ISO 15819:2014

Overview

ISO 15819:2014 specifies an analytical method for the detection and quantification of N‑nitrosodiethanolamine (NDELA) in cosmetics and raw materials used in cosmetics. The method uses high performance liquid chromatography with tandem mass spectrometric detection (HPLC‑MS‑MS) and is focused exclusively on NDELA - it is not applicable to other nitrosamines or to products outside the cosmetics/raw‑material domain. The standard is intended for targeted quantitative determination where contamination or in‑situ formation of NDELA is suspected and is not intended as a routine screening protocol for all finished products.

Key topics and technical requirements

• Analytical principle: Extraction of NDELA with water in the presence of a deuterated internal standard (d8‑NDELA), followed by clean‑up and HPLC‑MS‑MS analysis. Identification uses the molecular ion plus two diagnostic fragment ions; quantification is by ion‑ratio vs. calibration curve.
• Sample clean‑up options:
  • Solid phase extraction (SPE) with a C18 cartridge (reversed phase)
  • Liquid–liquid extraction (DCM) for non‑dispersible samples
• Standards and calibration: Example calibration range given is 1.0–80.0 ng/ml using at least five standards; internal standard d8‑NDELA at 20 ng/ml in calibration solutions.
• Apparatus and consumables: HPLC‑MS‑MS with electrospray ionization; analytical reversed‑phase C18 column (example: 100 mm × 2.1 mm, 5 µm); SPE C18 cartridges; high‑quality HPLC‑MS solvents and reagents.
• Safety and storage: N‑nitrosamines are potent carcinogens - operations require fume hood/glove box, appropriate PPE, and safe hazardous‑waste disposal. NDELA standards and extracts must be stored protected from light and temperature controlled.
• Matrix considerations: Because cosmetics are diverse, the method may need adaptation for particular matrices. If matrix effects occur, standard addition or additional validation per ISO 12787 may be required.
• Validation and reporting: The standard references ISO 12787 for validation criteria (recovery, detection/quantification limits, accuracy) and specifies procedures for calibration, R‑value determination and result calculation.

Applications and users

• Who uses it: cosmetic manufacturers, raw‑material suppliers, contract analytical laboratories, and regulatory/control laboratories investigating potential NDELA contamination or formation.
• Typical uses: targeted forensic testing, ingredient qualification, root‑cause investigations after a suspected contamination event, and R&D checks when ingredient interactions might produce NDELA.

Related standards

• ISO 12787:2011 - validation criteria for chromatographic analytical results (matrix effects, recovery, LOD/LOQ).
• ISO 3696:1987 - water for analytical laboratory use (quality of water for sample prep).

Keywords: ISO 15819:2014, NDELA, N‑nitrosodiethanolamine, HPLC‑MS‑MS, cosmetics, nitrosamines, SPE, liquid–liquid extraction, analytical method.