGP-2408-K1521	Janoshik	2024-Q3	99.61	7.16	89.8	Supplier-supplied	1	MARGINAL
AX-2024-004478	FGP-2408-K1521	PeptideMeter	2024-Q3	99.88	6.34	100.1	Supplier-supplied	0	PASS
AX-2024-004480	FGP-2408-K1521	Medutest	2024-Q3	99.93	7.01	92.9	Supplier-supplied	0	PASS
AX-2024-004481	FGP-2408-K1521	Nordanalyt	2024-Q3	99.88	6.62	105.7	Supplier-supplied	0	PASS
AX-2024-004482	FGP-2408-K1521	Medutest	2024-Q3	99.80	7.55	—	Supplier-supplied	0	PASS
AX-2024-004483	FGP-2408-K1521	Medutest	2024-Q3	99.93	7.03	97.7	Supplier-supplied	0	PASS
AX-2024-004484	FGP-2408-K1521	Medutest	2024-Q3	99.93	6.77	99.8	Supplier-supplied	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

All L-Glutathione (reduced) records n=122
All FGP records n=296
All Janoshik records n=3159
All 2024-Q3 records n=522
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-2026-043166	GL Biochem	GLBI-2606-S7722	PeptideMeter	2026-Q3	99.26	8.52	107.1	Supplier-supplied	1	MARGINAL
AX-2026-043461	WXT	WXT-2605-B5313	PeptideMeter	2026-Q3	97.39	6.92	102.2	Supplier-supplied	0	FAIL
AX-2026-042932	MKM	MKM-2511-F2902	Janoshik	2026-Q2	98.57	8.41	92.9	Supplier-supplied	1	MARGINAL
AX-2026-043399	WXT	WXT-2512-P4300	PeptideMeter	2026-Q2	98.07	8.72	—	Supplier-supplied	1	FAIL
AX-2026-042337	HJ	HJ-2511-F3082	Janoshik	2026-Q2	99.93	7.58	—	Supplier-supplied	0	PASS
AX-2026-042930	MKM	MKM-2511-F2902	Janoshik	2026-Q2	98.42	7.82	97.4	Supplier-supplied	1	FAIL
AX-2026-042336	HJ	HJ-2511-F3082	Janoshik	2026-Q2	99.93	7.34	—	Supplier-supplied	0	PASS
AX-2026-042338	HJ	HJ-2511-F3082	Kestrel	2026-Q2	99.93	6.73	—	Supplier-supplied	0	PASS

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