AX-2024-004365

Sermorelin · 5 mg declared · Flourishglobal Peptide Biotech (Chengdu) Co., Ltd. · lot FGP-2406-D8645

MARGINALPURITY ONLY

Report ID: AX-2024-004365
Compound: Sermorelin
Compound class: Growth-hormone axis peptides
Supplier: FGP — Flourishglobal Peptide Biotech (Chengdu) Co., Ltd.
Batch / lot: FGP-2406-D8645
Declared label claim: 5mg
Laboratory: Janoshik Analytical
Assay date: 16 Sep 2024
Submitted: 25 Sep 2024
Quarter: 2024-Q3
Submitter: i.zielinski
Sample provenance: Buyer-sourced

Section 1

Results

Measured against the index acceptance specification for the growth-hormone axis peptides 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	99.59	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.41	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — des-Tyr1 (−163 Da)	0.19	% 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	92.13	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	91.75	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	5.34	mg	5 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	4.899	mg	5 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	98.0	%	90.0 – 110.0	PASS
Water content	Karl Fischer, coulometric, duplicate	3.04	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.05	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.78	%	—	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	Off-white lyophilised cake, intact	—	white to off-white intact cake	PASS
Reconstitution clarity	reconstituted per submitter procedure	Clear after 90 s gentle swirling, no particulates	—	clear, no visible particulates	PASS
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	4.92	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	12.52	min	12.42 ± 0.30 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.29	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	48,501	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated Asn8 (+1 Da)	1.29	—	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 48,501, and skew follows the reported asymmetry factor of 1.29. 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 0.19 % impurity against a 99.59 % 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	Sermorelin — main peak	12.52	4,840,383	99.59	—
2	des-Tyr1 (−163 Da)	12.00	9,235	0.19	-163.063
3	truncated (1-25)	11.48	4,860	0.10	-455.248
4	aspartimide (−18 Da)	12.88	2,916	0.06	-18.011
5	deamidated Asn8 (+1 Da)	12.22	2,916	0.06	+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.

Component	Determination	%w/w of cake
Water	Karl Fischer	3.04
Counter-ion (acetate)	ion chromatography	4.05
Residual solvent + inorganic residue	estimated	0.78
Total peptide content	by difference	92.13
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)	99.43	99.59	divergence -0.01 pp vs batch median
Total impurities (% area)	1.27	0.41
Largest single impurity (% area)	0.79	0.19
Water (%)	not stated	3.04
Counter-ion (%)	not stated	4.05
Peptide content (%w/w)	not stated	92.13
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, 14 d) → laboratory (hand-carried, 12 d) → assay.
Assay date: 16 Sep 2024
Submitted to the index: 25 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.
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 3

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.

ms_confirm25 Sep 2024

Purity at 99.59 % with identity confirmed on the same submission is the combination worth having. Either alone leaves a question the other answers.

coa_template25 Sep 2024

The document that arrived with this order is on file and its fields are scored on the supplier's documentation rubric. That score describes what a buyer receives, which is the useful version.

valley_drop25 Sep 2024

des-Tyr1 (−163 Da) at 0.19 % elutes close enough to the main peak that drop-line and valley-to-valley will not agree. The index prints the resolution figure and applies no criterion to it — how close the nearest impurity sits is a property of the compound and the gradient, not of the system. What matters is that the convention used is stated.

Section 7

Related records

Same batch — lot FGP-2406-D8645 n=3

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-004366	FGP-2406-D8645	Janoshik	2024-Q3	99.44	2.56	107.1	Buyer-sourced	1	MARGINAL
AX-2024-004367	FGP-2406-D8645	Janoshik	2024-Q3	99.37	3.47	103.2	Buyer-sourced	1	MARGINAL

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Sermorelin records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042339	TFC	TFC-2605-Y2176	Kestrel	2026-Q3	99.93	4.14	—	Supplier-supplied	1	FAIL
AX-2026-043389	WXT	WXT-2608-P3387	Medutest	2026-Q3	98.97	3.44	99.6	Supplier-supplied	0	PASS
AX-2026-042338	TFC	TFC-2605-Y2176	Janoshik	2026-Q3	98.96	3.27	—	Supplier-supplied	0	PASS
AX-2026-042341	TFC	TFC-2605-Y2176	Janoshik	2026-Q3	98.55	3.45	—	Buyer-sourced	0	PASS
AX-2026-042340	TFC	TFC-2605-Y2176	Medutest	2026-Q3	99.34	3.73	106.9	Buyer-sourced	0	PASS
AX-2026-041954	AMB	AMB-2512-V5420	Medutest	2026-Q2	99.07	3.72	—	Buyer-sourced	0	PASS
AX-2026-041958	AMB	AMB-2512-V5420	Janoshik	2026-Q2	99.14	4.48	—	Buyer-sourced	1	FAIL
AX-2026-041955	AMB	AMB-2512-V5420	Janoshik	2026-Q2	99.10	3.17	—	Buyer-sourced	0	PASS

Other recent FGP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Result
AX-2026-041643	Semaglutide	FGP-2602-M8547	Janoshik	2026-Q3	99.31	2.79	100.7	Buyer-sourced	PASS
AX-2026-041638	Semaglutide	FGP-2602-M8547	Janoshik	2026-Q3	99.40	2.75	105.8	Buyer-sourced	PASS
AX-2026-041641	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	98.98	2.38	105.0	Buyer-sourced	PASS
AX-2026-041610	Tirzepatide	FGP-2603-L7753	Janoshik	2026-Q3	98.81	2.45	101.0	Buyer-sourced	PASS
AX-2026-041637	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	99.40	2.83	—	Laboratory-retained	PASS
AX-2026-041642	Semaglutide	FGP-2602-M8547	PeptideMeter	2026-Q3	98.78	2.24	—	Buyer-sourced	PASS
AX-2026-041609	Tirzepatide	FGP-2603-L7753	Janoshik	2026-Q3	98.52	2.00	98.0	Buyer-sourced	PASS
AX-2026-041636	Semaglutide	FGP-2602-M8547	Nordanalyt	2026-Q3	99.39	2.17	—	Buyer-sourced	PASS