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, vaccines or other injectables, these must remain chemically and physically stable from the manufacturing stage to administration. Unlike the oral dosage forms, injectables bypass the body’s natural filters; therefore, any degradation product can lead to serious…

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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 formulation. The presence of impurities in any active pharmaceutical ingredient during product development always remains a concern for product safety and regulatory compliance. Identification and control of these impurities are not only required for regulatory comp…

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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 pharmaceutical product can degrade and produce toxic byproducts those can lead to fatal consequences.

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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 conditions to be stored in. This process is absolutely foremost to be considered for FDA approval, the FDA requires proper testing and evidence of tests performed to monitor how products react, taking temperature, humidity and various other conditions into account.

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ICH Guidelines for Pharmaceuticals

ICH (Full form = International Council on Harmonization) was formed in 1990 in collaboration of regulatory authorities of US, Europe and Japan. ICH is a committee that provides the pharmaceutical stability guidelines for industries. ICH stability guidelines for stability conditions and testing are followed throughout the world for product quality. Now ICH has global players like US-FDA, EMA (EU),…

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What Do You Need to Know About the Stability of Injectable Drugs

The stability of injectables in pharmaceuticals is a paramount concern to all pharmaceutical companies. The degree of stability determines how long the drug can maintain its original potency and hence affects the quantity, efficacy and cost-effectiveness of pharmaceuticals.

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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 SOP shall be applicable to Quality Control Dept.
3.0 RESPONSIBILITY Supervisor Quality Control

4.0 ACCOUNTABILITY Sr. Manager Quality Assurance
5.0 PROCEDURE 5.1 The responsibility for collection, storage and analysis of stability samples and recommendations (if…

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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. Degradation of tablets and capsules starts when they get a high moisture content and this also appears in their physical appearance too. There are different ways through which tablet stability is affected as discussed in this article.

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Climatic Zones for Stability Studies

The climate is different in all the countries in the world. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. According to the ICH guidelines for stability studies, the climate of the world is divided into five different zones.
ICH Stability Zones Zone Type of Climate Zone I Temperate zone
Zone II Mediterranean/subtropical zone Zone III Hot dr…

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