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Document set current to 30 July 2026
Bibliographic record

ICH Q2(R2) Validation of Analytical Procedures

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline 2023

Document identifier
CEI-BR-047
Series
Bibliographic record
Version
1.0
Published
30 Jul 2026
Last reviewed
30 Jul 2026
Certainty
Not rated

§1Bibliographic record

§1.1Record

Authors
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Title
ICH Q2(R2) Validation of Analytical Procedures
Source
ICH Harmonised Guideline
Year
2023
Volume, issue, pages
Step 4 version, 1 November 2023
Digital object identifier
not held by the Institute
PubMed identifier
not held by the Institute
Record type
Guideline
Institute identifier
CEI-BR-047

§1.2Institute documents citing this record

Table 1. Documents in the Institute set that cite this record.

DocumentSeries
Standard CEI-MS-01: Determination of chromatographic purity of synthetic peptides by…Methodological standard
Standard CEI-MS-02: Confirmation of peptide identity by liquid chromatography–tandem mass…Methodological standard
Standard CEI-MS-03: Determination of peptide content and its distinction from…Methodological standard
Standard CEI-MS-08: Related-substances profiling and the detection of isobaric impuritiesMethodological standard
Standard CEI-MS-10: Identification and quantification of counter-ions in synthetic…Methodological standard
Standard CEI-MS-12: Residual solvent determination by static headspace gas chromatographyMethodological standard
Standard CEI-MS-13: Development and validation of a stability-indicating method for…Methodological standard
Standard CEI-MS-14: Certificate-of-analysis minimum data standard for synthetic peptide…Methodological standard
Standard CEI-MS-15: Protocol for independent third-party verification of a supplied…Methodological standard
Standard CEI-MS-19: Purity determination for peptides not retained by conventional…Methodological standard
Standard CEI-MS-20: Photostability assessment of light-sensitive peptidesMethodological standard
Synthesis: Dependence of reported purity on the analytical methodEvidence synthesis
12 citing documents.

§1.3Subject tags

validation method ich

Compound Evidence Institute · CEI-BR-047 · https://compoundevidence.com/bibliography/ichq2/ · retrieved 30 July 2026
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