Analytical Development
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
Mastering the Art of Peak Integration in HPLC
Peak integration in High-Performance Liquid Chromatography (HPLC) is more than just a routine step—it’s the bridge between your experiment and the data-driven decisions that follow. Every peak tells a story, and accurate integration ensures you’re interpreting it correctly. Why is Peak Integration Crucial?The area under the curve (AUC) of a ... Read More
Effect of pH in Analytical Method
As a chromatographer not many of us are aware of how critical pH is in your method development, sometimes it is even considered as an inconsequential factor, which could have a negligible effect on our analysis. However, in truth pH can make or break your analysis, choosing the correct or ... Read More
Media and Buffers in Dissolution Method Development
Sink Conditions: Volume of medium should be at least 3 times that needed to form a saturated solution (USP definition). pH Range: Typical range is 1.1 to 6.8, but can be adjusted up to pH 8.0 for solubility. Common Buffers: Surfactants: Medium Deaeration: Ensure medium is deaerated to prevent bubbles, ... Read More
Discriminating Dissolution Media
Discriminating Dissolution Media is a critical component in pharmaceutical formulation development, designed to identify differences in the dissolution performance of drug products. These media are particularly useful when addressing formulation changes, variations in API properties, or manufacturing process alterations. Key Features of a Discriminating Dissolution Medium Examples of Common Discriminating ... Read More
Cetylpyridinium Chloride (CPC) in Dissolution Bath
Cetylpyridinium chloride (CPC) at 0.01% w/v is often used in a dissolution bath to maintain microbial control and ensure the cleanliness of the system. Its inclusion helps prevent microbial contamination, which could interfere with the dissolution process and affect the accuracy of drug release studies. CPC is a cationic surfactant ... Read More
Difference Between C8 and C18 Columns
C8 and C18 are both types of reverse-phase chromatography columns, but they differ in their: Carbon chain length: Hydrophobicity: Retention characteristics: Separation range: Column selectivity: In summary, C8 columns are used for smaller, more polar molecules, while C18 columns are used for larger, more non-polar molecules. The choice between C8 ... Read More
Surfactants in Dissolution
We have many factors to consider when making a dissolution method. What apparatus, speed, filter choice, etc. Of these factors, the one I get the most questions about is media selection – especially surfactants in media selection. So, what is a surfactant and why do we use them? What do ... Read More