Showing posts with label Stability. Show all posts

Stability Study Failures and Investigations in Pharmaceuticals

Stability studies are extremely important scientific and regulatory functions in the pharmaceutical industry because they define your produc...

Validation of Stability Chambers in Pharmaceuticals | Complete Guide

Stability testing represents one of the most critical components of the pharmaceutical industry as it establishes how long a drug product ca...

Climatic Zones for Stability Studies in Pharmaceuticals

Stability study is an important part of pharmaceutical product quality. For safety, efficacy and quality of pharmaceutical products, environ...

Understanding the Stability of Injectable Products

Stability of pharmaceutical products is important to make those stable, safe and effective for a long time. When it comes to antibiotics, va...

Resolving API Impurity Issues in Drug Development

Active pharmaceutical ingredients are the main part of every pharmaceutical product because these are the active content in any drug formula...

Strategies for Resolving Stability Issues in Drug Formulations

The stability of pharmaceutical products plays an important role in the effectiveness of drug products and patient safety. An unstable pharm...

Determination of Hot and Cold Spot in Stability Chamber

Everything from pharmaceutical products to personal consumer products is tested in stability chambers to get an accurate reading of conditi...

ICH Guidelines for Pharmaceuticals | Complete Overview with Examples

ICH (Full form = International Council on Harmonization) was formed in 1990 in collaboration of regulatory authorities of US, Europe and Jap...

SOP for Stability Studies of Finished Goods

1.0 OBJECTIVE To lay down the procedure for collection, storage and analysis of stability samples of finished products. 2.0 SCOPE This ...

Effect of Humidity Level on Tablet Stability

The level of humidity greatly affects the stability of tablets. Tablets and capsules are protected for moisture by their packing. Degradatio...

Forced Degradation Study in Pharmaceutical Stability

Forced degradation is also known as stress testing and a drug is degraded forcefully by applying artificial methods. It is a useful tool to ...

Mean Kinetic Temperature (MKT) in Stability Studies

Mean Kinetic Temperature is a useful tool used in pharmaceutical stability studies . It helps to calculate the degradation of stability samp...

Impurity Profiling of Drug Substances in Pharmaceuticals

The description, characterization and quantitation of the identified and unidentified impurities present in new drug substances are known ...

Process of Finding Impurities in Pharmaceutical Products

The primary goal of any synthetic process is to create completely pure products, though in reality the marginal amount of impurity always ...

Significant Change in Pharmaceutical Stability Testing

Stability of the pharmaceutical products is determined by storing the product under Accelerated and Long Term Conditions. The product is t...

Shelf Life Estimation of Pharmaceutical Products

All pharmaceutical drugs degrade with the time forming the byproducts. These byproducts may harmful to the health of the patients consuming...

Guidelines for Pharmaceutical Stability Study

Following are the guidelines for stability study conduction for new products: 1. Formal stability study should consist of accelerated and ...