AX-2024-004655 · Retatrutide · TFC lot TFC-2309-H2397

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, 32 min gradient, 214 nm	98.43	% area	≥ 96.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.57	% area	≤ 3.5	PASS
Largest single impurity	RP-HPLC — [D-Aib2]-diastereomer	0.70	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	4728.4871	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	4728.4895	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+0.5	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	89.51	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.10	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	15.96	mg	15 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	14.061	mg	15 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	93.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.64	%	≤ 8.0	PASS
Counter-ion (TFA)	anion-exchange ion chromatography	6.15	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.70	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	2.51	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 cake, partially collapsed	—	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	2.86	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 32 min gradient	21.99	min	21.98 ± 0.50 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.21	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	51,704	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [D-Aib2]-diastereomer	0.59	—	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, 32 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 51,704, and skew follows the reported asymmetry factor of 1.21. 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 0.70 % impurity against a 98.43 % 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	Retatrutide — main peak	21.99	4,784,003	98.43	—
2	[D-Aib2]-diastereomer	21.76	34,022	0.70	0.000
3	truncated (5-39)	19.94	22,357	0.46	-428.201
4	des-Aib20 analogue	21.52	10,207	0.21	-85.053
5	retatrutide dimer	26.38	5,346	0.11	+4728.487
6	oxidised Trp (+16 Da)	21.29	2,916	0.06	+15.995
7	C18 diacid regioisomer	22.61	1,458	0.03	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 4728.4871 Da, computed from C221H342N46O68. 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 4728.4895 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+	676.5054	676.5058	0.0004	9.0
6+	789.0885	789.0889	0.0004	56.7
5+	946.7047	946.7052	0.0005	100.0
4+	1183.1291	1183.1297	0.0006	56.3
3+	1577.1696	1577.1704	0.0008	9.1

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	3.64
Counter-ion (TFA)	ion chromatography	6.15
Residual solvent + inorganic residue	estimated	0.70
Total peptide content	by difference	89.51
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)	99.90	98.43	divergence +1.27 pp vs batch median
Total impurities (% area)	0.10	1.57
Largest single impurity (% area)	0.07	0.70
Water (%)	2.4	3.64
Counter-ion (%)	2.6	6.15
Peptide content (%w/w)	94.4	89.51
Endotoxin (EU/mg)	not stated	2.51
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 (ambient, 9 d) → laboratory (hand-carried, 11 d) → assay.
Assay date: 21 Jan 2024
Submitted to the index: 02 Feb 2024
Laboratory: VendorInvestigate, Riga, Latvia
Method basis: 32 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

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 TFC-2309-H2397 n=17

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004645	TFC-2309-H2397	Janoshik	2024-Q1	98.53	3.70	90.7	Buyer-sourced	0	PASS
AX-2024-004646	TFC-2309-H2397	Nordanalyt	2024-Q1	98.67	4.32	102.6	Buyer-sourced	2	FAIL
AX-2024-004647	TFC-2309-H2397	Nordanalyt	2024-Q1	98.50	4.42	—	Supplier-supplied	0	PASS
AX-2024-004648	TFC-2309-H2397	PeptideMeter	2024-Q1	98.66	4.06	104.9	Buyer-sourced	0	PASS
AX-2024-004649	TFC-2309-H2397	PeptideMeter	2024-Q1	98.79	3.64	—	Buyer-sourced	0	PASS
AX-2024-004650	TFC-2309-H2397	Medutest	2024-Q1	98.74	3.93	100.4	Buyer-sourced	1	MARGINAL
AX-2024-004651	TFC-2309-H2397	Janoshik	2024-Q1	98.86	3.90	99.4	Buyer-sourced	0	PASS
AX-2024-004652	TFC-2309-H2397	PeptideMeter	2024-Q1	98.63	4.14	—	Buyer-sourced	0	PASS
AX-2024-004653	TFC-2309-H2397	Medutest	2024-Q1	98.29	3.41	—	Laboratory-retained	0	PASS
AX-2024-004654	TFC-2309-H2397	Janoshik	2024-Q1	98.48	4.64	100.7	Buyer-sourced	0	PASS
AX-2024-004656	TFC-2309-H2397	Janoshik	2024-Q1	98.49	4.83	—	Buyer-sourced	1	FAIL
AX-2024-004657	TFC-2309-H2397	PeptideMeter	2024-Q1	98.67	4.27	—	Buyer-sourced	0	PASS
AX-2024-004658	TFC-2309-H2397	PeptideMeter	2024-Q1	98.70	4.31	105.7	Buyer-sourced	0	PASS
AX-2024-004659	TFC-2309-H2397	Medutest	2024-Q1	98.36	3.87	—	Buyer-sourced	0	PASS
AX-2024-004660	TFC-2309-H2397	Medutest	2024-Q1	98.76	3.96	105.4	Buyer-sourced	0	PASS
AX-2024-004661	TFC-2309-H2397	VendorInvestigate	2024-Q1	98.50	4.34	96.3	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Retatrutide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-042437	Homopeptide	HOMO-2605-V4718	Nordanalyt	2026-Q3	98.68	3.67	102.8	Buyer-sourced	PASS
AX-2026-043095	KP	KP-2607-H5774	Janoshik	2026-Q3	95.81	5.48	105.2	Buyer-sourced	FAIL
AX-2026-042282	TFC	TFC-2608-J1156	Janoshik	2026-Q3	98.54	4.27	—	Buyer-sourced	PASS
AX-2026-043094	KP	KP-2607-H5774	PeptideMeter	2026-Q3	96.32	6.40	—	Buyer-sourced	FAIL
AX-2026-042441	Homopeptide	HOMO-2605-V4718	Medutest	2026-Q3	98.93	4.22	—	Buyer-sourced	PASS
AX-2026-041427	QYB	QYB-2604-B4920	PeptideMeter	2026-Q3	97.93	2.45	101.7	Buyer-sourced	PASS
AX-2026-041786	ASY	ASY-{CAT}-2288	VendorInvestigate	2026-Q3	98.78	6.59	—	Buyer-sourced	PASS
AX-2026-041428	QYB	QYB-2604-B4920	Janoshik	2026-Q3	98.35	3.20	—	Laboratory-retained	PASS

Other recent TFC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042265	Humanin (HNG)	TFC-2605-U1300	PeptideMeter	2026-Q3	99.52	6.31	—	Buyer-sourced	0	PASS
AX-2026-042222	SS-31 (Elamipretide)	TFC-2607-R9099	VendorInvestigate	2026-Q3	99.46	5.41	102.6	Buyer-sourced	0	PASS
AX-2026-042236	Humanin (HNG)	TFC-2608-S9940	Nordanalyt	2026-Q3	98.64	1.80	—	Buyer-sourced	0	PASS
AX-2026-042282	Retatrutide	TFC-2608-J1156	Janoshik	2026-Q3	98.54	4.27	—	Buyer-sourced	0	PASS
AX-2026-042226	SS-31 (Elamipretide)	TFC-2607-R9099	Janoshik	2026-Q3	99.62	5.47	—	Buyer-sourced	0	PASS
AX-2026-042217	Semaglutide	TFC-2604-X9037	PeptideMeter	2026-Q3	98.95	4.61	96.9	Buyer-sourced	0	PASS
AX-2026-042339	Sermorelin	TFC-2605-Y2176	Kestrel	2026-Q3	99.93	4.14	—	Supplier-supplied	1	FAIL
AX-2026-042214	Semaglutide	TFC-2604-X9037	Kestrel	2026-Q3	99.87	4.66	103.1	Laboratory-retained	0	PASS