
Tag: General Article
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STUDY OF PHYSICOCHEMICAL INTERACTIONS OF PHARMACEUTICAL EXCIPIENTS AND ACTIVE PHARMACEUTICAL INGREDIENT (API)
PHYSICOCHEMICAL INTERACTIONS OF PHARMACEUTICAL EXCIPIENTS INTRODUCTION Physicochemical interactions of pharmaceutical excipients and active pharmaceutical ingredient lead to formation of molecular complexes, increase in rate of…
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PHARMACEUTICAL EXCIPIENT; A REVIEW
A pharmaceutical excipient is any ingredient in a drug product other than the active pharmaceutical ingredient (API) used to aid in the manufacturing process but…
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Extraneous Peaks in Chromatographic analyses
Extraneous peaks are defined as Unwanted and unexpected peaks that appear in a chromatogram but are not related to the analyte being measured. Extraneous Peaks By the…
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PHARMACEUTICALS PROCESS VALIDATION
Pharmaceuticals Process Validation is the means of ensuring and providing documentary evidence that processes within their specified design parameters are capable of repeatedly andreliably producing…
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SAMPLING AND TESTING IN PROCESS VALIDATION BATCHES IN PHARMACEUTICALS
Sampling and testing in process validation batches in pharmaceuticals refers to selecting a portion of a pharmaceutical product for a defined purpose, such as quality…
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DATA INTEGRITY ISSUES IN PHARMACEUTICALS COMMON OBSERVATIONS, CHALLENGES AND MITIGATION STRATEGIES
Data integrity issues in pharmaceuticals industry: Common observations, challenges and mitigations strategies Data integrity (DI) reaffirms the pharmaceutical industry’s commitment to manufacture drugs that are safe, effective…
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NEW TRENDS IN THE APPLICATION OF FUMIGATION METHOD IN MEDICAL AND NON-MEDICAL FIELDS
The action or process of disinfecting or purifying an area with the fumes of certain chemicals is fumigation method in medical and non-medical fields. Introduction…
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Analyzing FDA form 483 data: Identifying trends and areas of concern in regulatory compliance
Analyzing FDA form 483 data: Identifying trends and areas of concern in regulatory compliance in pharmaceuticals This study scrutinizes a dataset originating from the FDA’s…
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Current Good Manufacturing Practice cGMP and the Concepts of Modern Quality Systems
Current Good Manufacturing Practice, a set of regulations that ensure the quality, purity, and consistency of pharmaceutical products and other regulated goods. It’s a key…
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cGMP Guideline for Packing Material in Pharmaceuticals
cGMP Guideline for Packing Material in pharmaceuticals is explain in this article. cGMP Guideline for Packing Material 1. Materials examination and usage criteria (a) Written…