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Amorphous vs Crystalline API — Selection Criteria for Formulation

Amorphous vs Crystalline API — Selection Criteria for Formulation

Trade-offs between amorphous and crystalline API forms for solubility, stability, and manufacturability.

Elemental Impurities — ICH Q3D Risk Assessment Approach

Elemental Impurities — ICH Q3D Risk Assessment Approach

A practical risk-assessment approach to elemental impurities in drug substances and products under ICH Q3D.

Genotoxic Impurities — Control Strategy per ICH M7

Genotoxic Impurities — Control Strategy per ICH M7

How to assess and control potentially mutagenic impurities in APIs under the ICH M7 framework.

Hygroscopicity Testing — Method and Impact on API Storage

Hygroscopicity Testing — Method and Impact on API Storage

How hygroscopicity is classified and tested, and what it means for API packaging and storage conditions.

Ibuprofen — Polymorphism and Crystal Form Considerations

Ibuprofen — Polymorphism and Crystal Form Considerations

How crystal form and polymorphism affect Ibuprofen API processability, dissolution behavior, and formulation choices.

Metformin HCl — Analytical Method for Assay by HPLC

Metformin HCl — Analytical Method for Assay by HPLC

HPLC assay method outline for Metformin Hydrochloride, including chromatographic conditions and system suitability approach.

Paracetamol API — Specification and Impurity Profile

Reference specification for Paracetamol drug substance covering identity, assay, related substances, and packaging/storage requirements per the applicable pharmacopoeial monograph.

Particle Size Distribution — Analytical Method and Acceptance Criteria

Particle Size Distribution — Analytical Method and Acceptance Criteria

Laser diffraction method outline for API particle size distribution and how acceptance criteria are set.

Reference Standards — Qualification and Requalification Procedure

Reference Standards — Qualification and Requalification Procedure

How primary and working reference standards are qualified, assigned potency, and requalified over time.

Residual Solvents in APIs — ICH Q3C Classification Guide

Residual Solvents in APIs — ICH Q3C Classification Guide

Overview of the ICH Q3C solvent classes and how they drive residual solvent limits and testing strategy for drug substances.