AssayIndex

AX-2024-004874

NAD+ · 1000 mg declared · Shanghai Wibson Biotechnology Co., Ltd. · lot SWB-2405-L5945

MARGINALPARTIAL
Report ID
AX-2024-004874
Compound
NAD+
Compound class
Non-peptide adjuncts
Supplier
SWB — Shanghai Wibson Biotechnology Co., Ltd.
Batch / lot
SWB-2405-L5945
Declared label claim
1000mg
Laboratory
Nordanalyt Laboratories
Assay date
25 Jul 2024
Submitted
31 Jul 2024
Quarter
2024-Q3
Submitter
m.kimani
Sample provenance
Supplier-supplied
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 nm98.84% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.16% area≤ 3.0PASS
Largest single impurityRP-HPLC — nicotinamide mononucleotide (NMN, −331 Da)0.54% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance90.11%w/wNOT TESTED
Target-compound contenttotal peptide content × purity89.06%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen1009.24mg1000 mg declaredNOT TESTED
Recovered target peptidegross fill × target content898.829mg1000 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim89.9%90.0 – 110.0FAIL
Water contentKarl Fischer, coulometric, duplicate9.60%≤ 10.0PASS
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.29%NOT TESTED
Endotoxinkinetic chromogenic LAL0.47EU/mg≤ 5.0PASS
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite powder, no defined cake (melt-back)white to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration7.352.5 – 8.0PASS
Retention time (observed)RP-HPLC, 35 min gradient4.79min4.80 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.080.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²44,070≥ 20,000PASS
Resolution to nearest impurityvs α-NAD anomer2.24no 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.

0482196431446419286 NAD+4.79 min · 98.84 % 4.30 same trace · ×100 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 44,070, and skew follows the reported asymmetry factor of 1.08. 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 0.54 % impurity against a 98.84 % 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 peak4.794,803,93098.84
2nicotinamide mononucleotide (NMN, −331 Da)4.3026,2460.54-331.058
3ADP-ribose (−121 Da)4.4916,5250.34-121.040
4NADH (reduced, +2 Da)5.195,3460.11+2.016
5nicotinamide (−541 Da)4.004,3740.09-541.052
6α-NAD anomer5.003,8880.080.000
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 Fischer9.60
Counter-ionnone expected0.00
Residual solvent + inorganic residueestimated0.29
Total peptide contentby difference90.11
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)99.3198.84divergence +0.34 pp vs batch median
Total impurities (% area)0.691.16
Largest single impurity (% area)not stated0.54
Water (%)7.89.60
Counter-ion (%)not statedN/A
Peptide content (%w/w)not stated90.11
Endotoxin (EU/mg)0.340.47
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
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 6 d) → assay. Submitter did not handle the vial.
Assay date
25 Jul 2024
Submitted to the index
31 Jul 2024
Laboratory
Nordanalyt Laboratories, Uppsala, Sweden
Method basis
35 min gradient · high-resolution MS
Verification status
PARTIAL
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 SWB-2405-L5945 n=8

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-004873SWB-2405-L5945Medutest2024-Q398.879.49105.2Supplier-supplied1FAIL
AX-2024-004875SWB-2405-L5945Janoshik2024-Q399.199.10Supplier-supplied0PASS
AX-2024-004876SWB-2405-L5945Janoshik2024-Q399.189.29Supplier-supplied0PASS
AX-2024-004877SWB-2405-L5945Nordanalyt2024-Q398.529.87100.2Buyer-sourced0PASS
AX-2024-004878SWB-2405-L5945Janoshik2024-Q399.079.30100.0Supplier-supplied0PASS
AX-2024-004879SWB-2405-L5945Medutest2024-Q399.689.3988.8Supplier-supplied2FAIL
AX-2024-004880SWB-2405-L5945Janoshik2024-Q398.659.0791.4Supplier-supplied0PASS
Other recent NAD+ records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041208WWBWWB-2601-V1583VendorInvestigate2026-Q299.1811.38100.9Buyer-sourced0FAIL
AX-2026-041209WWBWWB-2601-V1583Nordanalyt2026-Q299.8211.64Supplier-supplied0FAIL
AX-2026-041210WWBWWB-2601-V1583Nordanalyt2026-Q299.4311.1995.3Supplier-supplied0FAIL
AX-2026-042457SWBSWB-2602-P5992PeptideMeter2026-Q299.0610.7296.8Supplier-supplied1FAIL
AX-2026-041211WWBWWB-2601-V1583Janoshik2026-Q299.9311.5292.9Supplier-supplied0FAIL
AX-2026-042456SWBSWB-2602-P5992Medutest2026-Q298.8910.27101.6Supplier-supplied2FAIL
AX-2026-041213WWBWWB-2601-V1583VendorInvestigate2026-Q299.0411.41Buyer-sourced0FAIL
AX-2026-042454SWBSWB-2602-P5992Janoshik2026-Q298.6411.21Supplier-supplied1FAIL
Other recent SWB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042461Kisspeptin-10SWB-2603-D6238Janoshik2026-Q398.354.6596.5Supplier-supplied3FAIL
AX-2026-042479Melanotan IISWB-2603-A5707Janoshik2026-Q399.163.6794.5Supplier-supplied1MARGINAL
AX-2026-042481Melanotan IISWB-2603-A5707Medutest2026-Q398.953.3790.8Supplier-supplied1MARGINAL
AX-2026-042460Kisspeptin-10SWB-2603-D6238Kestrel2026-Q399.554.2190.8Supplier-supplied3MARGINAL
AX-2026-042483Melanotan IISWB-2603-A5707Janoshik2026-Q399.383.73107.2Supplier-supplied1MARGINAL
AX-2026-042398SemaglutideSWB-2602-X5278Nordanalyt2026-Q399.084.48Supplier-supplied1MARGINAL
AX-2026-042399SemaglutideSWB-2602-X5278Janoshik2026-Q398.563.82Supplier-supplied1MARGINAL
AX-2026-042499BPC-157SWB-2607-Y5787Kestrel2026-Q399.934.2594.4Supplier-supplied0PASS