HPLC-UV — Identity confirmation and purity determination by chromatographic analysis.
Scope: active pharmaceutical ingredient (API), impurities profiling.
Reference standard: in-house validated standard, CAS 70-18-8.
Results
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Identity (Glutathione)
Confirmed — RT 5.3 min
Purity (HPLC-UV)
99.4%
Impurity A (RT 2.8 min)
0.4%
Impurity B (RT 9.7 min)
0.2%
Total impurities
0.6%
Specification
Purity ≥ 98.0% · All impurities ≤ 1.0%
Overall result
PASS — Meets specification
HPLC chromatogram — HPLC-UV absorbance (mAU) vs. retention time (min) · Batch VP-GSH-2504A · 17 APR 2025
Comments
The main peak at RT 5.3 min was confirmed as Glutathione by retention time match against reference standard (CAS 70-18-8).
All detected impurities are below the individual reporting threshold of 1.0%.
No unspecified impurities exceeding 0.10% were detected.
This report is issued for research purposes only and is valid for the submitted sample only.
Analysis conducted ›17 APR 2025
Signature ›
M. Janošík
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