AssayIndex

AX-2024-005163

NAD+ · 1000 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2409-Y5476

FAILPARTIAL
Report ID
AX-2024-005163
Compound
NAD+
Compound class
Non-peptide adjuncts
Supplier
KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot
KP-2409-Y5476
Declared label claim
1000mg
Laboratory
Janoshik Analytical
Assay date
29 Oct 2024
Submitted
14 Nov 2024
Quarter
2024-Q4
Submitter
b.vukovic
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, 30 min gradient, 214 nm99.48% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.52% area≤ 3.0PASS
Largest single impurityRP-HPLC — ADP-ribose (−121 Da)0.22% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula663.1091DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)663.1103DaNOT TESTED
Mass accuracyobserved vs theoretical+1.8ppm± 10PASS
Total peptide contentby difference from the gravimetric mass balance87.47%w/wNOT TESTED
Target-compound contenttotal peptide content × purity87.02%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen1128.82mg1000 mg declaredNOT TESTED
Recovered target peptidegross fill × target content982.299mg1000 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim98.2%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate11.62%≤ 10.0FAIL
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.91%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 calibration6.502.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient4.35min4.16 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.050.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²72,311≥ 20,000PASS
Resolution to nearest impurityvs ADP-ribose (−121 Da)3.92no 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.

06945138902083527780 NAD+4.35 min · 99.48 % 3.67 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 72,311, 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 0.22 % impurity against a 99.48 % 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 peak4.354,835,03699.48
2ADP-ribose (−121 Da)4.0910,6930.22-121.040
3nicotinamide (−541 Da)3.679,7210.20-541.052
4nicotinamide mononucleotide (NMN, −331 Da)3.933,4020.07-331.058
5NADH (reduced, +2 Da)4.691,4580.03+2.016
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+664.12[M+2H]2+332.56 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 663.1103 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+332.5618332.56240.000658.1
1+664.1164664.11760.0012100.0
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 Fischer11.62
Counter-ionnone expected0.00
Residual solvent + inorganic residueestimated0.91
Total peptide contentby difference87.47
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)99.7399.48divergence +0.55 pp vs batch median
Total impurities (% area)0.270.52
Largest single impurity (% area)not stated0.22
Water (%)10.411.62
Counter-ion (%)not statedN/A
Peptide content (%w/w)not stated87.47
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNOno method section — the result cannot be reconciled against any other
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, 5 d) → assay. Submitter did not handle the vial.
Assay date
29 Oct 2024
Submitted to the index
14 Nov 2024
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 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 KP-2409-Y5476 n=3

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-005164KP-2409-Y5476PeptideMeter2024-Q499.1811.7988.5Supplier-supplied1FAIL
AX-2024-005165KP-2409-Y5476VendorInvestigate2024-Q498.6011.9299.1Buyer-sourced0FAIL
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 KP records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043029RetatrutideKP-2607-H5219Medutest2026-Q395.455.71Supplier-supplied2FAIL
AX-2026-043030RetatrutideKP-2607-H5219Kestrel2026-Q395.976.9597.1Supplier-supplied2FAIL
AX-2026-043106TirzepatideKP-2608-D5921PeptideMeter2026-Q398.905.45105.4Supplier-supplied2MARGINAL
AX-2026-043108TirzepatideKP-2608-D5921Janoshik2026-Q399.705.45Supplier-supplied2MARGINAL
AX-2026-043039RetatrutideKP-2607-H5219Janoshik2026-Q396.145.62Supplier-supplied2FAIL
AX-2026-043100TirzepatideKP-2608-D5921VendorInvestigate2026-Q398.275.3194.4Buyer-sourced2MARGINAL
AX-2026-043090IpamorelinKP-2606-D5887Janoshik2026-Q398.183.07101.2Laboratory-retained1FAIL
AX-2026-043028RetatrutideKP-2607-H5219Janoshik2026-Q396.526.09Supplier-supplied2MARGINAL