Pharma Specialists

API

Do API Manufacturers Need to Use the Same PSD Method as the Formulation Site?

In BCS Class II drug development, particle size distribution (PS…

January 02, 2026

API

Particle Size Distribution (PSD) of API in Oral Suspension Preparation

In the generic pharmaceutical industry, developing an oral suspe…

July 20, 2025

API

Science Behind Choosing the Right Active Ingredient in Generic Drug Development

When developing a generic medicine, one of the most critical ear…

July 11, 2025

API

How to Predict API Stability and Degradation from Its Chemical Structure

Understanding the chemical structure of an Active Pharmaceutical…

November 24, 2024

API

Conducting a Risk Assessment for API Properties in Solid Oral Formulation Development

In the pharmaceutical industry, ensuring the quality and efficac…

November 22, 2024

API

Role of API pH in Formulation Development

The pH of an Active Pharmaceutical Ingredient (API) provides cru…

November 14, 2024

API

Role of API Polymorphism in Formulation Development

Polymorphism in Active Pharmaceutical Ingredients (APIs) is a cr…

November 13, 2024

API

Understanding the Properties of the Drug Substance During Literature Search

Understanding the properties of the drug substance (also known a…

November 01, 2024

API

Critical Role of API PSD in Formulation Development

Impact on Pharmacokinetics and BCS Classification PSD is crucial…

October 31, 2024

API

Top 10 Deficiencies in New Applications for CEP for Chemical Purity

From this article you can learn how to avoid top 10 deficiencies…

March 05, 2024

API

Can We Use Expired API after Retest?

In many cases, there is confusion between Expiry Date and Rete…

March 04, 2022

API

APIC Guidance on Cleaning Validation for API Plant

The integration of Cleaning Validation within an effective Quali…

February 20, 2022