AX-2024-004555

Leuprolide · 5 mg declared · Guangzhou JEEP Biotechnology Co., Ltd. · lot JEEP-2408-K8241

MARGINALIDENTITY CONSISTENT

Report ID: AX-2024-004555
Compound: Leuprolide
Compound class: Hypothalamic and posterior-pituitary hormones
Supplier: JEEP — Guangzhou JEEP Biotechnology Co., Ltd.
Batch / lot: JEEP-2408-K8241
Declared label claim: 5mg
Laboratory: Nordanalyt Laboratories
Assay date: 12 Nov 2024
Submitted: 15 Nov 2024
Quarter: 2024-Q4
Submitter: cjc_maleimide
Sample provenance: Supplier-supplied

Section 1

Results

Measured against the index acceptance specification for the hypothalamic and posterior-pituitary hormones 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, 35 min gradient, 214 nm	99.83	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.17	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — oxidised Trp (+16 Da)	0.12	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1208.6612	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1208.6651	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+3.2	ppm	± 15	PASS
Peptide content	not ordered on this submission	not determined	—	required to check label claim	NOT TESTED
Water content	Karl Fischer, coulometric, duplicate	4.89	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	2.94	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.50	%	—	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	4.80	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 35 min gradient	10.95	min	10.89 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	0.86	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	53,780	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [L-Leu6]-diastereomer	1.08	—	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, 35 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 53,780, and skew follows the reported asymmetry factor of 0.86. 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 0.12 % impurity against a 99.83 % 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	Leuprolide — main peak	10.95	4,852,047	99.83	—
2	oxidised Trp (+16 Da)	10.58	5,832	0.12	+15.995
3	[L-Leu6]-diastereomer	10.74	1,458	0.03	0.000
4	des-ethylamide (+1 Da)	11.23	972	0.02	-27.047
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 1208.6612 Da, computed from C59H84N16O12. 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 1208.6651 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 (%)
3+	403.8943	403.8956	0.0013	7.8
2+	605.3379	605.3398	0.0019	54.9
1+	1209.6685	1209.6724	0.0039	100.0

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)	99.86	99.83	divergence +0.54 pp vs batch median
Total impurities (% area)	-0.62	0.17
Largest single impurity (% area)	-0.32	0.12
Water (%)	not stated	4.89
Counter-ion (%)	not stated	2.94
Peptide content (%w/w)	91.7	not determined
Endotoxin (EU/mg)	0.22	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, 7 d) → assay. Submitter did not handle the vial.
Assay date: 12 Nov 2024
Submitted to the index: 15 Nov 2024
Laboratory: Nordanalyt Laboratories, Uppsala, Sweden
Method basis: 35 min gradient · high-resolution MS
Verification status: IDENTITY CONSISTENT

What this report does not establish

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 4

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.

wide_iqr15 Nov 2024

A single result at 99.83 % is one draw. What makes a supplier's process legible is the spread across its lots, and that is on the scorecard rather than here. This record is one good point in a distribution worth reading whole.

c18_2p615 Nov 2024

Column chemistry flatters or punishes a figure like this. A core-shell column at this gradient resolves the close-eluting family that a fully porous 5 µm bed merges, so 99.83 % here is a harder number than the same figure from a coarser column.

racemisation_ala15 Nov 2024

Epimerisation during activation produces a diastereomer that is mass-identical and only chromatographically separable. At this gradient length the separation exists, and 99.83 % is net of it.

buyer_sourced15 Nov 2024

Provenance and purity together are what make a figure like this usable. An independently purchased vial at 99.83 % is worth several supplier-selected ones.

Section 7

Related records

Same batch — lot JEEP-2408-K8241 n=3

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004556	JEEP-2408-K8241	Janoshik	2024-Q4	99.28	4.72	102.1	Buyer-sourced	2	MARGINAL
AX-2024-004557	JEEP-2408-K8241	Janoshik	2024-Q4	99.32	4.70	—	Buyer-sourced	2	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Leuprolide records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-043347	WXT	WXT-2604-K2596	PeptideMeter	2026-Q3	99.16	5.99	93.6	Buyer-sourced	PASS
AX-2026-043353	WXT	WXT-2604-K2596	Janoshik	2026-Q3	99.19	4.90	95.3	Laboratory-retained	PASS
AX-2026-043345	WXT	WXT-2604-K2596	Janoshik	2026-Q3	98.93	5.28	—	Buyer-sourced	PASS
AX-2026-043346	WXT	WXT-2604-K2596	PeptideMeter	2026-Q3	98.63	5.85	94.7	Laboratory-retained	PASS
AX-2026-043348	WXT	WXT-2604-K2596	Janoshik	2026-Q3	98.70	5.74	99.0	Buyer-sourced	PASS
AX-2026-043354	WXT	WXT-2604-K2596	Janoshik	2026-Q3	99.41	5.44	—	Supplier-supplied	PASS
AX-2026-043355	WXT	WXT-2604-K2596	VendorInvestigate	2026-Q3	98.73	5.94	—	Buyer-sourced	PASS
AX-2026-043352	WXT	WXT-2604-K2596	Janoshik	2026-Q3	99.11	5.51	—	Buyer-sourced	PASS

Other recent JEEP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042177	Hexarelin	JEEP-2608-Y9547	Janoshik	2026-Q3	99.90	3.42	—	Buyer-sourced	0	PASS
AX-2026-042162	Semaglutide	JEEP-2607-X9091	Janoshik	2026-Q3	98.98	3.46	—	Laboratory-retained	1	MARGINAL
AX-2026-042127	TB-500	JEEP-2602-V8614	Medutest	2026-Q3	99.68	3.55	—	Buyer-sourced	1	FAIL
AX-2026-042123	TB-500	JEEP-2602-V8614	PeptideMeter	2026-Q3	99.93	3.80	—	Buyer-sourced	0	PASS
AX-2026-042124	TB-500	JEEP-2602-V8614	PeptideMeter	2026-Q3	99.91	3.37	104.9	Buyer-sourced	0	PASS
AX-2026-042178	Hexarelin	JEEP-2608-Y9547	VendorInvestigate	2026-Q3	99.68	4.03	—	Buyer-sourced	0	PASS
AX-2026-042163	Semaglutide	JEEP-2607-X9091	Nordanalyt	2026-Q3	99.46	4.52	—	Buyer-sourced	1	MARGINAL
AX-2026-042122	TB-500	JEEP-2602-V8614	PeptideMeter	2026-Q3	99.60	3.58	97.0	Buyer-sourced	0	PASS