ISO 12787:2011 PDF

Name: ISO 12787:2011 — Cosmetics — Analytical methods — Validation criteria for analytical results using chromatographic techniques
SKU: ISO 12787:2011
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Cosmetics — Analytical methods — Validation criteria for analytical results using chromatographic techniques

Название (английский):

ISO 12787:2011

Cosmetics — Analytical methods — Validation criteria for analytical results using chromatographic techniques

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 20
Дата публикации:: 13 декабря 2011 г.
Издание:: ISO IS 12787 edition 1 version 1
ICS:: 71.100.70

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Описание (английский):

ISO 12787:2011 defines validation criteria with which analytical results obtained from the analysis of cosmetic products should comply in order to give confidence in performance, reliability and quality of the final result. It sets out an analytical approach that can be used by a single laboratory to carry out chromatographic analyses on a given sample, or samples.

Abstract

Похожие стандарты

Другие стандарты ISO

Overview

ISO 12787:2011 - Cosmetics - Analytical methods - Validation criteria for analytical results using chromatographic techniques provides a pragmatic, single-laboratory approach to validating chromatographic analyses of cosmetic products. The standard defines the validation criteria and a three-step workflow (standard solutions, sample screening, assays) to ensure confidence in performance, reliability and quality of analytical results for complex cosmetic matrices.

Key topics and technical requirements

Three-step analytical approach

Step 1: Minimum validation on standard solutions (apparatus checks, LoD/LoQ estimation, linearity, calibration, accuracy).
Step 2: Sample screening to evaluate analyte presence and approximate concentration.
Step 3: Assays for quantification using spike recovery or full assay procedures depending on detectability.

Limits of detection and quantification

LoD estimated from noise (S/N ≈ 3); LoQ typically defined as S/N ≈ 10 (as explained in the standard).

Calibration and controls

Use of a solvent standard calibration curve (at least five levels) and independent control standards to verify calibration.

Matrix considerations

Definitions and handling of PrEMS (pre-extraction spiked matrix standards) and PoEMS (post-extraction spiked matrix standards) to distinguish matrix effect from extraction yield.
Guidance to apply standard-addition or matrix-matched approaches when matrix effects are significant.

Performance characteristics

Evaluation of specificity, selectivity, precision (repeatability/intermediate precision), accuracy (bias/recovery), linearity, working range, measurement uncertainty, peak asymmetry and resolution.

Decision tree and annexes

A decision tree guides whether to adapt methods or proceed to screening/assay. Annex A and B provide example weighting selection and simplified assay options.

Practical applications

Validating chromatographic methods (e.g., GC, HPLC) used to quantify ingredients, impurities, preservatives or trace contaminants in cosmetic formulations.

Establishing laboratory acceptance criteria for routine QC, stability testing, or regulatory submissions.

Distinguishing analytical failure from true absence of an analyte via spike recovery and matrix checks.

Determining working range, LoD/LoQ and uncertainty for single-lab method validation.

Related standards and guidance (applicable)

ISO 12787:2011 is intended to be used alongside general laboratory best practices and accreditation guidance. Laboratories commonly pair it with broader laboratory management and analytical method validation frameworks to meet regulatory and quality system requirements.

Keywords: ISO 12787:2011, cosmetics analytical methods, chromatographic validation, LoD, LoQ, matrix effect, PrEMS, PoEMS, calibration curve, precision, accuracy.

ISO 12787:2011 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications

Who should use ISO 12787:2011

Related standards and guidance (applicable)

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