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Pharmaceutical Guidelines

Top 10 Tips for Microbial Limit Test

The microbial limit test is the quantitative and qualitative assessment of the microbes in a sample. This test is performed for:- estimation of the total viable count of fungi and bacteria i.e. Quantitative estimation. Identification of each of the microbes of importance by culturing on selective …

Causes and Remedies of Binding in Tablet Manufacturing

Tablet manufacturing involves a series of processes all aimed at the result of a uniform fine piece of art tablet. This article aims at exploring the causes and remedies of binding in tablet manufacturing. The processes include sizing, milling, drying, and compressing among several other procedure…

Differences between Syrups and Suspensions

Do you know that all pharmaceutical syrups are not manufactured equally? If you don’t, then don’t scratch your head. In fact, there is a subtle difference in these products that can cause ineffective use in clinical effects. Pharmaceutical syrup generally can be broken down into different categori…

10 Tips for HPLC Analysis In Pharmaceuticals

HPLC, also known as High-Performance Liquid Chromatography, is one of the most crucial analytical methods in pharmaceuticals. It is used in the separation of each compound that make up a mixture.
It passes pressurized liquid solvent with the use of pumps which holds the sample mixture via a column…

Causes and Remedies of Sticking in Tablet Manufacturing

The tablet production process has become more simplified and more mechanized with the development of technology. However, the complexity of a tablet punching process has increased. But relatively the problems associated with the tablet manufacturing process have not yet been significantly reduced.

Top 10 Tips for Sterility Test

Sterility is a critical test in sterile pharmaceutical manufacturing. there are a lot of chances of errors in this test due to the requirement of highly aseptic conditions during the process. The analyst must be careful about the contamination during the handling of the sample and sterile equipmen…

Difference between Sustained Release and Prolonged Release Tablets

The words sustained release and prolonged release can be used interchangeably because they mean the same thing. But the difference between sustained release tablets and prolonged release tablets is surely evident.

Revalidation of Equipment and Process in Pharmaceuticals

Revalidation in the pharmaceutical industry is very important as it helps to maintain the validated status of the equipment, plant, manufacturing process as well as the computer systems. This procedure is necessary for periodic checking of the validation results according to the revalidation perio…

Granulation Process in Pharmaceutical Manufacturing

Granulation is a process of producing granules generally. In pharmaceutical manufacturing, granulation process implies the techniques that are, used to combine powdered particles to form relatively bigger ones called granules. This process is used for commercial production of tablets.

Validation of the Effectiveness of UV Light in Water System

UV radiation is an important component when it comes to the control of microbial contamination. To ensure the efficiency of UV light in purified water is kept at optimum, most of the time, validation of effective working of UV light in pharmaceutical water system needs to be carried out.

Steps for HPLC Method Validation

In the pharmaceutical industry, validation is an essential part of quality control and quality assurance. Various regulatory authorities give particular emphasis on the validation of all the processes used in the industry. Validation is a formal and systematic way to demonstrate the suitability of…

Requirements of FDA for Training in Pharmaceuticals

The FDA compels every drug or medical devices manufacturer to train every employee starting with the regulated procedures to the CFR requirements. The FDA training requirements in pharmaceuticals are defined in 21 CFR 211.25 and have three key aspects:

Causes and Remedies of Cracking in Tablet Manufacturing

Cracking is a situation in which small cracks are identified on the top and bottom central surfaces of tablets during the processing of the tablets or during their subsequent use. Hardly are the cracks identified on the sides of the tablets but mainly on the top and bottom surfaces.

Causes and Remedies of Lamination in Tablet Manufacturing

An ideal tablet should be free from any visual defects as well as the functional defects. Despite the advancements and innovations in the manufacturing of tablets, the problems that are often encountered in the production have not decreased but instead increased. And this is mainly due to the comp…

Different Types of Dissolution Apparatus

Drug dissolution testing is usually used on a regular basis in the quality control department of any pharmaceutical company. This method is used to monitor the quality of the capsules and tablets that are produced. A drug can only go into the market if only it passes a dissolution test and is appr…

Difference Between Paddle and Basket Dissolution

When a drug is ingested orally, it takes some time to dissolve in the stomach and get absorbed by the body. The rate at which the drug dissolves inside the stomach affects the drug's concentration in the blood as it gets absorbed. If it dissolves too fast it may cause an over-dosage, and if it…

About the Author

Ankur Choudhary is experienced in pharmaceutical, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.


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