Limit test

Limit Tests

A limit test is a type of analytical method used to determine whether a specific impurity or substance in a pharmaceutical product is present at a concentration below a predefined acceptable limit. Limit tests are typically employed when the impurity or substance is not expected to be present in significant amounts, or when the impurity … Read more

Impurities in pharmaceutical substances

Impurities in pharmaceutical substances

Impurities in pharmaceutical substances are unwanted chemicals or compounds in pharmaceutical substances that can affect the drug’s quality, safety, and efficacy. They are classified into organic, inorganic, or residual solvent impurities and can originate from various sources. Sources of Impurities in pharmaceutical substances 1) Starting Materials and Reagents: Impurities may arise from impure raw materials, … Read more

Pharmacopoeia

Pharmacopoeia

A pharmacopoeia is an authoritative collection of standards and guidelines for the quality, purity, and strength of drugs, excipients, and dosage forms. It outlines the composition, preparation, storage, and labelling requirements of pharmaceutical products, serving as a reference for healthcare professionals. History of Pharmacopoeia 1) Early Compilations: Early examples include “De Materia Medica” by Dioscorides … Read more