AssayIndex

AX-2026-043196

L-Carnosine · 500 mg declared · GL Biochem (Shanghai) Ltd. · lot GLBI-2512-S8068

PASSMETHOD LIMITED
Report ID
AX-2026-043196
Compound
L-Carnosine
Compound class
Short bioregulator peptides
Supplier
GL Biochem — GL Biochem (Shanghai) Ltd.
Batch / lot
GLBI-2512-S8068
Declared label claim
500mg
Laboratory
Medutest
Assay date
22 May 2026
Submitted
30 May 2026
Quarter
2026-Q2
Submitter
r.duarte
Sample provenance
Supplier-supplied
Section 1

Results

Measured against the index acceptance specification for the short bioregulator 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, 25 min gradient, 214 nm99.86% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.14% area≤ 1.0PASS
Largest single impurityRP-HPLC — D-carnosine epimer0.06% area≤ 1.00PASS
Identity — theoretical monoisotopic masscalculated from molecular formula226.1066DaNOT TESTED
Identity — observed monoisotopic massLC-MS, unit resolution (single quadrupole)226.1079DaNOT TESTED
Mass accuracyobserved vs theoretical+5.8ppm± 20PASS
Total peptide contentby difference from the gravimetric mass balance91.05%w/wNOT TESTED
Target-compound contenttotal peptide content × purity90.92%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen503.12mg500 mg declaredNOT TESTED
Recovered target peptidegross fill × target content457.437mg500 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim91.5%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate8.60%≤ 12.0PASS
Counter-ionno ionisable counter-ion expectedN/Anot applicableNOT TESTED
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.35%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 lyophilised cake, intactwhite to off-white intact cakePASS
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration6.132.5 – 8.0PASS
Retention time (observed)RP-HPLC, 25 min gradient3.14min3.15 ± 0.20 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.150.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²78,341≥ 20,000PASS
Resolution to nearest impurityvs D-carnosine epimer1.09no 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.

09585191702875538340 L-Carnosine3.14 min · 99.86 % 3.09 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 0481216202428 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 25 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 78,341, and skew follows the reported asymmetry factor of 1.15. 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 0.06 % impurity against a 99.86 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1L-Carnosine — main peak3.144,853,50699.86
2D-carnosine epimer3.092,9160.060.000
3β-alanine (−137 Da)2.962,4300.05-137.059
4free histidine (−71 Da)3.011,4580.03-71.037
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 226.1066 Da, computed from C9H14N4O3. All ppm figures on this site are against monoisotopic values — see why that matters.

0255075100175200225250275300 [M+1H]1+227.12 m/z Relative abundance (%)
Figure 2. ESI charge-state envelope, unit-resolution instrument. Sticks are placed at m/z = (M + z × 1.007276)/z for the observed neutral mass of 226.1079 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 (%)
1+227.1139227.11520.0013100.0
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 Fischer8.60
Counter-ionnone expected0.00
Residual solvent + inorganic residueestimated0.35
Total peptide contentby difference91.05
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)99.4599.86divergence -0.15 pp vs batch median
Total impurities (% area)0.550.14
Largest single impurity (% area)0.290.06
Water (%)7.18.60
Counter-ion (%)not statedN/A
Peptide content (%w/w)not stated91.05
Endotoxin (EU/mg)0.33not determined
Method stated on certificateYEScolumn, 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
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
22 May 2026
Submitted to the index
30 May 2026
Laboratory
Medutest, Ljubljana, Slovenia
Method basis
25 min gradient · unit-resolution MS
Verification status
METHOD LIMITED
Section 6

Annotations 2

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.

area_percent
Area percent assumes unit response factors across every species present. At 99.86 % the assumption barely matters — there is not enough impurity for a response-factor error to move the figure by a tenth.
gradient_25
The gradient is on the record, which is the first thing that should be true of any purity figure and often is not. 25 min at Medutest puts this comparison on a documented footing.
Section 7

Related records

Same batch — lot GLBI-2512-S8068 n=9

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043188GLBI-2512-S8068PeptideMeter2026-Q299.628.43Buyer-sourced0PASS
AX-2026-043189GLBI-2512-S8068Medutest2026-Q299.608.49Buyer-sourced0PASS
AX-2026-043190GLBI-2512-S8068Janoshik2026-Q299.468.66Buyer-sourced0PASS
AX-2026-043191GLBI-2512-S8068Janoshik2026-Q299.608.38Buyer-sourced1MARGINAL
AX-2026-043192GLBI-2512-S8068Janoshik2026-Q299.288.71106.8Buyer-sourced0PASS
AX-2026-043193GLBI-2512-S8068Medutest2026-Q299.938.4891.9Buyer-sourced0PASS
AX-2026-043194GLBI-2512-S8068Janoshik2026-Q299.628.1690.4Buyer-sourced0PASS
AX-2026-043195GLBI-2512-S8068Janoshik2026-Q299.168.6989.4Laboratory-retained1MARGINAL
Other recent L-Carnosine records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043257CPCCPC-2603-G9615VendorInvestigate2026-Q398.2010.41102.2Buyer-sourced0FAIL
AX-2026-043256CPCCPC-2603-G9615Janoshik2026-Q399.0210.17104.1Supplier-supplied0PASS
AX-2026-043258CPCCPC-2603-G9615Medutest2026-Q398.9510.1597.8Buyer-sourced0FAIL
AX-2026-043189GL BiochemGLBI-2512-S8068Medutest2026-Q299.608.49Buyer-sourced0PASS
AX-2026-043190GL BiochemGLBI-2512-S8068Janoshik2026-Q299.468.66Buyer-sourced0PASS
AX-2026-043194GL BiochemGLBI-2512-S8068Janoshik2026-Q299.628.1690.4Buyer-sourced0PASS
AX-2026-043195GL BiochemGLBI-2512-S8068Janoshik2026-Q299.168.6989.4Laboratory-retained1MARGINAL
AX-2026-043188GL BiochemGLBI-2512-S8068PeptideMeter2026-Q299.628.43Buyer-sourced0PASS
Other recent GL Biochem records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-043179Kisspeptin-10GLBI-2608-N7715Medutest2026-Q398.974.37Buyer-sourced1MARGINAL
AX-2026-043178Kisspeptin-10GLBI-2608-N7715Janoshik2026-Q398.504.55Buyer-sourced1MARGINAL
AX-2026-043166L-Glutathione (reduced)GLBI-2606-S7352Janoshik2026-Q399.018.84105.4Laboratory-retained1MARGINAL
AX-2026-043184Kisspeptin-10GLBI-2608-N7715Janoshik2026-Q398.993.63100.6Supplier-supplied1MARGINAL
AX-2026-043185Kisspeptin-10GLBI-2608-N7715Medutest2026-Q398.713.71107.0Buyer-sourced1MARGINAL
AX-2026-043165L-Glutathione (reduced)GLBI-2606-S7352Medutest2026-Q399.478.60Supplier-supplied1MARGINAL
AX-2026-043182Kisspeptin-10GLBI-2608-N7715Janoshik2026-Q398.933.8695.7Buyer-sourced1MARGINAL
AX-2026-043183Kisspeptin-10GLBI-2608-N7715PeptideMeter2026-Q398.544.17102.2Buyer-sourced1MARGINAL