Pharma Digest
Impurity Specification Across Different Regulatory Bodies
Impurities in pharmaceutical products play a critical role in ensuring drug quality, safety, and efficacy. Regulatory bodies such as the USFDA, EMA, PMDA, and others have specific guidelines for identifying, quantifying, and controlling impurities. Types of Impurities Key Guidelines for Impurity Control USFDA EMA PMDA (Japan) WHO Indian Pharmacopeia Differences ... Read More
Justification for Control of Elemental Impurities in Formulation
Introduction Definition: Elemental impurities are trace levels of metals that can be introduced into drug products from raw materials, manufacturing processes, or container closure systems. Regulatory requirement: ICH Q3D and relevant pharmacopeial guidelines (USP <232>, <233>) specify acceptable limits for elemental impurities to ensure patient safety. Identification of Potential Sources ... Read More
Trend Analysis for Elemental Impurities
Trend analysis for elemental impurities is not explicitly required by guidelines like ICH Q3D . However, certain aspects of stability trends and variability need to be considered to ensure compliance and accurate reporting. Stability Trends for Elemental Impurities In most cases, if no such risk is identified, monitoring for trends ... 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
Powder Shape and Their Effect on Tablet Properties
The pharmaceutical industry relies heavily on powders for the formulation of solid dosage forms, particularly tablets. Powder properties, including particle size and shape, directly affect the manufacturing process and the performance of the final product. While particle size has been extensively studied, the influence of particle shape has garnered increasing ... Read More
Does an F2 Similarity Value of 50 Mean the Two Dissolution Profiles are Only 50% Similar?
No, the similarity factor (F2) is a mathematical representation of the quadratic mean difference between two dissolution profiles across all considered time points. An F2 value of 50 indicates that the two profiles differ by a small margin, with a mean difference of approximately 10%. The similarity factor is not ... Read More
Mind Mapping Tool for Investigations
Mind mapping can be an incredibly effective tool in pharmaceutical investigations, helping teams structure their thinking, uncover connections, and generate insights systematically. Here’s how it can be applied effectively: Applications of Mind Mapping in Pharmaceutical Investigations Root Cause Analysis: During investigations of deviations, out-of-specification (OOS) results, or adverse events, mind ... 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
Key Considerations for Generic Formulation Development
Generic formulation development is a complex process designed to create bioequivalent, cost-effective alternatives to innovator products while meeting regulatory standards. Below are the critical aspects to consider: Regulatory Compliance Ensure adherence to market-specific regulatory guidelines, such as those of USFDA, EMA, or MHRA, to obtain approval for generic products. Bioequivalence ... Read More
Concepts of Elimination Rate and Clearance of Drugs
Have we come across a presenter who commented that the ‘clearance rate of a drug is high or low’? A question arises: Is clearance an elimination rate of a given drug? Some of us remain unclear regarding the concepts of elimination rate and clearance of drugs. Elimination rate is the ... Read More