Content Uniformity | PharmaBharat Tools

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Content Uniformity | PharmaBharat Tools

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Acceptance Criteria Analytical Method Active Pharmaceutical Ingredient(API)Assay Bacterial Endotoxins Bracketing Certificate of Analysis(CoA)Child-Resistant Packaging Comparability Container Closure Integrity(CCI)Container Closure System(CCS)Content Uniformity Control Strategy Critical Process Parameter(CPP)Critical Quality Attribute(CQA)Critical Material Attribute(CMA)Design Space Dissolution Drug Product(DP)Drug Substance(DS)Elemental Impurity Excipient Extractables and Leachables(E&L)Forced Degradation Hold Time Study Impurity In-Process Control(IPC)In-Use Stability Matrixing Analytical Method Transfer Method Validation Nitrosamine Impurity Particulate Matter Photostability Process Analytical Technology(PAT)Process Characterisation Quality by Design(QbD)Raw Material Reference Standard Release Specification Residual Solvent Retest Period Scale-Up Shelf Life Shelf-Life Specification Specification Stability Chamber Stability-Indicating Method Stability Protocol Stability Study Stability Trending Starting Material Tamper-Evident Packaging Technology Transfer

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RA CMCContent Uniformity

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Container Closure System (CCS)Control Strategy

Content Uniformity

CMC

Definition

A test ensuring dosage units contain the intended amount of active ingredient within defined acceptance criteria.

Regulatory source

ICH Q6A; pharmacopeial content uniformity requirements