AssayIndex

AX-2026-043626

L-Glutathione (reduced) · 600 mg declared · WuXi TIDES (WuXi AppTec Testing Division) · lot WXT-2605-B5720

FAILMETHOD LIMITED
Report ID
AX-2026-043626
Compound
L-Glutathione (reduced)
Compound class
Short bioregulator peptides
Supplier
WXT — WuXi TIDES (WuXi AppTec Testing Division)
Batch / lot
WXT-2605-B5720
Declared label claim
600mg
Laboratory
Medutest
Assay date
05 Aug 2026
Submitted
09 Aug 2026
Quarter
2026-Q3
Submitter
Contributor #H-9042
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 25 min gradient, 214 nm98.22% area≥ 98.5FAIL
Total impuritiesRP-HPLC, sum of reported peaks1.78% area≤ 1.5FAIL
Largest single impurityRP-HPLC — cysteinyl-glycine (−129 Da)0.87% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance93.40%w/wNOT TESTED
Target-compound contenttotal peptide content × purity91.74%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen655.85mg600 mg declaredNOT TESTED
Recovered target peptidegross fill × target content601.677mg600 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim100.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.33%≤ 12.0PASS
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.27%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration7.782.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient3.60min3.62 ± 0.20 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.120.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²73,657≥ 20,000PASS
Resolution to nearest impurityvs S-sulfonate adduct (+80 Da)2.15no index criterionREPORTED
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.

08086161722425832345 L-Glutathione (reduced)3.60 min · 98.22 % 3.40 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
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 73,657, 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 0.87 % impurity against a 98.22 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1L-Glutathione (reduced) — main peak3.604,773,79698.22
2cysteinyl-glycine (−129 Da)3.4042,2850.87-129.043
3γ-Glu-Cys (−57 Da)3.4525,2740.52-57.021
4glutathione disulfide (GSSG, +305 Da)4.0313,1230.27+304.984
5S-sulfonate adduct (+80 Da)3.485,8320.12+79.957
Closure check — purity + Σ impurities 100.00CLOSES

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.

ComponentDetermination%w/w of cake
WaterKarl Fischer6.33
Counter-ionnone expected0.00
Residual solvent + inorganic residueestimated0.27
Total peptide contentby difference93.40
Total100.00 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.

FigureSupplier COAThis reportIndex note
Purity (% area)98.098.22divergence -0.10 pp vs batch median
Total impurities (% area)2.001.78
Largest single impurity (% area)not stated0.87
Water (%)not stated6.33
Counter-ion (%)not statedN/A
Peptide content (%w/w)91.793.40
Endotoxin (EU/mg)0.72not determined
Method stated on certificateYEScolumn, 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, 12 d) → laboratory (courier, dry ice, 5 d) → assay.
Assay date
05 Aug 2026
Submitted to the index
09 Aug 2026
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
METHOD LIMITED
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.

valley_drop
Integration on this trace is unambiguous: cysteinyl-glycine (−129 Da) at 0.87 % is baseline-resolved from the main peak, so 98.22 % is a measurement rather than a boundary decision.
mass_defect
Before assigning cysteinyl-glycine (−129 Da) from retention alone, check the mass defect on the impurity peak. Plausible and implausible assignments separate cleanly and the check costs nothing.
deamidation_rate
Deamidation is time, temperature and sequence. If the deamidated species is prominent here, the manufacture date on lot WXT-2605-B5720 against the assay date above is the first arithmetic to do.
Section 7

Related records

Same batch — lot WXT-2605-B5720 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043620WXT-2605-B5720Kestrel2026-Q398.336.74101.9Buyer-sourced1FAIL
AX-2026-043621WXT-2605-B5720Kestrel2026-Q398.636.51105.3Buyer-sourced1MARGINAL
AX-2026-043622WXT-2605-B5720Janoshik2026-Q398.026.81Buyer-sourced1FAIL
AX-2026-043623WXT-2605-B5720VendorInvestigate2026-Q398.026.73106.2Laboratory-retained1FAIL
AX-2026-043624WXT-2605-B5720Nordanalyt2026-Q398.186.95105.3Buyer-sourced2FAIL
AX-2026-043625WXT-2605-B5720Janoshik2026-Q397.876.1090.7Buyer-sourced1FAIL
AX-2026-043627WXT-2605-B5720Janoshik2026-Q397.966.0892.3Buyer-sourced1FAIL
Other recent L-Glutathione (reduced) records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041873GSPGSP-2607-N3316Janoshik2026-Q398.457.5594.9Buyer-sourced1FAIL
AX-2026-041870GSPGSP-2607-N3316Nordanalyt2026-Q398.687.6590.5Buyer-sourced0PASS
AX-2026-043627WXTWXT-2605-B5720Janoshik2026-Q397.966.0892.3Buyer-sourced1FAIL
AX-2026-043624WXTWXT-2605-B5720Nordanalyt2026-Q398.186.95105.3Buyer-sourced2FAIL
AX-2026-043622WXTWXT-2605-B5720Janoshik2026-Q398.026.81Buyer-sourced1FAIL
AX-2026-043623WXTWXT-2605-B5720VendorInvestigate2026-Q398.026.73106.2Laboratory-retained1FAIL
AX-2026-041872GSPGSP-2607-N3316Medutest2026-Q398.507.78Buyer-sourced1MARGINAL
AX-2026-041875GSPGSP-2607-N3316Janoshik2026-Q398.697.45Buyer-sourced0PASS
Other recent WXT records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043651PramlintideWXT-2603-D6459PeptideMeter2026-Q398.214.97101.6Buyer-sourced1MARGINAL
AX-2026-043531LeuprolideWXT-2604-K4483Medutest2026-Q399.005.03Buyer-sourced0PASS
AX-2026-043561SemaglutideWXT-2604-C5135Janoshik2026-Q396.964.2291.3Buyer-sourced0FAIL
AX-2026-043627L-Glutathione (reduced)WXT-2605-B5720Janoshik2026-Q397.966.0892.3Buyer-sourced1FAIL
AX-2026-043564SemaglutideWXT-2604-C5135Janoshik2026-Q397.154.44104.7Buyer-sourced0PASS
AX-2026-043533LeuprolideWXT-2604-K4483PeptideMeter2026-Q399.894.94Supplier-supplied0PASS
AX-2026-043624L-Glutathione (reduced)WXT-2605-B5720Nordanalyt2026-Q398.186.95105.3Buyer-sourced2FAIL
AX-2026-043556SemaglutideWXT-2604-C5135PeptideMeter2026-Q397.564.3589.6Buyer-sourced1MARGINAL