AX-2026-042069

Triptorelin · 5 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · lot HYB-2512-B7307

PASSIDENTITY CONSISTENT

Report ID: AX-2026-042069
Compound: Triptorelin
Compound class: Hypothalamic and posterior-pituitary hormones
Supplier: HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Batch / lot: HYB-2512-B7307
Declared label claim: 5mg
Laboratory: Janoshik Analytical
Assay date: 17 Feb 2026
Submitted: 28 Feb 2026
Quarter: 2026-Q1
Submitter: b.vogel
Sample provenance: Buyer-sourced

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, 30 min gradient, 214 nm	99.33	% area	≥ 98.5	PASS
Total impurities	RP-HPLC, sum of reported peaks	0.67	% area	≤ 1.5	PASS
Largest single impurity	RP-HPLC — oxidised Trp (+16 Da)	0.48	% area	≤ 1.00	PASS
Identity — theoretical monoisotopic mass	calculated from molecular formula	1310.6248	Da	—	NOT TESTED
Identity — observed monoisotopic mass	LC-MS, high resolution (ESI-TOF/QTOF)	1310.6289	Da	—	NOT TESTED
Mass accuracy	observed vs theoretical	+3.1	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	3.89	%	≤ 8.0	PASS
Counter-ion (acetate)	anion-exchange ion chromatography	4.37	%	≤ 10.0	PASS
Residual solvent + inorganic residue	estimated — see /methods/residual-solvents-q3c/	0.32	%	—	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	4.37	—	2.5 – 8.0	PASS
Retention time (observed)	RP-HPLC, 30 min gradient	9.70	min	9.72 ± 0.25 (normalised)	PASS
Peak asymmetry (10 % height)	Ph. Eur. 2.2.46	1.08	—	0.80 – 1.50	PASS
Plate count, main peak	N = 5.54 (t/w½)²	76,854	—	≥ 20,000	PASS
Resolution to nearest impurity	vs [L-Trp6]-diastereomer (gonadorelin analogue)	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 76,854, and skew follows the reported asymmetry factor of 1.08. 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 0.48 % impurity against a 99.33 % 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	Triptorelin — main peak	9.70	4,827,746	99.33	—
2	oxidised Trp (+16 Da)	9.36	23,329	0.48	+15.995
3	[L-Trp6]-diastereomer (gonadorelin analogue)	9.50	4,374	0.09	0.000
4	ring-opened pGlu (+18 Da)	9.22	2,916	0.06	+18.011
5	des-Gly10-NH2 (−74 Da)	9.44	1,944	0.04	-74.048
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 1310.6248 Da, computed from C64H82N18O13. 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 1310.6289 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+	437.8822	437.8836	0.0014	8.6
2+	656.3197	656.3217	0.0020	51.4
1+	1311.6321	1311.6362	0.0041	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)	99.42	99.33	divergence -0.04 pp vs batch median
Total impurities (% area)	0.58	0.67
Largest single impurity (% area)	0.30	0.48
Water (%)	3.7	3.89
Counter-ion (%)	4.7	4.37
Peptide content (%w/w)	91.0	not determined
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: Buyer-sourced
Evidentiary weight: Strongest available evidence in this index.
Chain of custody: Retail purchase → submitter (ambient, 6 d) → laboratory (hand-carried, 11 d) → assay.
Assay date: 17 Feb 2026
Submitted to the index: 28 Feb 2026
Laboratory: Janoshik Analytical, Ostrava, Czechia
Method basis: 30 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 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.

buyer_sourced28 Feb 2026

Provenance and purity together are what make a figure like this usable. An independently purchased vial at 99.33 % is worth several supplier-selected ones.

sodium_adduct28 Feb 2026

Adduct bookkeeping on this one is tidy. The sodium series is present at the expected intensity ratio and has not been counted as an impurity, which happens more often than it should.

units_pedant28 Feb 2026

Reported as signed ppm, which is the right convention: direction carries information about calibration that a modulus discards.

