AX-2024-005130

Sermorelin · 15 mg declared · Zhuhai Kerui Biotechnology Co., Ltd. · lot KP-2312-R4578

MARGINALPURITY ONLY

Report ID: AX-2024-005130
Compound: Sermorelin
Compound class: Growth-hormone axis peptides
Supplier: KP — Zhuhai Kerui Biotechnology Co., Ltd.
Batch / lot: KP-2312-R4578
Declared label claim: 15mg
Laboratory: Janoshik Analytical
Assay date: 24 Jun 2024
Submitted: 25 Jun 2024
Quarter: 2024-Q2
Submitter: ja.cabrera
Sample provenance: Supplier-supplied

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	99.57	% area	≥ 98.0	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.43	% area	≤ 2.0	PASS
Largest single impurity	RP-HPLC — des-Tyr1 (−163 Da)	0.15	% 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	86.11	%w/w	—	NOT TESTED
Target-compound content	total peptide content × purity	85.74	%w/w	—	NOT TESTED
Gross fill (as weighed)	five-place balance, under nitrogen	15.59	mg	15 mg declared	NOT TESTED
Recovered target peptide	gross fill × target content	13.367	mg	15 mg claim	NOT TESTED
Recovery against label claim	recovered ÷ claim	89.1	%	90.0 – 110.0	FAIL
Water content	Karl Fischer, coulometric, duplicate	7.31	%	≤ 9.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	5.70	%	≤ 12.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.88	%	—	NOT TESTED
Endotoxin	not ordered on this submission	not determined	—	≤ 5.0	NOT TESTED
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	Faint haze, clearing on standing	—	clear, no visible particulates	FAIL
pH (reconstituted, 1 mg/mL)	potentiometric, two-point calibration	5.95	—	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	0.86	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	62,075	—	≥ 20,000	PASS
Resolution to nearest impurity	vs deamidated Asn8 (+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 62,075, 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 0.15 % impurity against a 99.57 % 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	4,839,411	99.57	—
2	des-Tyr1 (−163 Da)	12.00	7,290	0.15	-163.063
3	aspartimide (−18 Da)	12.88	6,804	0.14	-18.011
4	deamidated Asn8 (+1 Da)	12.22	4,374	0.09	+0.984
5	truncated (1-25)	11.48	2,430	0.05	-455.248
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	7.31
Counter-ion (acetate)	ion chromatography	5.70
Residual solvent + inorganic residue	estimated	0.88
Total peptide content	by difference	86.11
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)	99.06	99.57	divergence -0.19 pp vs batch median
Total impurities (% area)	not stated	0.43
Largest single impurity (% area)	not stated	0.15
Water (%)	5.7	7.31
Counter-ion (%)	not stated	5.70
Peptide content (%w/w)	89.5	86.11
Endotoxin (EU/mg)	not stated	not determined
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, 5 d) → assay. Submitter did not handle the vial.
Assay date: 24 Jun 2024
Submitted to the index: 25 Jun 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 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 KP-2312-R4578 n=10

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2024-005124	KP-2312-R4578	Janoshik	2024-Q2	99.25	6.77	93.7	Supplier-supplied	0	PASS
AX-2024-005125	KP-2312-R4578	Janoshik	2024-Q2	99.50	7.05	—	Supplier-supplied	0	PASS
AX-2024-005126	KP-2312-R4578	Janoshik	2024-Q2	98.80	7.25	100.5	Supplier-supplied	1	MARGINAL
AX-2024-005127	KP-2312-R4578	Medutest	2024-Q2	99.36	7.55	102.2	Supplier-supplied	1	FAIL
AX-2024-005128	KP-2312-R4578	Medutest	2024-Q2	99.10	7.46	96.2	Supplier-supplied	0	PASS
AX-2024-005129	KP-2312-R4578	Nordanalyt	2024-Q2	99.29	6.49	—	Supplier-supplied	0	PASS
AX-2024-005131	KP-2312-R4578	VendorInvestigate	2024-Q2	98.47	6.84	—	Buyer-sourced	0	PASS
AX-2024-005132	KP-2312-R4578	Janoshik	2024-Q2	99.24	7.04	—	Supplier-supplied	0	PASS
AX-2024-005133	KP-2312-R4578	Medutest	2024-Q2	98.28	7.26	—	Laboratory-retained	0	PASS

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-2026-042057	TFC	TFC-2605-Y6440	Janoshik	2026-Q3	98.68	3.94	98.3	Supplier-supplied	0	PASS
AX-2026-043421	WXT	WXT-2608-P4867	Janoshik	2026-Q3	98.15	3.09	—	Supplier-supplied	0	PASS
AX-2026-043420	WXT	WXT-2608-P4867	Medutest	2026-Q3	98.62	3.07	96.4	Supplier-supplied	0	PASS
AX-2026-043423	WXT	WXT-2608-P4867	Janoshik	2026-Q3	98.28	3.86	98.5	Buyer-sourced	0	PASS
AX-2026-042058	TFC	TFC-2605-Y6440	Nordanalyt	2026-Q3	98.71	3.69	107.1	Supplier-supplied	0	PASS
AX-2026-043422	WXT	WXT-2608-P4867	Medutest	2026-Q3	98.35	3.59	—	Supplier-supplied	1	MARGINAL
AX-2026-043418	WXT	WXT-2608-P4867	Janoshik	2026-Q3	98.47	2.88	89.7	Supplier-supplied	1	MARGINAL
AX-2026-042060	TFC	TFC-2605-Y6440	Nordanalyt	2026-Q3	98.31	3.30	92.4	Supplier-supplied	0	PASS

Other recent KP records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-043029	Retatrutide	KP-2607-H5219	Medutest	2026-Q3	95.45	5.71	—	Supplier-supplied	2	FAIL
AX-2026-043030	Retatrutide	KP-2607-H5219	Kestrel	2026-Q3	95.97	6.95	97.1	Supplier-supplied	2	FAIL
AX-2026-043106	Tirzepatide	KP-2608-D5921	PeptideMeter	2026-Q3	98.90	5.45	105.4	Supplier-supplied	2	MARGINAL
AX-2026-043108	Tirzepatide	KP-2608-D5921	Janoshik	2026-Q3	99.70	5.45	—	Supplier-supplied	2	MARGINAL
AX-2026-043039	Retatrutide	KP-2607-H5219	Janoshik	2026-Q3	96.14	5.62	—	Supplier-supplied	2	FAIL
AX-2026-043100	Tirzepatide	KP-2608-D5921	VendorInvestigate	2026-Q3	98.27	5.31	94.4	Buyer-sourced	2	MARGINAL
AX-2026-043090	Ipamorelin	KP-2606-D5887	Janoshik	2026-Q3	98.18	3.07	101.2	Laboratory-retained	1	FAIL
AX-2026-043028	Retatrutide	KP-2607-H5219	Janoshik	2026-Q3	96.52	6.09	—	Supplier-supplied	2	MARGINAL