ISO 13646:2025 PDF

Overview

ISO 13646:2025 specifies validated laboratory methods for the determination of selected estrogens in whole water samples using solid phase extraction (SPE) followed by liquid chromatography (LC) or gas chromatography (GC) coupled to mass spectrometry (MS) detection. The standard covers SPE (disk or cartridge) sample preparation and instrumental analysis by tandem MS (MS/MS) or high-resolution MS (HRMS). It is designed for ultra‑trace hormone analysis in drinking water, groundwater and surface water (including suspended particulate matter and dissolved organic carbon up to specified limits).

Relevant SEO keywords: ISO 13646:2025, water quality standard, estrogen determination, SPE LC-MS/MS, GC-MS/MS, ultra-trace analysis, whole water samples.

Key Topics and Requirements

• Target analytes: Five selected estrogens (including 17α‑ethinylestradiol, EE2); see Table 1 in the standard for full list.
• Sample matrices: Whole water (drinking water, groundwater, surface water); methods can be extended to treated wastewater if validated.
• Sample constraints: Applicable for SPM up to 500 mg/L and DOC up to 14 mg/L.
• Analytical techniques: SPE disk/cartridge extraction; LC-MS/MS, LC‑HRMS, GC‑MS/MS, GC‑HRMS detection; derivatization options for GC where required.
• Performance ranges: Verified limits of quantification (LOQ) vary by analyte and matrix - e.g., EE2 LOQ range 0.006 ng/L to 1 ng/L; other estrogens 0.038 ng/L to 1 ng/L. Upper working range typically tens of ng/L.
• Quality control: Procedures for calibration (including isotope dilution), blanks, recovery calculations, LOQ determination, QA/QC and performance data reporting are specified.
• Supporting material: Informative annexes provide example SPE protocols, clean‑up procedures, LC‑MS/MS and GC‑MS/MS/HRMS methods.

Applications

• Environmental monitoring of estrogenic compounds in surface and groundwater.
• Compliance assessment relative to ecological quality standards (EQS) or predicted no-effect concentrations (PNEC).
• Evaluation of drinking water safety and treatment performance (e.g., removal efficiency in wastewater treatment).
• Research on endocrine-disrupting substances, fate and transport, and ecological risk assessments.

Note: For measurements at very low concentrations (between the lowest LOQ and 0.1 ng/L), all procedural steps - sampling, extraction, clean‑up, instrument sensitivity and sample storage - become critical and must be strictly controlled and validated.

Who should use this standard

• Accredited environmental and analytical laboratories
• Water utilities and drinking water laboratories
• Regulatory agencies and environmental monitoring programs
• Research institutions and consultants working on micropollutant monitoring

Related standards

Consult the normative references listed in ISO 13646:2025 and documents from ISO/TC 147 (Water quality) for complementary methods and guidance on sampling, QA/QC and laboratory practices.