AX-2024-005100 · Pramlintide · MKM lot MKM-2405-U4415

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, 15 min gradient, 214 nm	99.55	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.45	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — open-chain (reduced disulfide, +2 Da)	0.27	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	3947.1064	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, unit resolution (single quadrupole)	3947.1088	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+0.6	ppm	± 15	PASS
Total peptide content	by difference from the gravimetric mass balance	87.79	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	87.39	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.36	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.684	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	93.7	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	4.94	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.29	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.98	%	—	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 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	5.09	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 15 min gradient	7.77	min	7.53 ± 0.35 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.12	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	61,823	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.13	—	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, 15 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 61,823, and skew follows the reported asymmetry factor of 1.12. 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 0.27 % impurity against a 99.55 % 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	7.77	4,838,439	99.55	—
2	open-chain (reduced disulfide, +2 Da)	7.31	13,123	0.27	+2.016
3	C-terminal free acid (+1 Da)	7.91	4,374	0.09	+0.984
4	des-Lys1 (−128 Da)	7.51	2,430	0.05	-128.095
5	pramlintide dimer	9.24	1,944	0.04	+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, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 3947.1088 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	658.8587	0.0004	9.1
5+	790.4286	790.4290	0.0004	59.3
4+	987.7839	987.7845	0.0006	100.0
3+	1316.7094	1316.7102	0.0008	61.0
2+	1974.5605	1974.5617	0.0012	8.2

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	4.94
Counter-ion (acetate)	ion chromatography	6.29
Residual solvent + inorganic residue	estimated	0.98
Total peptide content	by difference	87.79
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)	99.83	99.55	divergence +0.93 pp vs batch median
Total impurities (% area)	0.17	0.45
Largest single impurity (% area)	not stated	0.27
Water (%)	3.2	4.94
Counter-ion (%)	2.5	6.29
Peptide content (%w/w)	93.7	87.79
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: Laboratory-retained
Evidentiary weight: Provenance documented, selection uncontrolled.
Chain of custody: Laboratory retained sample (−20 °C, 19 d since original receipt) → re-assay.
Assay date: 02 Aug 2024
Submitted to the index: 18 Aug 2024
Laboratory: Kestrel Bioanalytical, Melbourne, Australia
Method basis: 15 min gradient · unit-resolution MS
Verification status: METHOD LIMITED

What this report does not establish

That the compound is not a near-isobaric alternative. Identity was confirmed at unit mass resolution, which cannot exclude species differing by 1 or 2 Da. The specific alternatives not excluded are named in the identity block above.
That mass-identical impurities are absent. The gradient used is shorter than the index reference method and does not resolve the diastereomers named in the compound fingerprint. The purity figure is an upper bound.
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 MKM-2405-U4415 n=11

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005095	MKM-2405-U4415	Kestrel	2024-Q3	99.36	3.75	97.2	Supplier-supplied	0	PASS
AX-2024-005096	MKM-2405-U4415	Janoshik	2024-Q3	98.73	4.24	97.2	Buyer-sourced	0	PASS
AX-2024-005097	MKM-2405-U4415	Janoshik	2024-Q3	99.03	4.15	98.4	Supplier-supplied	0	PASS
AX-2024-005098	MKM-2405-U4415	PeptideMeter	2024-Q3	98.79	4.20	94.5	Supplier-supplied	0	PASS
AX-2024-005099	MKM-2405-U4415	Janoshik	2024-Q3	98.57	4.31	96.3	Supplier-supplied	0	PASS
AX-2024-005101	MKM-2405-U4415	Janoshik	2024-Q3	99.19	4.63	—	Supplier-supplied	0	PASS
AX-2024-005102	MKM-2405-U4415	Janoshik	2024-Q3	98.50	4.16	93.5	Buyer-sourced	1	MARGINAL
AX-2024-005103	MKM-2405-U4415	PeptideMeter	2024-Q3	98.24	4.35	93.5	Buyer-sourced	0	PASS
AX-2024-005104	MKM-2405-U4415	Janoshik	2024-Q3	99.57	4.69	90.8	Supplier-supplied	0	PASS
AX-2024-005105	MKM-2405-U4415	Janoshik	2024-Q3	98.90	4.33	93.8	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 MKM records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042943	Adipotide	MKM-2606-K4013	Janoshik	2026-Q3	97.92	6.31	—	Supplier-supplied	1	MARGINAL
AX-2026-042891	CJC-1295 (no DAC)	MKM-2603-V2347	Janoshik	2026-Q3	99.28	3.63	—	Supplier-supplied	1	MARGINAL
AX-2026-042942	Adipotide	MKM-2606-K4013	VendorInvestigate	2026-Q3	97.04	5.56	94.6	Buyer-sourced	1	FAIL
AX-2026-042914	Gonadorelin	MKM-2604-A2596	Janoshik	2026-Q2	99.93	5.19	—	Supplier-supplied	0	PASS
AX-2026-042884	BPC-157	MKM-2605-X2575	Nordanalyt	2026-Q2	98.12	2.89	—	Laboratory-retained	1	MARGINAL
AX-2026-042946	Tirzepatide	MKM-2601-L3752	Medutest	2026-Q2	97.71	8.10	—	Supplier-supplied	1	FAIL
AX-2026-042911	Gonadorelin	MKM-2604-A2596	Medutest	2026-Q2	99.08	5.55	—	Buyer-sourced	1	MARGINAL
AX-2026-042932	L-Glutathione (reduced)	MKM-2511-F2902	Janoshik	2026-Q2	98.57	8.41	92.9	Supplier-supplied	1	MARGINAL