AX-2025-019025

Pramlintide · 1 mg declared · Asymchem Laboratories (Tianjin) Co., Ltd. · lot ASY-{CAT}-2288

PASSPURITY ONLY

Report ID: AX-2025-019025
Compound: Pramlintide
Compound class: Incretin analogues and co-agonists
Supplier: ASY — Asymchem Laboratories (Tianjin) Co., Ltd.
Batch / lot: ASY-{CAT}-2288
Declared label claim: 1mg
Laboratory: Janoshik Analytical
Assay date: 21 Oct 2025
Submitted: 29 Oct 2025
Quarter: 2025-Q4
Submitter: cjc_maleimide
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, 30 min gradient, 214 nm	99.48	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.52	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — C-terminal free acid (+1 Da)	0.29	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	4.84	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	3.79	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.74	%	—	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	White cake, partial shrinkage from vial wall	—	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	4.47	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	13.93	min	13.94 ± 0.35 (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	31,751	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	0.90	—	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 31,751, 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 0.29 % impurity against a 99.48 % 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	13.93	4,835,036	99.48	—
2	C-terminal free acid (+1 Da)	14.22	14,095	0.29	+0.984
3	open-chain (reduced disulfide, +2 Da)	13.01	5,832	0.12	+2.016
4	des-Lys1 (−128 Da)	13.42	2,916	0.06	-128.095
5	pramlintide dimer	16.87	2,430	0.05	+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 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.

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	99.48	divergence +0.21 pp vs batch median
Total impurities (% area)	0.84	0.52
Largest single impurity (% area)	0.43	0.29
Water (%)	not stated	4.84
Counter-ion (%)	3.0	3.79
Peptide content (%w/w)	92.9	not determined
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 (ambient, 9 d) → laboratory (hand-carried, 6 d) → assay.
Assay date: 21 Oct 2025
Submitted to the index: 29 Oct 2025
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 min gradient · high-resolution MS
Verification status: PURITY ONLY

What this report does not establish

That the compound is the compound named. No identity confirmation was ordered on this submission. A purity figure describes chromatographic homogeneity of whatever eluted; it does not name it.
How much of the named compound is in the vial. Peptide content was not determined, so recovered mass cannot be calculated and the label claim cannot be checked.
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 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.

buyer_sourced29 Oct 2025

Buyer-sourced through an ordinary retail order, so the supplier had no opportunity to select the vial. This is the provenance class the index weights and it is roughly 87 % of the dataset.

quarter_over_quarter29 Oct 2025

A longitudinal set of retail purchases from one supplier across four quarters is the strongest supplier-level evidence available. Several contributors here are building exactly that.

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-2025-019023	ASY-{CAT}-2288	Janoshik	2025-Q4	98.95	4.38	102.5	Buyer-sourced	PASS
AX-2025-019024	ASY-{CAT}-2288	VendorInvestigate	2025-Q4	98.76	4.32	—	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-2025-019023	ASY	ASY-{CAT}-2288	Janoshik	2025-Q4	98.95	4.38	102.5	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