AssayIndex

AX-2026-042068

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

MARGINALVERIFIED
Report ID
AX-2026-042068
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
26 Mar 2026
Submitted
09 Apr 2026
Quarter
2026-Q1
Submitter
d.ogunleye
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 30 min gradient, 214 nm99.38% area≥ 98.5PASS
Total impuritiesRP-HPLC, sum of reported peaks0.62% area≤ 1.5PASS
Largest single impurityRP-HPLC — ring-opened pGlu (+18 Da)0.28% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula1310.6248Da—NOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)1310.6200Da—NOT TESTED
Mass accuracyobserved vs theoretical-3.7ppm± 15PASS
Total peptide contentby difference from the gravimetric mass balance91.88%w/w—NOT TESTED
Target-compound contenttotal peptide content × purity91.31%w/w—NOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen4.86mg5 mg declaredNOT TESTED
Recovered target peptidegross fill × target content4.438mg5 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim88.8%90.0 – 110.0FAIL
Water contentKarl Fischer, coulometric, duplicate4.40%≤ 8.0PASS
Counter-ion (acetate)anion-exchange ion chromatography2.81%≤ 10.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.91%—NOT TESTED
Endotoxinkinetic chromogenic LAL0.37EU/mg≤ 5.0PASS
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 d—no growthPASS
Appearancevisual, diffuse light, black and white backgroundOff-white lyophilised cake, intact—white to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear after 90 s gentle swirling, no particulates—clear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.67—2.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient9.62min9.72 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.09—0.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²34,399—≥ 20,000PASS
Resolution to nearest impurityvs [L-Trp6]-diastereomer (gonadorelin analogue)0.94—no index criterionREPORTED
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.

02122424563678490 Triptorelin9.62 min · 99.38 % 9.14 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 05101520253035 Retention time (min) Response (mAU)
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 34,399, and skew follows the reported asymmetry factor of 1.09. 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 0.28 % impurity against a 99.38 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Triptorelin — main peak9.624,830,17699.38—
2ring-opened pGlu (+18 Da)9.1413,6090.28+18.011
3[L-Trp6]-diastereomer (gonadorelin analogue)9.4210,2070.210.000
4des-Gly10-NH2 (−74 Da)9.363,8880.08-74.048
5oxidised Trp (+16 Da)9.282,4300.05+15.995
Closure check — purity + Σ impurities 100.00CLOSES

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.

025507510032552572592511251325 [M+1H]1+1311.63[M+2H]2+656.32 m/z Relative abundance (%)
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 1310.6200 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.
ChargeTheoretical m/zObserved m/zΔ m/zRel. abundance (%)
3+437.8822437.8806-0.00167.9
2+656.3197656.3173-0.002451.5
1+1311.63211311.6273-0.0048100.0
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.

ComponentDetermination%w/w of cake
WaterKarl Fischer4.40
Counter-ion (acetate)ion chromatography2.81
Residual solvent + inorganic residueestimated0.91
Total peptide contentby difference91.88
Total100.00 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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.4299.38divergence -0.04 pp vs batch median
Total impurities (% area)0.580.62
Largest single impurity (% area)0.300.28
Water (%)3.74.40
Counter-ion (%)4.72.81
Peptide content (%w/w)91.091.88
Endotoxin (EU/mg)not stated0.37
Method stated on certificateNO—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 → third-party forwarder (33 d) → laboratory (courier, cold pack, 6 d) → assay.
Assay date
26 Mar 2026
Submitted to the index
09 Apr 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
VERIFIED
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.

aspartimide
Aspartimide formation at an Asp-Gly or Asp-Ser motif shows up as a pair of late-eluting satellites. They are not present above the reporting threshold on this trace.
retest_date
A retest date on the certificate would tell you what the supplier is actually asserting about stability. Purity at 99.38 % on assay day is a starting condition, not a shelf life.
buyer_sourced
Anyone can generate one of these. That is the argument the index makes on its submission page and it is the reason the dataset grows without any supplier's cooperation.
Section 7

Related records

Same batch — lot HYB-2512-B7307 n=12

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042060HYB-2512-B7307Janoshik2026-Q199.463.8694.9Buyer-sourced0PASS
AX-2026-042061HYB-2512-B7307Medutest2026-Q199.224.88100.4Laboratory-retained0PASS
AX-2026-042062HYB-2512-B7307PeptideMeter2026-Q199.934.16—Buyer-sourced0PASS
AX-2026-042063HYB-2512-B7307PeptideMeter2026-Q199.934.2899.1Supplier-supplied0PASS
AX-2026-042064HYB-2512-B7307Medutest2026-Q199.464.1890.0Buyer-sourced1FAIL
AX-2026-042065HYB-2512-B7307Medutest2026-Q199.404.83—Buyer-sourced1MARGINAL
AX-2026-042066HYB-2512-B7307Medutest2026-Q199.484.68—Buyer-sourced1FAIL
AX-2026-042067HYB-2512-B7307Medutest2026-Q199.604.31105.3Buyer-sourced0PASS
AX-2026-042069HYB-2512-B7307Janoshik2026-Q199.333.89—Buyer-sourced0PASS
AX-2026-042070HYB-2512-B7307Janoshik2026-Q199.414.43—Buyer-sourced0PASS
AX-2026-042071HYB-2512-B7307PeptideMeter2026-Q199.494.78106.6Buyer-sourced0PASS

Cross-sections

Other recent Triptorelin records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041477QSCQSC-2607-C5749Nordanalyt2026-Q399.533.42—Buyer-sourced0PASS
AX-2026-042060HYBHYB-2512-B7307Janoshik2026-Q199.463.8694.9Buyer-sourced0PASS
AX-2026-042063HYBHYB-2512-B7307PeptideMeter2026-Q199.934.2899.1Supplier-supplied0PASS
AX-2026-042062HYBHYB-2512-B7307PeptideMeter2026-Q199.934.16—Buyer-sourced0PASS
AX-2026-042061HYBHYB-2512-B7307Medutest2026-Q199.224.88100.4Laboratory-retained0PASS
AX-2026-042064HYBHYB-2512-B7307Medutest2026-Q199.464.1890.0Buyer-sourced1FAIL
AX-2026-042065HYBHYB-2512-B7307Medutest2026-Q199.404.83—Buyer-sourced1MARGINAL
AX-2026-042069HYBHYB-2512-B7307Janoshik2026-Q199.333.89—Buyer-sourced0PASS
Other recent HYB records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042083MOTS-cHYB-2606-D7858Medutest2026-Q399.932.02—Buyer-sourced0PASS
AX-2026-042090MOTS-cHYB-2606-D7858Janoshik2026-Q399.572.36—Buyer-sourced1FAIL
AX-2026-042084MOTS-cHYB-2606-D7858Janoshik2026-Q399.282.79107.3Buyer-sourced0PASS
AX-2026-042087MOTS-cHYB-2606-D7858Janoshik2026-Q399.543.05—Buyer-sourced0PASS
AX-2026-042085MOTS-cHYB-2606-D7858Janoshik2026-Q399.512.31—Buyer-sourced0PASS
AX-2026-042088MOTS-cHYB-2606-D7858PeptideMeter2026-Q399.222.21—Buyer-sourced0PASS
AX-2026-042086MOTS-cHYB-2606-D7858Janoshik2026-Q399.933.02—Buyer-sourced1MARGINAL
AX-2026-042091CJC-1295 with DACHYB-2608-E7391Janoshik2026-Q399.385.53—Buyer-sourced0PASS