AssayIndex

AX-2026-043597

Tesamorelin · 2 mg declared · PolyPeptide Group (Hangzhou) Co., Ltd. · lot PPG-2608-A6835

PASSIDENTITY CONSISTENT
Report ID
AX-2026-043597
Compound
Tesamorelin
Compound class
Growth-hormone axis peptides
Supplier
PPG — PolyPeptide Group (Hangzhou) Co., Ltd.
Batch / lot
PPG-2608-A6835
Declared label claim
2mg
Laboratory
Janoshik Analytical
Assay date
31 Jul 2026
Submitted
02 Aug 2026
Quarter
2026-Q3
Submitter
al.villalobos
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.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 30 min gradient, 214 nm98.54% area≥ 97.0PASS
Total impuritiesRP-HPLC, sum of reported peaks1.46% area≤ 3.0PASS
Largest single impurityRP-HPLC — des-hexenoyl GRF (1-44) (−96 Da)0.71% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula5131.9276DaNOT TESTED
Identity — observed monoisotopic massLC-MS, high resolution (ESI-TOF/QTOF)5131.9533DaNOT TESTED
Mass accuracyobserved vs theoretical+5.0ppm± 15PASS
Peptide contentnot ordered on this submissionnot determinedrequired to check label claimNOT TESTED
Water contentKarl Fischer, coulometric, duplicate1.15%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography3.49%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.61%NOT TESTED
Endotoxinnot ordered on this submissionnot determined≤ 5.0NOT TESTED
Sterilitynot ordered on this submissionnot determinedno growthNOT TESTED
Appearancevisual, diffuse light, black and white backgroundWhite cake, partial shrinkage from vial wallwhite to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear after 90 s gentle swirling, no particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration5.522.5 – 8.0PASS
Retention time (observed)RP-HPLC, 30 min gradient15.53min15.44 ± 0.40 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.260.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²59,527≥ 20,000PASS
Resolution to nearest impurityvs deamidated (+1 Da)1.07no 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.

01586317247586343 Tesamorelin15.53 min · 98.54 % 14.11 same trace · ×50 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 59,527, and skew follows the reported asymmetry factor of 1.26. 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 0.71 % impurity against a 98.54 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Tesamorelin — main peak15.534,789,34998.54
2des-hexenoyl GRF (1-44) (−96 Da)14.1134,5080.71-96.058
3deamidated (+1 Da)15.2515,0670.31+0.984
4Met sulfoxide (+16 Da)14.8911,1790.23+15.995
5truncated (1-40)13.6510,2070.21-488.259
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 5131.9276 Da, computed from C221H366N72O67S. All ppm figures on this site are against monoisotopic values — see why that matters.

025507510060080010001200140016001800 [M+5H]5+1027.40[M+4H]4+1284.00[M+6H]6+856.33 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 5131.9533 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 (%)
7+734.1398734.14350.00378.0
6+856.3285856.33280.004349.5
5+1027.39281027.39790.0051100.0
4+1283.98921283.99560.006455.1
3+1711.64981711.65840.00867.7
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.

FigureSupplier COAThis reportIndex note
Purity (% area)99.3198.54divergence +0.57 pp vs batch median
Total impurities (% area)not stated1.46
Largest single impurity (% area)not stated0.71
Water (%)0.41.15
Counter-ion (%)not stated3.49
Peptide content (%w/w)not statednot determined
Endotoxin (EU/mg)not statednot determined
Method stated on certificateNOno 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 (2–8 °C, 2 d) → laboratory (courier, ambient, 11 d) → assay.
Assay date
31 Jul 2026
Submitted to the index
02 Aug 2026
Laboratory
Janoshik Analytical, Ostrava, Czechia
Method basis
30 min gradient · high-resolution MS
Verification status
IDENTITY CONSISTENT
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 PPG-2608-A6835 n=3

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043596PPG-2608-A6835PeptideMeter2026-Q398.741.83105.1Buyer-sourced1MARGINAL
AX-2026-043598PPG-2608-A6835Kestrel2026-Q398.912.56100.3Buyer-sourced1FAIL
Other recent Tesamorelin records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-042704ERPERP-2604-W9463Janoshik2026-Q399.024.08Buyer-sourced1MARGINAL
AX-2026-043598PPGPPG-2608-A6835Kestrel2026-Q398.912.56100.3Buyer-sourced1FAIL
AX-2026-043596PPGPPG-2608-A6835PeptideMeter2026-Q398.741.83105.1Buyer-sourced1MARGINAL
AX-2026-043380WXTWXT-2601-A2974Medutest2026-Q197.173.0691.5Buyer-sourced0PASS
AX-2025-021018WXTWXT-2505-B3939Janoshik2025-Q396.863.7795.9Buyer-sourced1FAIL
AX-2025-019141GSPGSP-2501-G3708VendorInvestigate2025-Q198.134.76Buyer-sourced0PASS
AX-2025-019137GSPGSP-2501-G3708PeptideMeter2025-Q198.064.56Buyer-sourced0PASS
AX-2025-019142GSPGSP-2501-G3708Medutest2025-Q198.314.5396.0Buyer-sourced0PASS
Other recent PPG records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043598TesamorelinPPG-2608-A6835Kestrel2026-Q398.912.56100.3Buyer-sourced1FAIL
AX-2026-043596TesamorelinPPG-2608-A6835PeptideMeter2026-Q398.741.83105.1Buyer-sourced1MARGINAL
AX-2026-043605RetatrutidePPG-2604-X7060Janoshik2026-Q298.174.2999.7Buyer-sourced0PASS
AX-2026-043601RetatrutidePPG-2604-X7060Janoshik2026-Q298.283.9695.3Buyer-sourced0PASS
AX-2026-043668AOD-9604PPG-2602-W8018PeptideMeter2026-Q299.473.06Buyer-sourced0PASS
AX-2026-043670AOD-9604PPG-2602-W8018PeptideMeter2026-Q299.562.71104.5Buyer-sourced0PASS
AX-2026-043630CJC-1295 (no DAC)PPG-2512-D7211Janoshik2026-Q299.665.1192.5Buyer-sourced0PASS
AX-2026-043660MGFPPG-2512-G7713Janoshik2026-Q299.304.2595.8Buyer-sourced0PASS