AssayIndex

AX-2026-042022

L-Glutathione (reduced) · 200 mg declared · AmbioPharm, Inc. · lot AMB-2602-G6500

PASSMETHOD LIMITED
Report ID
AX-2026-042022
Compound
L-Glutathione (reduced)
Compound class
Short bioregulator peptides
Supplier
AMB — AmbioPharm, Inc.
Batch / lot
AMB-2602-G6500
Declared label claim
200mg
Laboratory
Janoshik Analytical
Assay date
31 Jan 2026
Submitted
17 Feb 2026
Quarter
2026-Q1
Submitter
ppm_error
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, 30 min gradient, 214 nm99.79% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.21% area≤ 1.5PASS
Largest single impurityRP-HPLC — glutathione disulfide (GSSG, +305 Da)0.10% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula307.0838DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)307.0843DaNOT TESTED
Mass accuracyobserved vs theoretical+1.5ppm± 20PASS
Total peptide contentby difference from the gravimetric mass balance92.11%w/wNOT TESTED
Target-compound contenttotal peptide content × purity91.92%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen198.76mg200 mg declaredNOT TESTED
Recovered target peptidegross fill × target content182.700mg200 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim91.4%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate7.61%≤ 12.0PASS
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.28%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 calibration7.952.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient4.34min4.28 ± 0.20 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.050.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²68,907≥ 20,000PASS
Resolution to nearest impurityvs S-sulfonate adduct (+80 Da)2.07no 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.

06816136332044927265 L-Glutathione (reduced)4.34 min · 99.79 % 4.86 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
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 68,907, and skew follows the reported asymmetry factor of 1.05. 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 0.10 % impurity against a 99.79 % 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 peak4.344,850,10399.79
2glutathione disulfide (GSSG, +305 Da)4.864,8600.10+304.984
3cysteinyl-glycine (−129 Da)4.103,4020.07-129.043
4S-sulfonate adduct (+80 Da)4.201,9440.04+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 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, high-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 307.0843 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+308.0911308.09160.0005100.0
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 Fischer7.61
Counter-ionnone expected0.00
Residual solvent + inorganic residueestimated0.28
Total peptide contentby difference92.11
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)99.9099.79divergence +0.11 pp vs batch median
Total impurities (% area)0.100.21
Largest single impurity (% area)not stated0.10
Water (%)6.77.61
Counter-ion (%)6.0N/A
Peptide content (%w/w)86.792.11
Endotoxin (EU/mg)not statednot 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 (ambient, 26 d) → laboratory (hand-carried, 3 d) → assay.
Assay date
31 Jan 2026
Submitted to the index
17 Feb 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-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.

des_gly
At 99.79 % the deletion-sequence family is at or below the reporting threshold. On a sequence with a hindered coupling that is a statement about coupling efficiency, and a good one.
plate_count
Plate count on this run supports the separation claimed. A high purity figure from an inefficient column is a merged peak reported as a clean one; that is not what happened here.
median_not_mean
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 AMB-2602-G6500 n=3

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042023AMB-2602-G6500Janoshik2026-Q199.657.5496.4Buyer-sourced0PASS
AX-2026-042024AMB-2602-G6500Janoshik2026-Q199.858.7898.6Buyer-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 AMB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042002SemaglutideAMB-2607-N6274VendorInvestigate2026-Q398.236.3797.1Buyer-sourced1MARGINAL
AX-2026-042012GHRP-6AMB-2603-S5667Janoshik2026-Q399.375.9088.8Laboratory-retained1MARGINAL
AX-2026-041974TirzepatideAMB-2603-C5112Nordanalyt2026-Q398.203.41Buyer-sourced0PASS
AX-2026-041975TirzepatideAMB-2603-C5112Medutest2026-Q397.883.45106.9Laboratory-retained0PASS
AX-2026-042005SemaglutideAMB-2607-N6274PeptideMeter2026-Q398.096.4898.6Buyer-sourced1MARGINAL
AX-2026-042008EpitalonAMB-2602-Y6433Janoshik2026-Q399.308.75105.1Buyer-sourced0PASS
AX-2026-042021TB-500AMB-2602-P5987VendorInvestigate2026-Q399.864.79101.4Buyer-sourced0PASS
AX-2026-042015GHRP-6AMB-2603-S5667Janoshik2026-Q399.546.4497.1Buyer-sourced0PASS