Substance
APIs, excipients, and raw materials.
SubstanceAug 24, 2026
Amorphous vs Crystalline API — Selection Criteria for Formulation
Trade-offs between amorphous and crystalline API forms for solubility, stability, and manufacturability.
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SubstanceAug 24, 2026
Elemental Impurities — ICH Q3D Risk Assessment Approach
A practical risk-assessment approach to elemental impurities in drug substances and products under ICH Q3D.
SubstanceAug 24, 2026
Genotoxic Impurities — Control Strategy per ICH M7
How to assess and control potentially mutagenic impurities in APIs under the ICH M7 framework.
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SubstanceAug 24, 2026
Hygroscopicity Testing — Method and Impact on API Storage
How hygroscopicity is classified and tested, and what it means for API packaging and storage conditions.
SubstanceAug 24, 2026
Ibuprofen — Polymorphism and Crystal Form Considerations
How crystal form and polymorphism affect Ibuprofen API processability, dissolution behavior, and formulation choices.
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SubstanceAug 24, 2026
Metformin HCl — Analytical Method for Assay by HPLC
HPLC assay method outline for Metformin Hydrochloride, including chromatographic conditions and system suitability approach.
3
SubstanceAug 24, 2026
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.
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SubstanceAug 24, 2026
Particle Size Distribution — Analytical Method and Acceptance Criteria
Laser diffraction method outline for API particle size distribution and how acceptance criteria are set.
SubstanceAug 24, 2026
Reference Standards — Qualification and Requalification Procedure
How primary and working reference standards are qualified, assigned potency, and requalified over time.
SubstanceAug 24, 2026
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.
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