The penetration of steam into all parts of the autoclave is essential for achieving and maintaining effective sterilization. The Bowie–Dick test is performed to verify adequate air removal and uniform steam penetration within a pre-vacuum steam autoclave, using a standardized Bowie–Dick test pack. During sterilization, air pockets and non-condensable gases may remain trapped inside the … Read more
Fumigation and fogging are commonly used in pharmaceuticals to control microbial contamination in controlled areas. Fumigation is a gaseous sterilization process that kills microorganisms and prevents microbial growth in the air or on surfaces such as walls and floors. Fumigation agents, such as formaldehyde and potassium permanganate, are often used to control microorganisms. This technique … Read more
Water is widely used in pharmaceuticals as an ingredient, solvent for processing, analytical reagent, and in the manufacturing of pharmaceutical products. So, according to pharmacopeia, different types of water are recommended as per the official book and chapter <1231>. Note: Information in this article doesn’t change the existing guidelines and regulations. It helps users understand … Read more
Modern pharmaceutical analysis relies on a range of instrumental techniques to ensure drug safety, efficacy, and regulatory compliance. Among these, UV-Visible (UV-Vis) spectrophotometry is universal in pharma R&D and QC labs. This method measures how much ultraviolet or visible light a sample absorbs, and through the Beer–Lambert law (absorbance ∝ concentration), it enables quantitation of … Read more
Below is a summary of the 10 most frequently observed audit findings in pharmaceutical manufacturing plants, followed by detailed descriptions, examples, preventive strategies, and relevant industry keywords. Each issue is based on industry reports and regulatory inspection data. Common Audit Finding: 1. Documentation and Record-Keeping Deficiencies: Deficiencies in documentation and records, such as missing or … Read more
As a pharmaceutical professional, we generally face various problems during analytical processes in our work such as HPLC, GC, IR, UV, Mass Spectroscopy, and many others. These instrumental methods are essential for the analysis of drug substances and drug products to ensure their quality, safety, and efficacy. 21 Top HPLC, GC, IR, UV, Mass Spectroscopy … Read more
Want to succeed in your next pharma interview? This is our complete guide on top most dissolution interview questions that are answered by experienced seasoned pharmaceutical professionals. Knowing these fundamental questions and responses can give you a significant advantage as a recent graduate or experienced candidate. In this article, we explore some of the most … Read more
Learn About Standard Operating Procedure for Handling of Deviations in pharmaceuticals | Types of deviations | Deviation Flow chart | Devations Guidelines | Deviation Numbering | Deviation management. 1.0 OBJECTIVE: 1.1 To lay down that deviations from manufacturing instructions and quality-related procedures are recorded, investigated, and evaluated for their impact on product quality in a … Read more
In this discussion, we will delve into two very important terms associated with drug products: drug product assay and drug product potency. The aim is to clear vision on their interrelation, differences, and significance, as guided by the ICH guideline Q2 R2, which focuses on analytical method validation. Drug Product Assay Definition and Purpose A … Read more
The instrument being discussed in this context is known as a Flow Injection Analyzer (FIA). Its primary function is to automate several processes typically associated with conventional wet chemistry procedures. Specifically, the Flow Injection Analysis is designed to perform tasks such as automatically picking up samples, mixing them with the required reagents, and subsequently detecting … Read more
A Dissolution Test is used for in vitro Testing of the Tablets and Capsules. Dissolution provides the product Release info to know the drug delivery. Dissolution apparatus are used throughout the product development life cycle, from Product release to stability testing and study of the product data from product to product. Then after passing or approval from the … Read more
Preparation and Standardization of 0.01 M Sodium Tetraphenylborate (C6H5)4BNa) solution and calculating formula in Pharmaceutical labs. Name: 0.01 M Sodium Tetraphenylborate (C6H5)4BNa) Reagents: Sodium TetraphenylborateSodium HydroxideAluminium HydroxideSodium ChlorideCetylpyridinium ChloridePotassium Chloride Method of Preparation: Method of Standardization: Calculation: The calculation formula is : Where ‘a’ is the volume of 0.005 M cetylpyridinium chloride required without potassium … Read more
Preparation and Standardization of 0.1 M Tetrabutylammonium Hydroxide (C16H37NO) Solution in Pharmaceutical Labs. Name: 0.1 M Tetrabutylammonium Hydroxide (C16H37NO) Reagents : Preparation of 0.1 M Tetrabutylammonium Hydroxide: Method of Standardization: Storage: Store below 25°C & store in an amber-colored bottle. Protect exposure from CO2 & water. Shelf life: The shelf life of the above solution … Read more
Column Cleaning, Regeneration, and Storage of Silica Based Columns are necessary to prevent unnecessary problems during the Process. So when you’re using those in-line filters or guard cartridges for your HPLC columns, it’s like giving them armor against getting clogged or stuff sticking to them. But you know what? Even with these guard things, over … Read more
Why is HPAC Mobile phase Degassing done? When different liquids mix in HPLC analysis, bubbles forming can cause problems. To avoid this, we removed the bubbles by degassing the liquid used in the analysis. Unstable and Noisy Baselines Lower flow rate precision of pump due to cavitation in piston chamber or effect on check valve … Read more
Preparation and Standardization of 0.1 N Perchloric acid (Non-Aquos by using glacial acetic acid and crystal violet solution as indicators in Pharmaceuticals. Apparatus and Reagents Requirements: Apparatus: Conical Flask, Volumetric Flask, Reflux condenser, Measuring cylinder, Burette, Pipette and Burette Stand. Reagents: Preparation of 0.1 N Perchloric acid Standardization of 0.1 N Perchloric acid Calculation: N1V1=N2V2 … Read more