AssayIndex

AX-2024-005369

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

PASSMETHOD LIMITED
Report ID
AX-2024-005369
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
Kestrel Bioanalytical
Assay date
26 May 2024
Submitted
28 May 2024
Quarter
2024-Q2
Submitter
c.okafor
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, 15 min gradient, 214 nm99.29% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.71% area≤ 1.5PASS
Largest single impurityRP-HPLC — S-sulfonate adduct (+80 Da)0.32% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula307.0838DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)307.0818DaNOT TESTED
Mass accuracyobserved vs theoretical-6.6ppm± 20PASS
Total peptide contentby difference from the gravimetric mass balance90.62%w/wNOT TESTED
Target-compound contenttotal peptide content × purity89.98%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen630.40mg600 mg declaredNOT TESTED
Recovered target peptidegross fill × target content567.234mg600 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim94.5%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate8.49%≤ 12.0PASS
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.89%NOT TESTED
Endotoxinkinetic chromogenic LAL0.18EU/mg≤ 5.0PASS
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundOff-white lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureFaint haze, clearing on standingclear, no visible particulatesFAIL
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration7.272.5 – 8.0PASS
Retention time (observed)RP-HPLC, 15 min gradient2.12min2.31 ± 0.20 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.280.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²36,514≥ 20,000PASS
Resolution to nearest impurityvs S-sulfonate adduct (+80 Da)1.54no 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.

09087181752726236350 L-Glutathione (reduced)2.12 min · 99.29 % 2.05 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 048121620 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 15 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 36,514, and skew follows the reported asymmetry factor of 1.28. 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 0.32 % impurity against a 99.29 % 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 peak2.124,825,80299.29
2S-sulfonate adduct (+80 Da)2.0515,5530.32+79.957
3glutathione disulfide (GSSG, +305 Da)2.3812,1510.25+304.984
4cysteinyl-glycine (−129 Da)2.004,8600.10-129.043
5γ-Glu-Cys (−57 Da)2.031,9440.04-57.021
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 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.

0255075100275300325350375400 [M+1H]1+308.09 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 307.0818 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.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
1+308.0911308.0891-0.0020100.0
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer8.49
Counter-ionnone expected0.00
Residual solvent + inorganic residueestimated0.89
Total peptide contentby difference90.62
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)99.2799.29divergence -0.19 pp vs batch median
Total impurities (% area)0.730.71
Largest single impurity (% area)0.450.32
Water (%)not stated8.49
Counter-ion (%)7.4N/A
Peptide content (%w/w)88.590.62
Endotoxin (EU/mg)not stated0.18
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
Domestic warehouse despatch → submitter (2–8 °C, 24 d) → laboratory (courier, cold pack, 4 d) → assay.
Assay date
26 May 2024
Submitted to the index
28 May 2024
Laboratory
Kestrel Bioanalytical, Melbourne, Australia
Method basis
15 min gradient · unit-resolution MS
Verification status
METHOD LIMITED
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 PPG-2312-C7508 n=11

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-005368PPG-2312-C7508Janoshik2024-Q299.428.31101.6Buyer-sourced0FAIL
AX-2024-005370PPG-2312-C7508Janoshik2024-Q299.438.10104.9Buyer-sourced0PASS
AX-2024-005371PPG-2312-C7508Janoshik2024-Q299.518.46Laboratory-retained0PASS
AX-2024-005372PPG-2312-C7508Janoshik2024-Q299.548.72Buyer-sourced0PASS
AX-2024-005373PPG-2312-C7508Janoshik2024-Q299.468.62Laboratory-retained0PASS
AX-2024-005374PPG-2312-C7508Janoshik2024-Q299.748.06Buyer-sourced0PASS
AX-2024-005375PPG-2312-C7508PeptideMeter2024-Q299.408.00Buyer-sourced0PASS
AX-2024-005376PPG-2312-C7508PeptideMeter2024-Q299.167.7989.3Buyer-sourced1MARGINAL
AX-2024-005377PPG-2312-C7508PeptideMeter2024-Q299.548.88104.6Buyer-sourced0PASS
AX-2024-005378PPG-2312-C7508Medutest2024-Q299.887.6490.1Buyer-sourced0PASS
Other recent L-Glutathione (reduced) records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043429WXTWXT-2605-B3833Nordanalyt2026-Q398.486.5896.9Supplier-supplied1FAIL
AX-2026-043424WXTWXT-2605-B3833PeptideMeter2026-Q398.376.86Buyer-sourced0FAIL
AX-2026-043166GL BiochemGLBI-2606-S7352Janoshik2026-Q399.018.84105.4Laboratory-retained1MARGINAL
AX-2026-043423WXTWXT-2605-B3833Janoshik2026-Q397.866.6693.4Buyer-sourced0FAIL
AX-2026-043426WXTWXT-2605-B3833Kestrel2026-Q398.836.32Supplier-supplied1MARGINAL
AX-2026-043425WXTWXT-2605-B3833Janoshik2026-Q398.776.35Supplier-supplied1MARGINAL
AX-2026-043431WXTWXT-2605-B3833Nordanalyt2026-Q397.946.18Buyer-sourced0FAIL
AX-2026-043427WXTWXT-2605-B3833Medutest2026-Q397.676.08Buyer-sourced1FAIL
Other recent PPG records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043598TesamorelinPPG-2608-A6835Kestrel2026-Q398.912.56100.3Buyer-sourced1FAIL
AX-2026-043597TesamorelinPPG-2608-A6835Janoshik2026-Q398.541.15Buyer-sourced0PASS
AX-2026-043596TesamorelinPPG-2608-A6835PeptideMeter2026-Q398.741.83105.1Buyer-sourced1MARGINAL
AX-2026-043605RetatrutidePPG-2604-X7060Janoshik2026-Q298.174.2999.7Buyer-sourced0PASS
AX-2026-043601RetatrutidePPG-2604-X7060Janoshik2026-Q298.283.9695.3Buyer-sourced0PASS
AX-2026-043668AOD-9604PPG-2602-W8018PeptideMeter2026-Q299.473.06Buyer-sourced0PASS
AX-2026-043670AOD-9604PPG-2602-W8018PeptideMeter2026-Q299.562.71104.5Buyer-sourced0PASS
AX-2026-043630CJC-1295 (no DAC)PPG-2512-D7211Janoshik2026-Q299.665.1192.5Buyer-sourced0PASS