Pharmaceutical microbiology plays a critical role in ensuring the quality and safety of pharmaceutical products. Microorganisms can contaminate products, potentially harming patients and compromising product efficacy. Therefore, controlling and preventing contamination is essential to ensure product safety and this can be achieved through the process of Risk Assessment.Risk assessment is a systematic process that identifies,…
Development of an appropriate dissolution method for quality control purposes requires consideration of many factors and a balance of different needs. The method is typically distinctive to each drug product because of the unique characteristics of the active ingredient, the formulation, and the manufacturing process. Dissolution testing of solid oral dosage forms has been used…
Yesterday, I started working through the Noyes-Whitney equation with the intrinsic dissolution rate (k2). Today, let’s discuss the impact of surface area on dissolution. The equation shows us that as the surface area of a formulation increases, so does the dissolution rate. Using this, a formulator can greatly increase or decrease the dissolution rate of…
Scaling up the tablet dosage form preparation process, particularly through wet granulation, is a critical task in pharmaceutical manufacturing. As we transition from pilot to production scales, managing liquid addition is crucial to maintaining consistent dissolution profiles and ensuring tablet efficacy. Here’s an expanded view on how to effectively handle this process. Challenges in Scaling…
Expiration date: The date placed on the container/labels of an API designating the time during which the API is expected to remain within established shelf-life specifications if stored under defined conditions and after which it should not be used. Retest date: The date when a material should be reexamined to ensure that it is still…
HEPA (High-Efficiency Particulate Air) and ULPA (Ultra-Low Penetration Air) filters are both advanced filtration systems designed to remove particulate matter from the air, but they differ in efficiency, applications, and cost. Filtration Efficiency: HEPA filters capture 99.97% of particles as small as 0.3 microns, making them highly effective for general use in cleanrooms, medical facilities,…
1. Dose– Definition: The specific amount or quantity of a medication administered at one time – Examples:– 500mg of Paracetamol– 10mg of Amlodipine– 20 units of Insulin – Key Point: Dose refers to the exact amount of drug given at once 2. Dosage– Definition: The amount of medication and the frequency of administration over a…
The calculation of peak purity in HPLC (High-Performance Liquid Chromatography) is typically performed using a photodiode array (PDA) detector, which can detect absorbance at multiple wavelengths simultaneously. Steps : Collect Spectral Data Across the Peak: During HPLC analysis, a PDA detector collects the UV-visible spectrum at different points across the peak (start, apex, and end…
