Quality Control » Pharmaguddu

Common Problems and Troubleshooting for Disintegration Test Apparatus

Disintegration test troubleshooting guide showing common USP/Ph. Eur. tablet disintegration apparatus problems, causes, and corrective actions.

Have you ever asked yourself why a tablet, which has passed all the other quality control tests, fails the QC bench? A disintegration test apparatus is used to determine whether a tablet or a capsule disintegrates within a specified time under defined conditions. The test is performed by vertically reciprocating the unit in a liquid maintained at human body temperature. This article describes the working principle of the disintegration test apparatus, its components, the procedure for the disintegration test, calibration, and the disintegration limits set by the manufacturers for different dosage forms. This information will help QC and manufacturing personnel to perform the disintegration test properly and release the batches of the pharmaceutical products.

0.1M Perchloric Acid Preparation and Standardization Procedure (IP Method)

Infographic to prepare Crystal Violet Solution with step-by-step procedure, quantity of reagents, adjustment of water content, Karl Fischer testing, storage and quality control points.

Know the step-by-step procedure used to prepare and standardize 0.1M perchloric acid solution as per IP guidelines. Incorporates reagents, equipment, calculation, detection of endpoint, storage of reagents, and standardization with potassium hydrogen phthalate (KHP).

0.004 M Benzethonium Chloride Solution Preparation and Standardization Procedure

Detailed infographic for the preparation, standardization, titration principle and equivalence factor for a pharmaceutical quality control laboratory 0.004 M solution of benzethonium chloride

Preparation and standardization of 0.004 M benzethonium chloride solution with potentiometric titration with 0.1 M perchloric acid. It deals with preparation of reagents, calculation of standardizations, equivalence factor and recommendation on storage for pharmaceutical laboratory applications.

How to Prepare and Standardize 0.05 M Silver Nitrate (SOP)

Infographic showing the preparation, standardization procedure, calculations, and endpoint for 0.05 M silver nitrate solution in pharmaceutical analysis.

Here is the exact process for making and standardizing 0.05 M silver nitrate. Includes the chemicals, the titration procedure and the formula to calculate and storage condition

Preparation and Standardization of 0.025 M Sulphuric Acid Solution

Infographic of preparation and standardization of Sulphuric acid solution 0.025M with anhydrous sodium carbonate showing preparation steps, titration procedure, methyl red indicator, calculation formula and laboratory apparatus.

Know how to prepare 0.025 M sulphuric acid solution using anhydrous sodium carbonate, methyl red indicator, calculations and titration procedure.

How Perform Limit Test for Heavy Metals (SOP)

Complete reagent preparation guide for LIMIT TEST FOR HEAVY METALS ( BP) - steps for preparation of acetate buffer pH 3.5, thioacetamide reagent, lead standard solutions, hydrochloric acid, ammonia, phenolphthalein.

Limit tests for heavy metals need not be confusing. This guide includes detailed protocols with equipment, reagent preparation and step-by-step instructions to perform a typical test procedure. For all of the Test A, B, C and D options, there are clear instructions to ensure your pharmaceutical quality control is accurate and on track. 1.0 Scope: … Read more

How to Perform Solubility Test

Infographic on solubility test procedure and guideline in pharmaceutical quality control; preparation of sample, choice of solvent, dissolution steps, solubility classification table, laboratory apparatus and reagents, and testing conditions.

The solubility test is a basic test performed in the pharmaceutical laboratory to assess the solubility of a substance in a given solvent. This guide describes the entire solubility testing procedure, apparatus used, considerations for selection of solvents, temperature, and standard solubility classification from very soluble to practically insoluble. This step-by-step reference will help you to test accurately and fulfil the pharmaceutical quality requirements.

Bowie Dick Test for Autoclave Validation

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 in Pharmaceutical

Visual Guide on Fogging vs Fumigation Comparison

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

Types of Water in Pharmaceutical, Usage and Technique to Prepare

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

Ultraviolet and Visible Spectrophotometer in Pharmaceutical Analysis

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

Top 10 Common Audit Findings in Pharmaceutical Manufacturing

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

Procedure for Handling of Deviations (SOP)

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

Understanding Drug Product Assay and Potency

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