AX-2024-004711

Pramlintide · 1 mg declared · Tianjin Finder Chemical Co., Ltd. · lot TFC-2403-Y7884

PASSPURITY ONLY

Report ID: AX-2024-004711
Compound: Pramlintide
Compound class: Incretin analogues and co-agonists
Supplier: TFC — Tianjin Finder Chemical Co., Ltd.
Batch / lot: TFC-2403-Y7884
Declared label claim: 1mg
Laboratory: Janoshik Analytical
Assay date: 15 Sep 2024
Submitted: 05 Oct 2024
Quarter: 2024-Q3
Submitter: so.okonkwo
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	98.71	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	1.29	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — C-terminal free acid (+1 Da)	0.76	% area	≤ 1.00	PASS
Identity	not ordered on this submission	not determined	—	required for VERIFIED status	NOT TESTED
Total peptide content	by difference from the gravimetric mass balance	89.79	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	88.63	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	1.12	mg	1 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	0.993	mg	1 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	99.3	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	5.04	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.82	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.35	%	—	NOT TESTED
Endotoxin	kinetic chromogenic LAL	0.44	EU/mg	≤ 5.0	PASS
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	5.40	—	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	1.25	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	81,200	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.46	—	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 81,200, and skew follows the reported asymmetry factor of 1.25. 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 0.76 % impurity against a 98.71 % 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	4,797,612	98.71	—
2	C-terminal free acid (+1 Da)	14.06	36,938	0.76	+0.984
3	open-chain (reduced disulfide, +2 Da)	12.85	12,637	0.26	+2.016
4	pramlintide dimer	16.71	6,804	0.14	+3945.091
5	des-Lys1 (−128 Da)	13.26	6,318	0.13	-128.095
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.

Component	Determination	%w/w of cake
Water	Karl Fischer	5.04
Counter-ion (acetate)	ion chromatography	4.82
Residual solvent + inorganic residue	estimated	0.35
Total peptide content	by difference	89.79
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)	99.26	98.71	divergence +0.64 pp vs batch median
Total impurities (% area)	0.74	1.29
Largest single impurity (% area)	0.47	0.76
Water (%)	not stated	5.04
Counter-ion (%)	3.9	4.82
Peptide content (%w/w)	92.0	89.79
Endotoxin (EU/mg)	0.34	0.44
Method stated on certificate	NO	—	no method section — the result cannot be reconciled against any other

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, 2 d) → assay. Submitter did not handle the vial.
Assay date: 15 Sep 2024
Submitted to the index: 05 Oct 2024
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.
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-2403-Y7884 n=10

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004708	TFC-2403-Y7884	Janoshik	2024-Q3	98.72	5.82	—	Supplier-supplied	0	PASS
AX-2024-004709	TFC-2403-Y7884	VendorInvestigate	2024-Q3	97.93	5.79	90.8	Buyer-sourced	2	FAIL
AX-2024-004710	TFC-2403-Y7884	Nordanalyt	2024-Q3	98.99	4.91	—	Supplier-supplied	0	PASS
AX-2024-004712	TFC-2403-Y7884	Janoshik	2024-Q3	99.04	4.98	95.8	Supplier-supplied	0	PASS
AX-2024-004713	TFC-2403-Y7884	PeptideMeter	2024-Q3	98.44	4.78	96.9	Supplier-supplied	0	PASS
AX-2024-004714	TFC-2403-Y7884	Janoshik	2024-Q3	98.40	5.25	102.3	Supplier-supplied	0	PASS
AX-2024-004715	TFC-2403-Y7884	Nordanalyt	2024-Q3	98.36	5.19	95.3	Supplier-supplied	0	PASS
AX-2024-004716	TFC-2403-Y7884	Janoshik	2024-Q3	98.52	5.50	—	Supplier-supplied	0	PASS
AX-2024-004717	TFC-2403-Y7884	Janoshik	2024-Q3	98.84	5.14	94.9	Supplier-supplied	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Pramlintide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043488	WXT	WXT-2603-D6052	Janoshik	2026-Q3	97.87	4.37	—	Supplier-supplied	1	MARGINAL
AX-2026-041569	QSC	QSC-2511-T6680	VendorInvestigate	2026-Q1	98.79	5.63	94.4	Buyer-sourced	2	MARGINAL
AX-2026-041568	QSC	QSC-2511-T6680	Janoshik	2026-Q1	99.16	5.45	—	Supplier-supplied	0	PASS
AX-2026-041563	QSC	QSC-2511-T6680	PeptideMeter	2026-Q1	99.10	6.10	94.2	Supplier-supplied	0	PASS
AX-2026-041572	QSC	QSC-2511-T6680	Janoshik	2026-Q1	99.37	5.63	—	Supplier-supplied	0	PASS
AX-2026-041567	QSC	QSC-2511-T6680	Janoshik	2026-Q1	98.73	5.07	—	Supplier-supplied	1	MARGINAL
AX-2026-041566	QSC	QSC-2511-T6680	PeptideMeter	2026-Q1	99.93	5.27	106.7	Supplier-supplied	1	MARGINAL
AX-2026-041571	QSC	QSC-2511-T6680	PeptideMeter	2026-Q1	99.51	5.25	96.7	Supplier-supplied	0	PASS

Other recent TFC records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041932	Semaglutide	TFC-2604-X4301	Janoshik	2026-Q3	98.88	4.31	—	Supplier-supplied	0	PASS
AX-2026-042067	SS-31 (Elamipretide)	TFC-2604-Y7472	Kestrel	2026-Q3	98.66	4.44	—	Supplier-supplied	1	MARGINAL
AX-2026-042057	Sermorelin	TFC-2605-Y6440	Janoshik	2026-Q3	98.68	3.94	98.3	Supplier-supplied	0	PASS
AX-2026-041936	Semaglutide	TFC-2604-X4301	PeptideMeter	2026-Q3	98.62	4.30	—	Buyer-sourced	1	MARGINAL
AX-2026-041973	Humanin (HNG)	TFC-2605-U5564	Janoshik	2026-Q3	99.62	7.03	—	Supplier-supplied	2	FAIL
AX-2026-041980	Humanin (HNG)	TFC-2605-U5564	Janoshik	2026-Q3	99.90	7.01	88.6	Supplier-supplied	2	MARGINAL
AX-2026-041961	Tirzepatide	TFC-2605-G5134	Medutest	2026-Q3	98.25	7.11	—	Supplier-supplied	2	MARGINAL
AX-2026-042068	SS-31 (Elamipretide)	TFC-2604-Y7472	Medutest	2026-Q3	98.71	3.63	92.9	Supplier-supplied	2	MARGINAL