AX-2024-004459 · Mazdutide · SinoPep lot SNP-2408-A4044

Section 1

Results

Measured against the index acceptance specification for the incretin analogues and co-agonists 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	99.29	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.71	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — des-Aib2 analogue	0.50	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	4912.6408	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	4912.6437	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+0.6	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	89.64	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	89.00	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	4.68	mg	4 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.165	mg	4 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	104.1	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.01	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	5.54	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.81	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	1.07	EU/mg	≤ 5.0	PASS
Sterility	not ordered on this submission	not determined	—	no growth	NOT TESTED
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	3.19	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	19.52	min	19.42 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.11	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	62,946	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib2]-diastereomer	0.66	—	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 62,946, and skew follows the reported asymmetry factor of 1.11. 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 0.50 % impurity against a 99.29 % 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	Mazdutide — main peak	19.52	4,825,802	99.29	—
2	des-Aib2 analogue	19.13	24,302	0.50	-85.053
3	truncated (4-39)	17.78	6,804	0.14	-315.169
4	oxidised Met (+16 Da)	18.82	1,458	0.03	+15.995
5	[D-Aib2]-diastereomer	19.31	972	0.02	0.000
6	trifluoroacetyl adduct (+96 Da)	20.42	972	0.02	+95.982
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 4912.6408 Da, computed from C226H352N50O70. 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 4912.6437 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 (%)
7+	702.8131	702.8135	0.0004	8.5
6+	819.7807	819.7812	0.0005	55.7
5+	983.5354	983.5360	0.0006	100.0
4+	1229.1675	1229.1682	0.0007	56.4
3+	1638.5542	1638.5552	0.0010	9.2

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.

Component	Determination	%w/w of cake
Water	Karl Fischer	4.01
Counter-ion (TFA)	ion chromatography	5.54
Residual solvent + inorganic residue	estimated	0.81
Total peptide content	by difference	89.64
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)	98.68	99.29	divergence -0.04 pp vs batch median
Total impurities (% area)	1.32	0.71
Largest single impurity (% area)	0.67	0.50
Water (%)	2.0	4.01
Counter-ion (%)	not stated	5.54
Peptide content (%w/w)	not stated	89.64
Endotoxin (EU/mg)	not stated	1.07
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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 4 d) → assay. Submitter did not handle the vial.
Assay date: 17 Jul 2024
Submitted to the index: 04 Aug 2024
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: VERIFIED

What this report does not establish

That the material is sterile. Sterility was not tested.
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.

lambda_21404 Aug 2024

Detection wavelength does not affect a mass determination but it does affect the purity figure sitting next to it. Both are stated on this record, which is the point.

dedupe_logic04 Aug 2024

If a supplier-supplied and a buyer-sourced result on SNP-2408-A4044 both exist, they are two observations of one lot and the batch page pairs them. That pairing is the strongest evidence structure this index produces.

Section 7

Related records

Same batch — lot SNP-2408-A4044 n=4

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2024-004456	SNP-2408-A4044	VendorInvestigate	2024-Q3	97.59	3.42	95.8	Buyer-sourced	PASS
AX-2024-004457	SNP-2408-A4044	PeptideMeter	2024-Q3	98.51	3.35	91.5	Buyer-sourced	PASS
AX-2024-004458	SNP-2408-A4044	Janoshik	2024-Q3	98.92	3.58	—	Buyer-sourced	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Mazdutide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042930	MKM	MKM-2511-N3837	Janoshik	2026-Q2	98.08	7.96	—	Buyer-sourced	1	MARGINAL
AX-2026-042923	MKM	MKM-2511-N3837	Janoshik	2026-Q2	98.46	6.72	97.9	Buyer-sourced	0	PASS
AX-2026-042928	MKM	MKM-2511-N3837	Janoshik	2026-Q2	98.59	6.41	—	Buyer-sourced	0	PASS
AX-2026-042926	MKM	MKM-2511-N3837	Nordanalyt	2026-Q2	98.67	6.63	93.6	Buyer-sourced	0	PASS
AX-2026-041921	SinoPep	SNP-2602-U4281	Janoshik	2026-Q2	98.21	4.18	92.9	Buyer-sourced	1	MARGINAL
AX-2026-041920	SinoPep	SNP-2602-U4281	Janoshik	2026-Q2	97.77	4.41	88.7	Buyer-sourced	2	MARGINAL
AX-2026-043118	SSA	SSA-2605-G6892	PeptideMeter	2026-Q2	98.96	3.25	98.7	Buyer-sourced	0	PASS
AX-2026-042924	MKM	MKM-2511-N3837	Nordanalyt	2026-Q2	98.78	7.43	—	Buyer-sourced	0	PASS

Other recent SinoPep records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041867	CJC-1295 with DAC	SNP-2607-C3886	Janoshik	2026-Q3	99.24	5.12	—	Laboratory-retained	1	FAIL
AX-2026-041913	Ipamorelin	SNP-2606-L4478	PeptideMeter	2026-Q3	98.88	5.28	—	Buyer-sourced	0	FAIL
AX-2026-041914	Ipamorelin	SNP-2606-L4478	Janoshik	2026-Q3	99.14	5.49	—	Buyer-sourced	0	PASS
AX-2026-041909	Ipamorelin	SNP-2606-L4478	PeptideMeter	2026-Q3	99.00	5.48	89.5	Buyer-sourced	1	MARGINAL
AX-2026-041895	Ipamorelin	SNP-2602-B3833	Janoshik	2026-Q3	99.93	4.72	105.9	Buyer-sourced	1	MARGINAL
AX-2026-041930	IGF-1 LR3	SNP-2606-D4620	Medutest	2026-Q3	98.54	5.37	93.8	Buyer-sourced	0	PASS
AX-2026-041898	Ipamorelin	SNP-2602-B3833	Nordanalyt	2026-Q3	99.93	4.54	96.0	Buyer-sourced	1	MARGINAL
AX-2026-041931	IGF-1 LR3	SNP-2606-D4620	PeptideMeter	2026-Q3	97.93	5.19	93.4	Buyer-sourced	0	PASS