AX-2025-019134 · NAD+ · GSP lot GSP-2507-A3926

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.

Parameter	Method	Result	Unit	Index spec
Purity	RP-HPLC, 30 min gradient, 214 nm	98.84	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.16	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — nicotinamide (−541 Da)	0.55	% 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
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	11.68	%	≤ 10.0	FAIL
Counter-ion	no ionisable counter-ion expected	N/A	—	not applicable	NOT TESTED
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.18	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
Sterility	membrane filtration, USP <71>, 14 d	No growth at 14 d	—	no growth	PASS
Appearance	visual, diffuse light, black and white background	White lyophilised cake, intact	—	white to off-white intact cake	PASS
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	7.10	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	4.09	min	4.16 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.86	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	67,456	—	≥ 20,000	PASS
Resolution to nearest impurity	vs α-NAD anomer	2.79	—	no index criterion	REPORTED

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.

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 67,456, 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 0.55 % impurity against a 98.84 % main peak is a line two pixels tall; the main peak runs off-scale there by design.

#	Peak	RT	Area (µV·s)	% area	Δ mass (Da)
1	NAD+ — main peak	4.09	4,803,930	98.84	—
2	nicotinamide (−541 Da)	3.41	26,732	0.55	-541.052
3	α-NAD anomer	4.27	17,011	0.35	0.000
4	nicotinamide mononucleotide (NMN, −331 Da)	3.67	6,804	0.14	-331.058
5	NADH (reduced, +2 Da)	4.43	3,888	0.08	+2.016
6	ADP-ribose (−121 Da)	3.83	1,944	0.04	-121.040
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.

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.

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 663.1088 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.

Charge	Theoretical m/z	Observed m/z	Δ m/z	Rel. abundance (%)
2+	332.5618	332.5617	-0.0001	51.2
1+	664.1164	664.1161	-0.0003	100.0

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.

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)	99.26	98.84	divergence +0.17 pp vs batch median
Total impurities (% area)	0.74	1.16
Largest single impurity (% area)	not stated	0.55
Water (%)	9.6	11.68
Counter-ion (%)	4.9	N/A
Peptide content (%w/w)	84.9	not determined
Endotoxin (EU/mg)	not stated	not determined
Method stated on certificate	YES	—	column, 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 → submitter (2–8 °C, 32 d) → laboratory (courier, ambient, 12 d) → assay.
Assay date: 23 Sep 2025
Submitted to the index: 27 Sep 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PARTIAL

What this report does not establish

How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
That the material is free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
That any other vial in the same lot has the same composition. One vial was tested. Within-lot vial-to-vial variation in this index has a median of 0.28 pp and a 90th percentile of 0.74 pp.
That any other lot from the same supplier has the same composition. Batch-to-batch variation is larger than within-batch variation for every supplier here.
That the material is suitable for administration to a human or an animal. These are research compounds. No result on this site is a safety assessment and the index takes no position on use.
That the material was manufactured by the supplier that sold it. Contract synthesis is normal in this market and twenty-nine batches in the index fingerprint to a bulk from a different company than the one named on the label.

Section 6

Annotations 2

Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.

iqr_watcher27 Sep 2025

The index specification is stated on the class page with its source and its reasoning. A record outside it is outside a documented threshold, which is a very different thing from a regulatory status.

spec_vs_result27 Sep 2025

A threshold that nothing ever fails is not measuring anything. Publishing the failure rate for each specification is how a reader can judge whether the threshold is calibrated.

Section 7

Related records

Same batch — lot GSP-2507-A3926 n=2

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2025-019135	GSP-2507-A3926	Nordanalyt	2025-Q3	99.33	11.67	95.3	Buyer-sourced	1	FAIL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent NAD+ records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041208	WWB	WWB-2601-V1583	VendorInvestigate	2026-Q2	99.47	11.38	100.9	Buyer-sourced	0	FAIL
AX-2026-041209	WWB	WWB-2601-V1583	Nordanalyt	2026-Q2	99.47	11.40	106.7	Buyer-sourced	0	FAIL
AX-2026-041210	WWB	WWB-2601-V1583	Nordanalyt	2026-Q2	99.66	11.01	91.9	Buyer-sourced	0	FAIL
AX-2026-041211	WWB	WWB-2601-V1583	Janoshik	2026-Q2	99.72	10.94	93.5	Buyer-sourced	0	FAIL
AX-2026-041213	WWB	WWB-2601-V1583	VendorInvestigate	2026-Q2	99.33	11.41	—	Buyer-sourced	0	FAIL
AX-2026-041212	WWB	WWB-2601-V1583	Janoshik	2026-Q2	99.93	10.36	88.5	Laboratory-retained	1	FAIL
AX-2025-019628	TFC	TFC-2505-C1792	Janoshik	2025-Q3	99.72	11.19	92.6	Buyer-sourced	0	FAIL
AX-2025-019149	GSP	GSP-2503-B3620	Janoshik	2025-Q3	99.83	9.91	92.2	Buyer-sourced	0	PASS

Other recent GSP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041831	Survodutide	GSP-2603-E3156	Kestrel	2026-Q3	99.91	5.50	93.2	Buyer-sourced	0	PASS
AX-2026-041836	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.65	5.34	90.3	Buyer-sourced	0	PASS
AX-2026-041837	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.33	5.37	—	Buyer-sourced	0	PASS
AX-2026-041833	Survodutide	GSP-2603-E3156	Janoshik	2026-Q3	98.08	4.91	99.3	Buyer-sourced	0	PASS
AX-2026-041832	Survodutide	GSP-2603-E3156	VendorInvestigate	2026-Q3	98.01	5.14	99.5	Buyer-sourced	0	PASS
AX-2026-041835	Survodutide	GSP-2603-E3156	Nordanalyt	2026-Q3	98.34	5.74	89.0	Buyer-sourced	1	MARGINAL
AX-2026-041834	Survodutide	GSP-2603-E3156	VendorInvestigate	2026-Q3	97.92	5.95	—	Buyer-sourced	0	PASS
AX-2026-041838	Survodutide	GSP-2603-E3156	PeptideMeter	2026-Q3	98.30	5.01	102.4	Buyer-sourced	0	PASS