AssayIndex

AX-2024-005542

NAD+ · 500 mg declared · Qingdao Saber Technology Pharmaceutical · lot QST-2402-B8115

PASSPARTIAL
Report ID
AX-2024-005542
Compound
NAD+
Compound class
Non-peptide adjuncts
Supplier
QST — Qingdao Saber Technology Pharmaceutical
Batch / lot
QST-2402-B8115
Declared label claim
500mg
Laboratory
PeptideMeter
Assay date
05 Sep 2024
Submitted
17 Sep 2024
Quarter
2024-Q3
Submitter
t.halvorsen
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, 28 min gradient, 214 nm97.66% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks2.34% area≤ 3.0PASS
Largest single impurityRP-HPLC — nicotinamide mononucleotide (NMN, −331 Da)0.95% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula663.1091DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)663.1065DaNOT TESTED
Mass accuracyobserved vs theoretical-3.9ppm± 10PASS
Total peptide contentby difference from the gravimetric mass balance90.57%w/wNOT TESTED
Target-compound contenttotal peptide content × purity88.45%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen589.40mg500 mg declaredNOT TESTED
Recovered target peptidegross fill × target content521.324mg500 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim104.3%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate8.82%≤ 10.0PASS
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.61%NOT TESTED
Endotoxinkinetic chromogenic LAL0.27EU/mg≤ 5.0PASS
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 after 90 s gentle swirling, no particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration6.942.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient3.86min3.90 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.900.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²74,357≥ 20,000PASS
Resolution to nearest impurityvs α-NAD anomer2.89no 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.

08406168132521933626 NAD+3.86 min · 97.66 % 3.47 same trace · ×50 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 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 74,357, and skew follows the reported asymmetry factor of 0.90. 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 0.95 % impurity against a 97.66 % 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 peak3.864,746,57997.66
2nicotinamide mononucleotide (NMN, −331 Da)3.4746,1730.95-331.058
3α-NAD anomer4.0342,7710.880.000
4NADH (reduced, +2 Da)4.1811,6650.24+2.016
5nicotinamide (−541 Da)3.239,2350.19-541.052
6ADP-ribose (−121 Da)3.623,8880.08-121.040
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+664.11[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 663.1065 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+332.5618332.5605-0.001349.9
1+664.1164664.1138-0.0026100.0
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 Fischer8.82
Counter-ionnone expected0.00
Residual solvent + inorganic residueestimated0.61
Total peptide contentby difference90.57
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)98.0597.66divergence +0.03 pp vs batch median
Total impurities (% area)1.952.34
Largest single impurity (% area)0.700.95
Water (%)not stated8.82
Counter-ion (%)3.7N/A
Peptide content (%w/w)92.290.57
Endotoxin (EU/mg)0.450.27
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 → third-party forwarder (3 d) → laboratory (courier, cold pack, 2 d) → assay.
Assay date
05 Sep 2024
Submitted to the index
17 Sep 2024
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 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 QST-2402-B8115 n=6

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-005541QST-2402-B8115Nordanalyt2024-Q397.568.60Supplier-supplied0PASS
AX-2024-005543QST-2402-B8115Nordanalyt2024-Q398.398.83107.2Supplier-supplied0PASS
AX-2024-005544QST-2402-B8115Nordanalyt2024-Q397.538.7798.0Buyer-sourced0PASS
AX-2024-005545QST-2402-B8115Kestrel2024-Q398.378.65Supplier-supplied1FAIL
AX-2024-005546QST-2402-B8115Janoshik2024-Q398.808.87Supplier-supplied1FAIL
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 QST records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043586MOTS-cQST-2511-H7867PeptideMeter2026-Q298.065.1997.7Supplier-supplied0PASS
AX-2026-043585GHRP-6QST-2508-M7961Janoshik2026-Q198.526.0593.3Supplier-supplied1FAIL
AX-2024-005547TirzepatideQST-2409-K8302Janoshik2024-Q498.656.8397.0Supplier-supplied1MARGINAL
AX-2024-005548TirzepatideQST-2409-K8302Janoshik2024-Q498.266.1195.0Supplier-supplied1MARGINAL
AX-2024-005545NAD+QST-2402-B8115Kestrel2024-Q398.378.65Supplier-supplied1FAIL
AX-2024-005546NAD+QST-2402-B8115Janoshik2024-Q398.808.87Supplier-supplied1FAIL
AX-2024-005543NAD+QST-2402-B8115Nordanalyt2024-Q398.398.83107.2Supplier-supplied0PASS
AX-2024-005541NAD+QST-2402-B8115Nordanalyt2024-Q397.568.60Supplier-supplied0PASS