It’s because of physics, chemistry and history. These chromophores have strong UV absorption around 254 nm due to π → π* transitions. Besides: Classical TLC plates often contained fluorescein, that fluoresced at 254 nm (“F254” plates). Compounds that absorbed at 254 nm appeared as dark spots on a fluorescein plate. And since TLC chemists almost…
1. Introduction 2. Historical Context and Regulatory Push 3. Understanding the Three Pillars 3.1 Quality by Design (QbD) – The Framework Key Concepts: Stages of Application: Early development → Technology transfer → Lifecycle management. Regulatory Basis: ICH Q8(R2), Q9, Q10, Q11, Q12, Q13, Q14. Tools: Risk assessments (FMEA, Ishikawa, Fault Tree Analysis), control strategy design….
Concepts Link: CMAs of the API directly affect CQAs of the injectable product. Key CMAs of API for Injectables Key CQAs of Injectable Products CMA → CQA Link Example – Corticosteroid Depot Injection Takeaway Read also: Resource Person: Moinuddin Syed. Ph.D, PMP®
Viscosity plays a particularly critical role—especially when the goal is to demonstrate bioequivalence (BE) with a Reference Listed Drug Key functions of viscosity in suspensions: Bioequivalence Considerations BE studies are conducted to ensure that the rate and extent of drug absorption from a generic product are comparable to that of the RLD. For BCS Class…
Every successful generic drug starts with one essential step — understanding the innovator. Innovator Product Testing is where science meets strategy. Before formulation begins, this stage provides a complete technical blueprint of the reference product. Here’s what it entails: 1. Physical Testing — More Than Just Dimensions We analyze the innovator tablet for: These parameters…
In generic drug development, the materials you source dictate everything downstream—from formulation consistency and regulatory approval to long-term commercial viability. “Your sourcing strategy is not just a procurement exercise—it’s a regulatory foundation.” Here’s what a smart, compliant, and inspection-ready sourcing strategy looks like: 1. Use Only Commercial-Grade Raw Materials Why it matters? Using research-grade or…
