AX-2024-005092

Mazdutide · 4 mg declared · Shanghai Sigma-Audley New Material Technology Co., Ltd. · lot SSA-2407-L7018

PASSIDENTITY CONSISTENT

Report ID: AX-2024-005092
Compound: Mazdutide
Compound class: Incretin analogues and co-agonists
Supplier: SSA — Shanghai Sigma-Audley New Material Technology Co., Ltd.
Batch / lot: SSA-2407-L7018
Declared label claim: 4mg
Laboratory: Medutest
Assay date: 31 Oct 2024
Submitted: 23 Nov 2024
Quarter: 2024-Q4
Submitter: Contributor #T-8990
Sample provenance: Buyer-sourced

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, 25 min gradient, 214 nm	96.98	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	3.02	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — trifluoroacetyl adduct (+96 Da)	1.59	% area	≤ 1.00	FAIL
Identity — theoretical monoisotopic mass	calculated from molecular formula	4912.6408	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	4912.6634	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+4.6	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	88.73	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	86.05	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	4.73	mg	4 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.070	mg	4 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	101.8	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.20	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	6.48	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.59	%	—	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	3.26	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 25 min gradient	16.48	min	16.44 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.03	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	60,725	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib2]-diastereomer	0.64	—	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, 25 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 60,725, and skew follows the reported asymmetry factor of 1.03. 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 1.59 % impurity against a 96.98 % 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	16.48	4,713,529	96.98	—
2	trifluoroacetyl adduct (+96 Da)	17.23	77,279	1.59	+95.982
3	truncated (4-39)	15.03	48,117	0.99	-315.169
4	des-Aib2 analogue	16.16	13,609	0.28	-85.053
5	oxidised Met (+16 Da)	15.90	4,860	0.10	+15.995
6	[D-Aib2]-diastereomer	16.30	2,916	0.06	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.

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, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 4912.6634 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	702.8163	0.0032	8.5
6+	819.7807	819.7845	0.0038	55.5
5+	983.5354	983.5400	0.0046	100.0
4+	1229.1675	1229.1731	0.0056	55.0
3+	1638.5542	1638.5617	0.0075	8.5

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	4.20
Counter-ion (TFA)	ion chromatography	6.48
Residual solvent + inorganic residue	estimated	0.59
Total peptide content	by difference	88.73
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)	96.59	96.98	divergence -0.39 pp vs batch median
Total impurities (% area)	not stated	3.02
Largest single impurity (% area)	not stated	1.59
Water (%)	not stated	4.20
Counter-ion (%)	not stated	6.48
Peptide content (%w/w)	not stated	88.73
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 (−20 °C, 11 d) → laboratory (courier, dry ice, 7 d) → assay.
Assay date: 31 Oct 2024
Submitted to the index: 23 Nov 2024
Laboratory: Medutest, Ljubljana, Slovenia
Method basis: 25 min gradient · unit-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
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.

ms_confirm23 Nov 2024

A reference standard on the same sequence would upgrade this from a good mass to a traceable one. The distinction matters where a result is going to be cited rather than merely read.

spec_vs_result23 Nov 2024

A balance that closes says nothing about whether any of the four values is within specification. Consistency and compliance are different properties and this record demonstrates the first.

Section 7

Related records

Same batch — lot SSA-2407-L7018 n=1

This is the only report on this lot. One report is not a batch characterisation.

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 SSA records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043135	BPC-157	SSA-2601-N6863	Nordanalyt	2026-Q2	98.16	4.66	92.8	Buyer-sourced	1	MARGINAL
AX-2026-043160	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.01	4.02	91.8	Buyer-sourced	0	PASS
AX-2026-043157	GHK-Cu	SSA-2604-V7731	Medutest	2026-Q2	99.19	5.14	—	Supplier-supplied	0	PASS
AX-2026-043141	BPC-157	SSA-2601-N6863	Janoshik	2026-Q2	98.06	4.06	94.6	Buyer-sourced	1	MARGINAL
AX-2026-043154	GHK-Cu	SSA-2604-V7731	PeptideMeter	2026-Q2	97.82	4.82	101.6	Buyer-sourced	0	PASS
AX-2026-043137	BPC-157	SSA-2601-N6863	PeptideMeter	2026-Q2	98.17	4.14	—	Buyer-sourced	1	MARGINAL
AX-2026-043162	GHK-Cu	SSA-2604-V7731	Janoshik	2026-Q2	98.50	4.36	—	Supplier-supplied	0	PASS
AX-2026-043134	BPC-157	SSA-2601-N6863	Medutest	2026-Q2	97.89	4.01	—	Buyer-sourced	1	FAIL