Section 7

Related records

Same batch — lot HYB-2512-B7307 n=12

Report	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042060	HYB-2512-B7307	Janoshik	2026-Q1	99.46	3.86	94.9	Buyer-sourced	0	PASS
AX-2026-042061	HYB-2512-B7307	Medutest	2026-Q1	99.22	4.88	100.4	Laboratory-retained	0	PASS
AX-2026-042062	HYB-2512-B7307	PeptideMeter	2026-Q1	99.93	4.16	—	Buyer-sourced	0	PASS
AX-2026-042063	HYB-2512-B7307	PeptideMeter	2026-Q1	99.93	4.28	99.1	Supplier-supplied	0	PASS
AX-2026-042064	HYB-2512-B7307	Medutest	2026-Q1	99.46	4.18	90.0	Buyer-sourced	1	FAIL
AX-2026-042065	HYB-2512-B7307	Medutest	2026-Q1	99.40	4.83	—	Buyer-sourced	1	MARGINAL
AX-2026-042066	HYB-2512-B7307	Medutest	2026-Q1	99.48	4.68	—	Buyer-sourced	1	FAIL
AX-2026-042067	HYB-2512-B7307	Medutest	2026-Q1	99.60	4.31	105.3	Buyer-sourced	0	PASS
AX-2026-042068	HYB-2512-B7307	Janoshik	2026-Q1	99.38	4.40	88.8	Buyer-sourced	1	MARGINAL
AX-2026-042070	HYB-2512-B7307	Janoshik	2026-Q1	99.41	4.43	—	Buyer-sourced	0	PASS
AX-2026-042071	HYB-2512-B7307	PeptideMeter	2026-Q1	99.49	4.78	106.6	Buyer-sourced	0	PASS

Batch rollup and reproducibility assessment →

Cross-sections

Other recent Triptorelin records in the index.
Report	Supplier	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-041477	QSC	QSC-2607-C5749	Nordanalyt	2026-Q3	99.53	3.42	—	Buyer-sourced	0	PASS
AX-2026-042060	HYB	HYB-2512-B7307	Janoshik	2026-Q1	99.46	3.86	94.9	Buyer-sourced	0	PASS
AX-2026-042068	HYB	HYB-2512-B7307	Janoshik	2026-Q1	99.38	4.40	88.8	Buyer-sourced	1	MARGINAL
AX-2026-042063	HYB	HYB-2512-B7307	PeptideMeter	2026-Q1	99.93	4.28	99.1	Supplier-supplied	0	PASS
AX-2026-042062	HYB	HYB-2512-B7307	PeptideMeter	2026-Q1	99.93	4.16	—	Buyer-sourced	0	PASS
AX-2026-042061	HYB	HYB-2512-B7307	Medutest	2026-Q1	99.22	4.88	100.4	Laboratory-retained	0	PASS
AX-2026-042064	HYB	HYB-2512-B7307	Medutest	2026-Q1	99.46	4.18	90.0	Buyer-sourced	1	FAIL
AX-2026-042065	HYB	HYB-2512-B7307	Medutest	2026-Q1	99.40	4.83	—	Buyer-sourced	1	MARGINAL

Other recent HYB records in the index.
Report	Compound	Lot	Lab	Quarter	Purity %	Water %	Recovery %	Provenance	Flags	Result
AX-2026-042083	MOTS-c	HYB-2606-D7858	Medutest	2026-Q3	99.93	2.02	—	Buyer-sourced	0	PASS
AX-2026-042090	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.57	2.36	—	Buyer-sourced	1	FAIL
AX-2026-042084	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.28	2.79	107.3	Buyer-sourced	0	PASS
AX-2026-042087	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.54	3.05	—	Buyer-sourced	0	PASS
AX-2026-042085	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.51	2.31	—	Buyer-sourced	0	PASS
AX-2026-042088	MOTS-c	HYB-2606-D7858	PeptideMeter	2026-Q3	99.22	2.21	—	Buyer-sourced	0	PASS
AX-2026-042086	MOTS-c	HYB-2606-D7858	Janoshik	2026-Q3	99.93	3.02	—	Buyer-sourced	1	MARGINAL
AX-2026-042091	CJC-1295 with DAC	HYB-2608-E7391	Janoshik	2026-Q3	99.38	5.53	—	Buyer-sourced	0	PASS