AX-2024-005543
NAD+ · 500 mg declared · Qingdao Saber Technology Pharmaceutical · lot QST-2402-B8115
- Report ID
- AX-2024-005543
- Compound
- NAD+
- Compound class
- Non-peptide adjuncts
- Supplier
- QST — Qingdao Saber Technology Pharmaceutical
- Batch / lot
- QST-2402-B8115
- Declared label claim
- 500mg
- Laboratory
- Nordanalyt Laboratories
- Assay date
- 16 Aug 2024
- Submitted
- 04 Sep 2024
- Quarter
- 2024-Q3
- Submitter
- n.brandt
- Sample provenance
- Supplier-supplied
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.
| Parameter | Method | Result | Unit | Index spec | |
|---|---|---|---|---|---|
| Purity | RP-HPLC, 35 min gradient, 214 nm | 98.39 | % area | ≥ 97.0 | PASS |
| Total impurities | RP-HPLC, sum of reported peaks | 1.61 | % area | ≤ 3.0 | PASS |
| Largest single impurity | RP-HPLC — ADP-ribose (−121 Da) | 0.66 | % area | ≤ 1.00 | PASS |
| Identity — theoretical monoisotopic mass | calculated from molecular formula | 663.1091 | Da | — | NOT TESTED |
| Identity — observed monoisotopic mass | LC-MS, high resolution (ESI-TOF/QTOF) | 663.1088 | Da | — | NOT TESTED |
| Mass accuracy | observed vs theoretical | -0.4 | ppm | ± 10 | PASS |
| Total peptide content | by difference from the gravimetric mass balance | 90.27 | %w/w | — | NOT TESTED |
| Target-compound content | total peptide content × purity | 88.82 | %w/w | — | NOT TESTED |
| Gross fill (as weighed) | five-place balance, under nitrogen | 603.55 | mg | 500 mg declared | NOT TESTED |
| Recovered target peptide | gross fill × target content | 536.073 | mg | 500 mg claim | NOT TESTED |
| Recovery against label claim | recovered ÷ claim | 107.2 | % | 90.0 – 110.0 | PASS |
| Water content | Karl Fischer, coulometric, duplicate | 8.83 | % | ≤ 10.0 | PASS |
| Counter-ion | no ionisable counter-ion expected | N/A | — | not applicable | NOT TESTED |
| Residual solvent + inorganic residue | estimated — see /methods/residual-solvents-q3c/ | 0.90 | % | — | NOT TESTED |
| Endotoxin | not ordered on this submission | not determined | — | ≤ 5.0 | NOT TESTED |
| Sterility | not ordered on this submission | not determined | — | no growth | NOT TESTED |
| Appearance | visual, diffuse light, black and white background | White cake, partial shrinkage from vial wall | — | white to off-white intact cake | FAIL |
| Reconstitution clarity | reconstituted per submitter procedure | Clear, colourless, no visible particulates | — | clear, no visible particulates | PASS |
| pH (reconstituted, 1 mg/mL) | potentiometric, two-point calibration | 6.38 | — | 2.5 – 8.0 | PASS |
| Retention time (observed) | RP-HPLC, 35 min gradient | 4.85 | min | 4.80 ± 0.25 (normalised) | PASS |
| Peak asymmetry (10 % height) | Ph. Eur. 2.2.46 | 1.13 | — | 0.80 – 1.50 | PASS |
| Plate count, main peak | N = 5.54 (t/w½)² | 67,576 | — | ≥ 20,000 | PASS |
| Resolution to nearest impurity | vs α-NAD anomer | 2.75 | — | no index criterion | REPORTED |
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.
| # | Peak | RT | Area (µV·s) | % area | Δ mass (Da) |
|---|---|---|---|---|---|
| 1 | NAD+ — main peak | 4.85 | 4,782,059 | 98.39 | — |
| 2 | ADP-ribose (−121 Da) | 4.55 | 32,078 | 0.66 | -121.040 |
| 3 | nicotinamide (−541 Da) | 4.06 | 29,648 | 0.61 | -541.052 |
| 4 | nicotinamide mononucleotide (NMN, −331 Da) | 4.36 | 8,263 | 0.17 | -331.058 |
| 5 | NADH (reduced, +2 Da) | 5.25 | 4,374 | 0.09 | +2.016 |
| 6 | α-NAD anomer | 5.06 | 3,888 | 0.08 | 0.000 |
| Closure check — purity + Σ impurities | 100.00 | CLOSES | |||
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.
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.
| Charge | Theoretical m/z | Observed m/z | Δ m/z | Rel. abundance (%) |
|---|---|---|---|---|
| 2+ | 332.5618 | 332.5617 | -0.0001 | 55.0 |
| 1+ | 664.1164 | 664.1161 | -0.0003 | 100.0 |
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.
| Component | Determination | %w/w of cake |
|---|---|---|
| Water | Karl Fischer | 8.83 |
| Counter-ion | none expected | 0.00 |
| Residual solvent + inorganic residue | estimated | 0.90 |
| Total peptide content | by difference | 90.27 |
| Total | 100.00 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.
| Figure | Supplier COA | This report | Index note |
|---|---|---|---|
| Purity (% area) | 98.05 | 98.39 | divergence +0.03 pp vs batch median |
| Total impurities (% area) | 1.95 | 1.61 | |
| Largest single impurity (% area) | 0.70 | 0.66 | |
| Water (%) | not stated | 8.83 | |
| Counter-ion (%) | 3.7 | N/A | |
| Peptide content (%w/w) | 92.2 | 90.27 | |
| Endotoxin (EU/mg) | 0.45 | not determined | |
| Method stated on certificate | YES | — | column, gradient and wavelength given |
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, 9 d) → assay. Submitter did not handle the vial.
