AX-2024-004490

Tirzepatide · 30 mg declared · Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. · lot FGP-2408-H1549

MARGINALVERIFIED

Report ID: AX-2024-004490
Compound: Tirzepatide
Compound class: Incretin analogues and co-agonists
Supplier: FGP — Flourishglobal Peptide Biotech (Chengdu) Co., Ltd.
Batch / lot: FGP-2408-H1549
Declared label claim: 30mg
Laboratory: Janoshik Analytical
Assay date: 12 Oct 2024
Submitted: 30 Oct 2024
Quarter: 2024-Q4
Submitter: n.fontaine
Sample provenance: Supplier-supplied

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	99.08	% area	≥ 97.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.92	% area	≤ 3.0	PASS
Largest single impurity	RP-HPLC — Met(O) sulfoxide (+16 Da)	0.57	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	4810.4103	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	4810.4223	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+2.5	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	84.92	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	84.14	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	36.29	mg	30 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	30.534	mg	30 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	101.8	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	7.34	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	6.85	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.89	%	—	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	Off-white lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Visible particulates, did not clear	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.13	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	19.74	min	19.86 ± 0.45 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.33	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	46,176	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib13]-diastereomer	0.50	—	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 46,176, and skew follows the reported asymmetry factor of 1.33. 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 0.57 % impurity against a 99.08 % 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	Tirzepatide — main peak	19.74	4,815,595	99.08	—
2	Met(O) sulfoxide (+16 Da)	19.00	27,704	0.57	+15.995
3	C20 diacid mono-amide	21.36	7,776	0.16	+0.984
4	trifluoroacetyl adduct (+96 Da)	20.67	5,346	0.11	+95.982
5	[D-Aib13]-diastereomer	19.55	1,944	0.04	0.000
6	des-Aib2 analogue	19.39	1,944	0.04	-85.053
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 4810.4103 Da, computed from C225H348N48O68. 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 4810.4223 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+	688.2087	688.2105	0.0018	8.5
6+	802.7423	802.7443	0.0020	57.4
5+	963.0893	963.0917	0.0024	100.0
4+	1203.6099	1203.6129	0.0030	49.7
3+	1604.4774	1604.4814	0.0040	8.4

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	7.34
Counter-ion (TFA)	ion chromatography	6.85
Residual solvent + inorganic residue	estimated	0.89
Total peptide content	by difference	84.92
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)	99.72	99.08	divergence +0.03 pp vs batch median
Total impurities (% area)	not stated	0.92
Largest single impurity (% area)	not stated	0.57
Water (%)	6.6	7.34
Counter-ion (%)	not stated	6.85
Peptide content (%w/w)	not stated	84.92
Endotoxin (EU/mg)	0.23	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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 8 d) → assay. Submitter did not handle the vial.
Assay date: 12 Oct 2024
Submitted to the index: 30 Oct 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 free of bacterial endotoxin. Endotoxin was not measured. No chromatographic result bears on it.
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

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 FGP-2408-H1549 n=6

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004485	FGP-2408-H1549	PeptideMeter	2024-Q4	99.93	6.72	100.6	Supplier-supplied	1	MARGINAL
AX-2024-004486	FGP-2408-H1549	Nordanalyt	2024-Q4	99.93	7.37	—	Supplier-supplied	0	PASS
AX-2024-004487	FGP-2408-H1549	Janoshik	2024-Q4	99.75	6.93	96.6	Supplier-supplied	1	MARGINAL
AX-2024-004488	FGP-2408-H1549	Janoshik	2024-Q4	99.14	7.74	—	Supplier-supplied	1	MARGINAL
AX-2024-004489	FGP-2408-H1549	Kestrel	2024-Q4	99.62	6.87	95.5	Supplier-supplied	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Tirzepatide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043106	KP	KP-2608-D5921	PeptideMeter	2026-Q3	98.90	5.45	105.4	Supplier-supplied	2	MARGINAL
AX-2026-041742	FGP	FGP-2603-L9714	Janoshik	2026-Q3	99.37	2.43	105.5	Supplier-supplied	1	MARGINAL
AX-2026-043108	KP	KP-2608-D5921	Janoshik	2026-Q3	99.70	5.45	—	Supplier-supplied	2	MARGINAL
AX-2026-041741	FGP	FGP-2603-L9714	PeptideMeter	2026-Q3	98.62	2.57	—	Supplier-supplied	1	MARGINAL
AX-2026-043100	KP	KP-2608-D5921	VendorInvestigate	2026-Q3	98.27	5.31	94.4	Buyer-sourced	2	MARGINAL
AX-2026-043322	CPC	CPC-2607-L2552	Janoshik	2026-Q3	96.79	4.88	96.1	Supplier-supplied	2	FAIL
AX-2026-043111	KP	KP-2608-D5921	PeptideMeter	2026-Q3	99.71	5.15	—	Supplier-supplied	2	MARGINAL
AX-2026-043321	CPC	CPC-2607-L2552	Kestrel	2026-Q3	97.84	5.34	—	Supplier-supplied	2	MARGINAL

Other recent FGP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041742	Tirzepatide	FGP-2603-L9714	Janoshik	2026-Q3	99.37	2.43	105.5	Supplier-supplied	1	MARGINAL
AX-2026-041767	Semaglutide	FGP-2602-M1508	PeptideMeter	2026-Q3	98.65	2.54	—	Supplier-supplied	2	FAIL
AX-2026-041741	Tirzepatide	FGP-2603-L9714	PeptideMeter	2026-Q3	98.62	2.57	—	Supplier-supplied	1	MARGINAL
AX-2026-041772	Semaglutide	FGP-2602-M1508	Janoshik	2026-Q3	99.79	3.03	107.5	Supplier-supplied	0	PASS
AX-2026-041770	Semaglutide	FGP-2602-M1508	VendorInvestigate	2026-Q3	99.33	1.48	90.3	Buyer-sourced	1	MARGINAL
AX-2026-041769	Semaglutide	FGP-2602-M1508	Janoshik	2026-Q3	99.13	2.55	92.9	Supplier-supplied	1	MARGINAL
AX-2026-041768	Semaglutide	FGP-2602-M1508	Janoshik	2026-Q3	98.85	2.20	90.3	Supplier-supplied	1	MARGINAL
AX-2026-041771	Semaglutide	FGP-2602-M1508	Janoshik	2026-Q3	99.41	2.31	—	Supplier-supplied	0	PASS