In the Bacterial Endotoxins Test (BET), incubating reaction tubes at 37°C ± 1 for exactly 60 ± 2 minutes is a key step. But why such specific conditions? Let’s dive in. 1. Optimal Enzyme Activity The heart of BET lies in the Limulus Amebocyte Lysate (LAL) reagent, sourced from horseshoe crab blood. This enzyme reacts…
In pharmaceutical formulation development, finalizing the tablet weight is not a routine or arbitrary decision. It is a strategic choice that can significantly impact bioequivalence outcomes, patient compliance, manufacturing efficiency, and regulatory acceptance. This decision is influenced by multiple factors. Here’s how development teams typically approach it: Innovator (RLD) Tablet Weight as a Benchmark The…
In pharmaceutical tablet manufacturing granule size plays a critical role in ensuring smooth processing, uniformity, flowability, and compressibility. The optimal granule size depends on multiple factors, including the tablet weight, dosage form type, API properties, and manufacturing method. While there is no strict one-size-fits-all rule, certain guidelines are generally followed based on tablet weight ranges….
Chromatography columns are crucial components in separation techniques, and they vary based on the type of chromatography used. Below are the main types of chromatography columns: Liquid Chromatography (LC) Columns Used in HPLC (High-Performance Liquid Chromatography) and UHPLC (Ultra-High-Performance Liquid Chromatography). Common types include: Gas Chromatography (GC) Columns Supercritical Fluid Chromatography (SFC) Columns Chiral Columns…
Analytical Chromatography Preparative Chromatography Diagnostic Chromatography Research Chromatography Read also: Resource Person: Hamideh Mousavi
When we think of blending APIs and excipients, we think of uniformity, efficiency, and harmony. But what if I told you there’s an invisible force that can ruin your blend even before compression? Yes — Static Electricity. And it’s not just a physics problem. It’s a formulation nightmare. Let’s go deeper Why static charge forms…
The expiry date printed on your medicines isn’t arbitrary—it’s carefully determined through rigorous stability studies to ensure the drug remains safe and effective throughout its shelf life. Here’s a breakdown of how it’s done: Step 1: Stability Studies Pharmaceutical companies test drugs under controlled conditions to monitor: These studies are performed using samples stored under…
Granule particle size plays a pivotal role in drug dissolution, especially for BCS Class 2 (low solubility, high permeability) and BCS Class 4 (low solubility, low permeability) drugs. Here’s how: Key Factors to Consider: 1. Surface Area vs. Dissolution Rate: 2. Porosity and Wetting: 3. Granule Size Distribution: Why It Matters for BCS Class 2…
