AX-2025-019023 · Pramlintide · ASY lot ASY-{CAT}-2288

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	98.95	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.05	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — C-terminal free acid (+1 Da)	0.58	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	3947.1064	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	3947.1190	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+3.2	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	91.64	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	90.68	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	1.13	mg	1 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	1.025	mg	1 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	102.5	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.38	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.64	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.34	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	3.12	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	5.42	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	13.77	min	13.94 ± 0.35 (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	77,814	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.43	—	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 77,814, 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 0.58 % impurity against a 98.95 % 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	Pramlintide — main peak	13.77	4,809,277	98.95	—
2	C-terminal free acid (+1 Da)	14.06	28,190	0.58	+0.984
3	open-chain (reduced disulfide, +2 Da)	12.85	11,665	0.24	+2.016
4	des-Lys1 (−128 Da)	13.26	5,832	0.12	-128.095
5	pramlintide dimer	16.71	5,346	0.11	+3945.091
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 3947.1064 Da, computed from C171H267N51O53S2. 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 3947.1190 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 (%)
6+	658.8583	658.8604	0.0021	8.0
5+	790.4286	790.4311	0.0025	57.4
4+	987.7839	987.7870	0.0031	100.0
3+	1316.7094	1316.7136	0.0042	49.6
2+	1974.5605	1974.5668	0.0063	8.6

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	4.38
Counter-ion (acetate)	ion chromatography	3.64
Residual solvent + inorganic residue	estimated	0.34
Total peptide content	by difference	91.64
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)	99.16	98.95	divergence +0.21 pp vs batch median
Total impurities (% area)	0.84	1.05
Largest single impurity (% area)	0.43	0.58
Water (%)	not stated	4.38
Counter-ion (%)	3.0	3.64
Peptide content (%w/w)	92.9	91.64
Endotoxin (EU/mg)	not stated	3.12
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, 21 d) → laboratory (courier, dry ice, 3 d) → assay.
Assay date: 08 Dec 2025
Submitted to the index: 21 Dec 2025
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

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 ASY-{CAT}-2288 n=11

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2025-019018	ASY-{CAT}-2288	Janoshik	2025-Q4	99.36	4.49	—	Buyer-sourced	PASS
AX-2025-019019	ASY-{CAT}-2288	PeptideMeter	2025-Q4	98.91	4.18	104.5	Buyer-sourced	PASS
AX-2025-019020	ASY-{CAT}-2288	VendorInvestigate	2025-Q4	99.18	5.11	106.8	Buyer-sourced	PASS
AX-2025-019021	ASY-{CAT}-2288	Nordanalyt	2025-Q4	98.52	5.26	—	Buyer-sourced	PASS
AX-2025-019022	ASY-{CAT}-2288	PeptideMeter	2025-Q4	99.27	5.19	—	Buyer-sourced	PASS
AX-2025-019024	ASY-{CAT}-2288	VendorInvestigate	2025-Q4	98.76	4.32	—	Buyer-sourced	PASS
AX-2025-019025	ASY-{CAT}-2288	Janoshik	2025-Q4	99.48	4.84	—	Buyer-sourced	PASS
AX-2025-019026	ASY-{CAT}-2288	PeptideMeter	2025-Q4	98.93	4.47	—	Buyer-sourced	PASS
AX-2025-019027	ASY-{CAT}-2288	PeptideMeter	2025-Q4	98.89	4.89	—	Buyer-sourced	PASS
AX-2026-041798	ASY-{CAT}-2288	VendorInvestigate	2025-Q4	99.10	4.53	98.7	Laboratory-retained	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Pramlintide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-041478	QSC	QSC-2511-T5459	Janoshik	2026-Q1	98.75	5.31	—	Laboratory-retained	PASS
AX-2026-041480	QSC	QSC-2511-T5459	PeptideMeter	2026-Q1	99.37	5.83	96.0	Buyer-sourced	PASS
AX-2026-041479	QSC	QSC-2511-T5459	PeptideMeter	2026-Q1	99.67	5.11	—	Buyer-sourced	PASS
AX-2026-041481	QSC	QSC-2511-T5459	Kestrel	2026-Q1	99.52	5.29	—	Buyer-sourced	PASS
AX-2026-041798	ASY	ASY-{CAT}-2288	VendorInvestigate	2025-Q4	99.10	4.53	98.7	Laboratory-retained	PASS
AX-2025-019022	ASY	ASY-{CAT}-2288	PeptideMeter	2025-Q4	99.27	5.19	—	Buyer-sourced	PASS
AX-2025-019024	ASY	ASY-{CAT}-2288	VendorInvestigate	2025-Q4	98.76	4.32	—	Buyer-sourced	PASS
AX-2025-019020	ASY	ASY-{CAT}-2288	VendorInvestigate	2025-Q4	99.18	5.11	106.8	Buyer-sourced	PASS

Other recent ASY records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041776	TB-500	ASY-{CAT}-2167	Janoshik	2026-Q3	99.92	4.61	98.2	Buyer-sourced	0	PASS
AX-2026-041777	TB-500	ASY-{CAT}-2167	PeptideMeter	2026-Q3	99.78	4.09	92.8	Buyer-sourced	0	PASS
AX-2026-041786	Retatrutide	ASY-{CAT}-2288	VendorInvestigate	2026-Q3	98.78	6.59	—	Buyer-sourced	0	PASS
AX-2026-041782	TB-500	ASY-{CAT}-2167	Nordanalyt	2026-Q3	99.93	3.94	—	Buyer-sourced	0	PASS
AX-2026-041793	Retatrutide	ASY-{CAT}-2288	Nordanalyt	2026-Q3	98.34	6.16	104.8	Buyer-sourced	0	PASS
AX-2026-041784	Retatrutide	ASY-{CAT}-2288	PeptideMeter	2026-Q3	98.15	6.26	91.9	Buyer-sourced	0	PASS
AX-2026-041774	TB-500	ASY-{CAT}-2167	PeptideMeter	2026-Q3	99.93	4.41	96.2	Buyer-sourced	0	PASS
AX-2026-041780	TB-500	ASY-{CAT}-2167	Janoshik	2026-Q3	99.93	3.48	102.5	Buyer-sourced	1	FAIL