Analytical Development
How to Design Forced Degradation Studies?
Most Forced degradation studies are started with a generic checklist: acid, alkali, peroxide, heat, light etc. But forced degradation is not about “covering conditions.” It is about understanding how your drug product is actually likely to break down. Here’s a practical way to approach it: 𝗦𝘁𝗲𝗽 𝟭: 𝗚𝗮𝘁𝗵𝗲𝗿 𝗽𝗿𝗶𝗼𝗿 𝗸𝗻𝗼𝘄𝗹𝗲𝗱𝗴𝗲 ... Read More
Invisible Discriminatory Parameter in Dissolution
It’s not rpm, it’s your dissolution specs – Q value + time point. Sceptical? Well here’s a case study that makes this obvious. In this study, dissolution was run on Progesterone 100 mg Soft gelatin capsules. Dissolution profiles of two Test batches with different API particle sizes – Test 1 ... Read More
Safe Impurity Limit for Pharmaceuticals
The fastest way to sabotage your own submission? Set impurity limits to “look safe” Both sides think they’re protecting the product. Sometimes both are wrong! Here’s what actually happens: Set the limit too tight – based on early data: What started as a ‘conservative’ decision now stretches your development timeline. ... Read More
Dissolution Method Validation Across Multiple Strengths
Last week I came across a LinkedIn post claiming you can validate one ‘pseudo/ worst-case strength’ because same API = same method performance. While it’s true that ‘representative’ strengths ARE used in method validation. But for dissolution, this assumption is an oversimplification to the point where it’s not correct. Why? ... Read More
Global Product Development | Key Steps and Common Mistakes
1. Product Identification & Target Market Definition Steps: Common Mistakes: 2. API and Excipient Selection Steps: Common Mistakes: 3. Formulation Development Steps: Common Mistakes: 4. Analytical Development Steps: Common Mistakes: 5. Stability and Compatibility Studies Steps: Common Mistakes: 6. Process Optimization and Scale-Up Steps: Common Mistakes: 7. Bioequivalence and Clinical ... Read More
R&D Guide to Dissolution Specification Setting
Setting dissolution specifications at the R&D stage is a critical step in pharmaceutical product development. It ensures that the formulation will consistently meet performance expectations and regulatory requirements. Here’s a clear step-by-step guide: How to Set Dissolution Specifications in R&D 1. Understand the Role of Dissolution Dissolution testing predicts how ... Read More
What Should Flow Through HPLC Column?
What Should You Flow, and What Shouldn’t in HPLC? It Depends on Your Column! What you flow, what you avoid flowing, and in what order, all depend on your column’s stationary phase and physical parameters. Let’s break it down scientifically: Stationary Phase Chemistry 1. Reversed-phase columns (like C18): 2. Normal-phase ... Read More
Troubleshooting in HPLC | A Detective Game in the Lab
Even the best HPLC methods sometimes run into trouble. Poor peak shapes? pressure spikes? incorrect retention times? You need to identify define the problem, define which component(s) may be causing it, then solve it. This process is called troubleshooting. It’s an art as much as it is a science. Think ... Read More
Ways to Extend the Lifespan of C18 Columns & Guard Columns
Use a Guard Column Filter and Degas Mobile Phase Use Proper pH and Buffer Conditions Regular Column Flushing Avoid Prolonged Exposure to Aqueous Buffers Inject Clean Samples Optimize Flow Rate and Pressure General Precautions Before Cleaning Initial Rinse (Removing Buffer and Salts) Purpose: To remove any buffer salts that may ... Read More
Sink Factor in Dissolution Testing
Dissolution testing is a cornerstone of pharmaceutical development, providing invaluable insights into how drugs behave in the body. One critical aspect often overlooked is the sink factor and its pivotal role in ensuring the accuracy and relevance of dissolution results. What is Sink Factor? Sink factor refers to the ratio ... Read More
One Product Development for Multiple Markets
Developing a single product for multiple markets requires careful planning to meet the regulatory requirements of each target region. Identify Target Markets & Regulatory Authorities Each country or region has its own regulatory body that sets guidelines for pharmaceutical products. Key regulatory agencies include: Each authority has different requirements for ... Read More