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Document set current to 30 July 2026
Bibliographic record

ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline 1999

Document identifier
CEI-BR-049
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 Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Source
ICH Harmonised Tripartite Guideline
Year
1999
Volume, issue, pages
Step 4 version
Digital object identifier
not held by the Institute
PubMed identifier
not held by the Institute
Record type
Guideline
Institute identifier
CEI-BR-049

§1.2Institute documents citing this record

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

DocumentSeries
Monograph: DulaglutideCompound monograph
Monograph: EcnoglutideCompound monograph
Monograph: Maridebart cafraglutideCompound monograph
Monograph: TeduglutideCompound monograph
Monograph: IGF-1 LR3Compound monograph
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-04: Determination of water content in lyophilised peptides by coulometric…Methodological standard
Standard CEI-MS-10: Identification and quantification of counter-ions in synthetic…Methodological standard
Standard CEI-MS-11: Determination of aggregate content by size-exclusion chromatographyMethodological standard
Standard CEI-MS-14: Certificate-of-analysis minimum data standard for synthetic peptide…Methodological standard
Standard CEI-MS-21: Freeze–thaw and in-use stability assessment of reconstituted peptide…Methodological standard
Synthesis: Completeness of certificates of analysis in the research-supply…Evidence synthesis
Synthesis: Counter-ion content and its effect on delivered peptide massEvidence synthesis
Synthesis: Dulaglutide in type 2 diabetes mellitus: effect on the anchor outcomeEvidence synthesis
Synthesis: Teduglutide in inflammatory bowel disease and mucosal barrier…Evidence synthesis
Synthesis: Dulaglutide in atherosclerotic cardiovascular disease and…Evidence synthesis
Synthesis: Maridebart cafraglutide in obesity and overweight in adults: effect…Evidence synthesis
Synthesis: Dulaglutide in type 2 diabetes mellitus: tolerability and…Evidence synthesis
Synthesis: Teduglutide in inflammatory bowel disease and mucosal barrier…Evidence synthesis
Synthesis: Dulaglutide in atherosclerotic cardiovascular disease and…Evidence synthesis
Synthesis: Maridebart cafraglutide in obesity and overweight in adults…Evidence synthesis
Synthesis: Dulaglutide in type 2 diabetes mellitus: durability of effectEvidence synthesis
Synthesis: Teduglutide in inflammatory bowel disease and mucosal barrier…Evidence synthesis
24 citing documents.

§1.3Subject tags

specifications ich

Compound Evidence Institute · CEI-BR-049 · https://compoundevidence.com/bibliography/ichq6b/ · retrieved 30 July 2026
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