- Assay date
- 16 Aug 2024
- Submitted to the index
- 04 Sep 2024
- Laboratory
- Nordanalyt Laboratories, Uppsala, Sweden
- Method basis
- 35 min gradient · high-resolution MS
- Verification status
- PARTIAL
Annotations
No annotations on this record. Annotations are short signed technical comments from index contributors; see how to contribute.
Related records
Same batch — lot QST-2402-B8115 n=6
| Report | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|
| AX-2024-005541 | QST-2402-B8115 | Nordanalyt | 2024-Q3 | 97.56 | 8.60 | — | Supplier-supplied | 0 | PASS |
| AX-2024-005542 | QST-2402-B8115 | PeptideMeter | 2024-Q3 | 97.66 | 8.82 | 104.3 | Buyer-sourced | 0 | PASS |
| AX-2024-005544 | QST-2402-B8115 | Nordanalyt | 2024-Q3 | 97.53 | 8.77 | 98.0 | Buyer-sourced | 0 | PASS |
| AX-2024-005545 | QST-2402-B8115 | Kestrel | 2024-Q3 | 98.37 | 8.65 | — | Supplier-supplied | 1 | FAIL |
| AX-2024-005546 | QST-2402-B8115 | Janoshik | 2024-Q3 | 98.80 | 8.87 | — | Supplier-supplied | 1 | FAIL |
Cross-sections
| Report | Supplier | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-041208 | WWB | WWB-2601-V1583 | VendorInvestigate | 2026-Q2 | 99.18 | 11.38 | 100.9 | Buyer-sourced | 0 | FAIL |
| AX-2026-041209 | WWB | WWB-2601-V1583 | Nordanalyt | 2026-Q2 | 99.82 | 11.64 | — | Supplier-supplied | 0 | FAIL |
| AX-2026-041210 | WWB | WWB-2601-V1583 | Nordanalyt | 2026-Q2 | 99.43 | 11.19 | 95.3 | Supplier-supplied | 0 | FAIL |
| AX-2026-042457 | SWB | SWB-2602-P5992 | PeptideMeter | 2026-Q2 | 99.06 | 10.72 | 96.8 | Supplier-supplied | 1 | FAIL |
| AX-2026-041211 | WWB | WWB-2601-V1583 | Janoshik | 2026-Q2 | 99.93 | 11.52 | 92.9 | Supplier-supplied | 0 | FAIL |
| AX-2026-042456 | SWB | SWB-2602-P5992 | Medutest | 2026-Q2 | 98.89 | 10.27 | 101.6 | Supplier-supplied | 2 | FAIL |
| AX-2026-041213 | WWB | WWB-2601-V1583 | VendorInvestigate | 2026-Q2 | 99.04 | 11.41 | — | Buyer-sourced | 0 | FAIL |
| AX-2026-042454 | SWB | SWB-2602-P5992 | Janoshik | 2026-Q2 | 98.64 | 11.21 | — | Supplier-supplied | 1 | FAIL |
| Report | Compound | Lot | Lab | Quarter | Purity % | Water % | Recovery % | Provenance | Flags | Result |
|---|---|---|---|---|---|---|---|---|---|---|
| AX-2026-043586 | MOTS-c | QST-2511-H7867 | PeptideMeter | 2026-Q2 | 98.06 | 5.19 | 97.7 | Supplier-supplied | 0 | PASS |
| AX-2026-043585 | GHRP-6 | QST-2508-M7961 | Janoshik | 2026-Q1 | 98.52 | 6.05 | 93.3 | Supplier-supplied | 1 | FAIL |
| AX-2024-005547 | Tirzepatide | QST-2409-K8302 | Janoshik | 2024-Q4 | 98.65 | 6.83 | 97.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005548 | Tirzepatide | QST-2409-K8302 | Janoshik | 2024-Q4 | 98.26 | 6.11 | 95.0 | Supplier-supplied | 1 | MARGINAL |
| AX-2024-005545 | NAD+ | QST-2402-B8115 | Kestrel | 2024-Q3 | 98.37 | 8.65 | — | Supplier-supplied | 1 | FAIL |
| AX-2024-005542 | NAD+ | QST-2402-B8115 | PeptideMeter | 2024-Q3 | 97.66 | 8.82 | 104.3 | Buyer-sourced | 0 | PASS |
| AX-2024-005546 | NAD+ | QST-2402-B8115 | Janoshik | 2024-Q3 | 98.80 | 8.87 | — | Supplier-supplied | 1 | FAIL |
| AX-2024-005541 | NAD+ | QST-2402-B8115 | Nordanalyt | 2024-Q3 | 97.56 | 8.60 | — | Supplier-supplied | 0 | PASS |