AssayIndex

AX-2025-019135

NAD+ · 100 mg declared · GenScript Biotech Corporation · lot GSP-2507-A3926

FAILPARTIAL
Report ID
AX-2025-019135
Compound
NAD+
Compound class
Non-peptide adjuncts
Supplier
GSP — GenScript Biotech Corporation
Batch / lot
GSP-2507-A3926
Declared label claim
100mg
Laboratory
Nordanalyt Laboratories
Assay date
30 Jul 2025
Submitted
17 Aug 2025
Quarter
2025-Q3
Submitter
ka.marchand
Sample provenance
Buyer-sourced
Section 1

Results

Measured against the index acceptance specification for the non-peptide adjuncts class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 35 min gradient, 214 nm99.33% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.67% area≤ 3.0PASS
Largest single impurityRP-HPLC — nicotinamide mononucleotide (NMN, −331 Da)0.24% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula663.1091DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)663.0805DaNOT TESTED
Mass accuracyobserved vs theoretical-43.1ppm± 10FAIL
Total peptide contentby difference from the gravimetric mass balance87.90%w/wNOT TESTED
Target-compound contenttotal peptide content × purity87.31%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen109.19mg100 mg declaredNOT TESTED
Recovered target peptidegross fill × target content95.334mg100 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim95.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate11.67%≤ 10.0FAIL
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.43%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 to pale-yellow 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 calibration7.242.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient4.80min4.80 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.150.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²68,145≥ 20,000PASS
Resolution to nearest impurityvs α-NAD anomer2.79no 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.

05817116341745123268 NAD+4.80 min · 99.33 % 4.31 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0510152025303540 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 35 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 68,145, and skew follows the reported asymmetry factor of 1.15. 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 0.24 % impurity against a 99.33 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1NAD+ — main peak4.804,827,74699.33
2nicotinamide mononucleotide (NMN, −331 Da)4.3111,6650.24-331.058
3nicotinamide (−541 Da)4.0110,2070.21-541.052
4α-NAD anomer5.016,3180.130.000
5NADH (reduced, +2 Da)5.202,4300.05+2.016
6ADP-ribose (−121 Da)4.501,9440.04-121.040
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 663.1091 Da, computed from C21H27N7O14P2. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100275350425500575650725 [M+1H]1+664.09[M+2H]2+332.55 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 663.0805 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 (%)
2+332.5618332.5475-0.014356.6
1+664.1164664.0878-0.0286100.0
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 Fischer11.67
Counter-ionnone expected0.00
Residual solvent + inorganic residueestimated0.43
Total peptide contentby difference87.90
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)99.2699.33divergence +0.17 pp vs batch median
Total impurities (% area)0.740.67
Largest single impurity (% area)not stated0.24
Water (%)9.611.67
Counter-ion (%)4.9N/A
Peptide content (%w/w)84.987.90
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 (−20 °C, 5 d) → laboratory (courier, dry ice, 11 d) → assay.
Assay date
30 Jul 2025
Submitted to the index
17 Aug 2025
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
PARTIAL
Section 6

Annotations 4

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.

gradient_25
The gradient is on the record, which is the first thing that should be true of any purity figure and often is not. 35 min at Nordanalyt puts this comparison on a documented footing.
buyer_sourced
Buyer-sourced through an ordinary retail order, so the supplier had no opportunity to select the vial. This is the provenance class the index weights and it is roughly 87 % of the dataset.
bland_altman
Where two laboratories tested the same retail lot, the paired difference is a clean estimate of inter-lab bias with no selection term in it at all. Those pairs are the backbone of the agreement analysis.
iso_audit
A certification says what a process is supposed to do. A retail vial says what it did. Both are worth having and only one of them is a measurement.
Section 7

Related records

Same batch — lot GSP-2507-A3926 n=2

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2025-019134GSP-2507-A3926Janoshik2025-Q398.8411.68Buyer-sourced0FAIL
Other recent NAD+ records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041208WWBWWB-2601-V1583VendorInvestigate2026-Q299.4711.38100.9Buyer-sourced0FAIL
AX-2026-041209WWBWWB-2601-V1583Nordanalyt2026-Q299.4711.40106.7Buyer-sourced0FAIL
AX-2026-041210WWBWWB-2601-V1583Nordanalyt2026-Q299.6611.0191.9Buyer-sourced0FAIL
AX-2026-041211WWBWWB-2601-V1583Janoshik2026-Q299.7210.9493.5Buyer-sourced0FAIL
AX-2026-041213WWBWWB-2601-V1583VendorInvestigate2026-Q299.3311.41Buyer-sourced0FAIL
AX-2026-041212WWBWWB-2601-V1583Janoshik2026-Q299.9310.3688.5Laboratory-retained1FAIL
AX-2025-019628TFCTFC-2505-C1792Janoshik2025-Q399.7211.1992.6Buyer-sourced0FAIL
AX-2025-019134GSPGSP-2507-A3926Janoshik2025-Q398.8411.68Buyer-sourced0FAIL
Other recent GSP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041831SurvodutideGSP-2603-E3156Kestrel2026-Q399.915.5093.2Buyer-sourced0PASS
AX-2026-041836SurvodutideGSP-2603-E3156Janoshik2026-Q398.655.3490.3Buyer-sourced0PASS
AX-2026-041837SurvodutideGSP-2603-E3156Janoshik2026-Q398.335.37Buyer-sourced0PASS
AX-2026-041833SurvodutideGSP-2603-E3156Janoshik2026-Q398.084.9199.3Buyer-sourced0PASS
AX-2026-041832SurvodutideGSP-2603-E3156VendorInvestigate2026-Q398.015.1499.5Buyer-sourced0PASS
AX-2026-041835SurvodutideGSP-2603-E3156Nordanalyt2026-Q398.345.7489.0Buyer-sourced1MARGINAL
AX-2026-041834SurvodutideGSP-2603-E3156VendorInvestigate2026-Q397.925.95Buyer-sourced0PASS
AX-2026-041838SurvodutideGSP-2603-E3156PeptideMeter2026-Q398.305.01102.4Buyer-sourced0PASS