AssayIndex

AX-2024-005323

NAD+ · 500 mg declared · Qingdao Saber Technology Pharmaceutical · lot QST-2402-B5599

PASSPARTIAL
Report ID
AX-2024-005323
Compound
NAD+
Compound class
Non-peptide adjuncts
Supplier
QST — Qingdao Saber Technology Pharmaceutical
Batch / lot
QST-2402-B5599
Declared label claim
500mg
Laboratory
Janoshik Analytical
Assay date
15 Sep 2024
Submitted
08 Oct 2024
Quarter
2024-Q3
Submitter
b.baptista
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, 30 min gradient, 214 nm97.81% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks2.19% area≤ 3.0PASS
Largest single impurityRP-HPLC — ADP-ribose (−121 Da)0.90% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula663.1091DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)663.1082DaNOT TESTED
Mass accuracyobserved vs theoretical-1.4ppm± 10PASS
Total peptide contentby difference from the gravimetric mass balance91.16%w/wNOT TESTED
Target-compound contenttotal peptide content × purity89.16%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen565.30mg500 mg declaredNOT TESTED
Recovered target peptidegross fill × target content504.021mg500 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim100.8%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate8.61%≤ 10.0PASS
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.23%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 cake, partially collapsedwhite 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 calibration7.122.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient4.18min4.16 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.460.860.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²87,504≥ 20,000PASS
Resolution to nearest impurityvs α-NAD anomer3.11no 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.

08434168682530233737 NAD+4.18 min · 97.81 % 3.50 same trace · ×50 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 87,504, and skew follows the reported asymmetry factor of 0.86. 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 0.90 % impurity against a 97.81 % 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 peak4.184,753,86997.81
2ADP-ribose (−121 Da)3.9243,7430.90-121.040
3nicotinamide (−541 Da)3.5040,3410.83-541.052
4nicotinamide mononucleotide (NMN, −331 Da)3.7611,6650.24-331.058
5NADH (reduced, +2 Da)4.525,8320.12+2.016
6α-NAD anomer4.364,8600.100.000
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 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 663.1082 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+332.5618332.5614-0.000458.6
1+664.1164664.1155-0.0009100.0
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 Fischer8.61
Counter-ionnone expected0.00
Residual solvent + inorganic residueestimated0.23
Total peptide contentby difference91.16
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)98.3197.81divergence +0.25 pp vs batch median
Total impurities (% area)1.692.19
Largest single impurity (% area)not stated0.90
Water (%)6.78.61
Counter-ion (%)not statedN/A
Peptide content (%w/w)not stated91.16
Endotoxin (EU/mg)0.38not 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
Buyer-sourced
Evidentiary weight
Strongest available evidence in this index.
Chain of custody
Retail purchase → submitter (ambient, 7 d) → laboratory (hand-carried, 5 d) → assay.
Assay date
15 Sep 2024
Submitted to the index
08 Oct 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 QST-2402-B5599 n=7

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-005317QST-2402-B5599Medutest2024-Q398.249.41106.1Buyer-sourced1FAIL
AX-2024-005318QST-2402-B5599PeptideMeter2024-Q397.618.7599.7Buyer-sourced0PASS
AX-2024-005319QST-2402-B5599Janoshik2024-Q398.179.40102.8Buyer-sourced0PASS
AX-2024-005320QST-2402-B5599Kestrel2024-Q398.068.5290.6Buyer-sourced0PASS
AX-2024-005321QST-2402-B5599Janoshik2024-Q397.988.28Buyer-sourced0PASS
AX-2024-005322QST-2402-B5599Nordanalyt2024-Q398.178.79Buyer-sourced0PASS
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 QST records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043498MOTS-cQST-2511-H5351Kestrel2026-Q298.365.08Buyer-sourced0PASS
AX-2026-043497GHRP-6QST-2508-M5445Janoshik2026-Q198.425.8297.2Buyer-sourced0FAIL
AX-2025-021111TirzepatideQST-2409-K5786Nordanalyt2024-Q498.846.4589.5Supplier-supplied1MARGINAL
AX-2025-021112TirzepatideQST-2409-K5786Janoshik2024-Q498.025.7898.6Buyer-sourced0PASS
AX-2024-005327TirzepatideQST-2409-K5786Janoshik2024-Q498.906.8197.8Supplier-supplied0PASS
AX-2024-005331TirzepatideQST-2409-K5786PeptideMeter2024-Q497.535.57Buyer-sourced0PASS
AX-2024-005330TirzepatideQST-2409-K5786Medutest2024-Q497.896.2591.3Buyer-sourced0PASS
AX-2024-005332TirzepatideQST-2409-K5786Nordanalyt2024-Q498.406.32Buyer-sourced0PASS