Fillers in tableting Strictly speaking, fillers should only fill up the missing tablet mass and be as inert as possible. This means that they should not interact with the API or other necessary excipients. Functional fillers However, it makes no sense to add inert substances which are non-binding or have no other functionality. That’s why…
The International Generic Drug Regulators Programme (IGDRP) brings together regulatory authorities from different countries and regions to harmonize and standardize practices for generic drug evaluation. Dissolution testing is a critical part of this process, ensuring the quality and bioequivalence of generic formulations across global markets. Below are the key dissolution requirements typically considered by IGDRP…
As per USP (24 ± 2°C), BP (20-25°C) and other pharmacopeia, the pH of the sample/substance was measured at the temperature near by 25°C. Because temperature plays a crucial role in the pH of the substance. How the temperature changes the pH value: pH is defined as the negative logarithm of H+ ion concentration. It…
Autoclave validation is a critical process in pharmaceutical manufacturing to ensure effective sterilization. Among the various tools used, Biological Indicators (BIs) stand out as the gold standard for confirming sterilization efficacy. Why Biological Indicators Matter Biological indicators contain highly resistant microbial spores (e.g., Geobacillus stearothermophilus) that serve as a benchmark to validate whether the autoclave…
Headspace is used to analyze volatile compounds in liquid and solid samples that cannot be injected directly into a gas chromatograph (GC). Examples would be creams and lotions, blood, soil, electronic components, and polymers. Headspace sampling can accommodate virtually any matrix. The Headspace Sampling Process Sample is transferred to a vial suitable for headspace analysis…
1. Key Parts of 21 CFR Relevant to CSV 21 CFR Part 11: Key aspects include: 21 CFR Part 820: 21 CFR Part 211: 2. Applying 21 CFR in CSV Planning Phase System Requirements Definition: Risk Assessment: Validation Activities Validation Plan: Design Qualification (DQ): Installation Qualification (IQ): Operational Qualification (OQ): Performance Qualification (PQ): Documentation and…
Persistent Challenges in Tablet Production If sticking or overlubrication is a permanent problem during tablet production, a useful alternative can be the external lubrication of the punches and dies. It is a standard add-on for modern rotary tablet presses. How Does External Lubrication Work? A nozzle sprays dry lubricant just before the feeder onto punches…
Nitrosamines are potential carcinogens that can form in drug products through different pathways. Regulatory authorities such as the USFDA, EMA, and WHO mandate a thorough risk assessment to identify, mitigate, and control nitrosamine impurities in products. Key Steps in Nitrosamine Risk Assessment: Identify Potential Risk Factors: Evaluate Potential Pathways of Formation: Perform Analytical Testing: Risk…
