AX-2024-005101

Pramlintide · 5 mg declared · Xi'an Mokemei Biotechnology Co., Ltd. · lot MKM-2405-U4415

PASSPURITY ONLY

Report ID: AX-2024-005101
Compound: Pramlintide
Compound class: Incretin analogues and co-agonists
Supplier: MKM — Xi'an Mokemei Biotechnology Co., Ltd.
Batch / lot: MKM-2405-U4415
Declared label claim: 5mg
Laboratory: Janoshik Analytical
Assay date: 13 Sep 2024
Submitted: 17 Sep 2024
Quarter: 2024-Q3
Submitter: ah.novak
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	99.19	% area	≥ 97.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.81	% area	≤ 2.5	PASS
Largest single impurity	RP-HPLC — open-chain (reduced disulfide, +2 Da)	0.32	% 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	4.63	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	6.33	%	≤ 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	4.43	—	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	1.46	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	75,340	—	≥ 20,000	PASS
Resolution to nearest impurity	vs C-terminal free acid (+1 Da)	1.39	—	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 75,340, and skew follows the reported asymmetry factor of 1.46. 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 0.32 % impurity against a 99.19 % 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	4,820,941	99.19	—
2	open-chain (reduced disulfide, +2 Da)	13.01	15,553	0.32	+2.016
3	des-Lys1 (−128 Da)	13.42	14,581	0.30	-128.095
4	pramlintide dimer	16.87	4,860	0.10	+3945.091
5	C-terminal free acid (+1 Da)	14.22	4,374	0.09	+0.984
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)	99.83	99.19	divergence +0.93 pp vs batch median
Total impurities (% area)	0.17	0.81
Largest single impurity (% area)	not stated	0.32
Water (%)	3.2	4.63
Counter-ion (%)	2.5	6.33
Peptide content (%w/w)	93.7	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: Supplier-supplied
Evidentiary weight: Weaker evidence. Read with the caveat below.
Chain of custody: Supplier despatch → laboratory direct (courier, cold pack, 8 d) → assay. Submitter did not handle the vial.
Assay date: 13 Sep 2024
Submitted to the index: 17 Sep 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.
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

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-2024-005100	MKM-2405-U4415	Kestrel	2024-Q3	99.55	4.94	93.7	Laboratory-retained	1	MARGINAL
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