API
Understanding D50 in Particle Size Distribution of API – Why It Matters!
Chief Pharmacist
In pharmaceutical development, Particle Size Distribution (PSD) is a critical quality attribute—especially for Active Pharmaceutical Ingredients (APIs). Among the PSD ...
API Particle Size Distribution (PSD) Matters in Generic Formulations
Chief Pharmacist
In generic oral solid dosage forms, API particle size distribution is not just a physical parameter—it is a critical material ...
API/Drug Substance Selection in Generic Development – Key Points
Chief Pharmacist
With 15 years of experience in formulation research and technology transfer, I’ve seen how critical it is to finalize the ...
API Impurity Specification
Chief Pharmacist
In making medicines, setting impurity limits for the Active Pharmaceutical Ingredient (API) is a key step to ensure quality and ...