What are impurities Slideshare?

What are impurities Slideshare?

IMPURITIES Impurities defined as a foreign particle that affects the purity of a substance. Usually, impurities occurring in many pharmaceutical or medicinal preparations may be of the following types. • Foreign particle that bring about adverse or toxic reactions when present in excess beyond their limits.

What is identification threshold and qualification threshold?

The identification threshold is the level at which an impurity must be structurally identified. The qualification threshold is the level at which the impurity in the drug product must be qualified for safety.

What are the sources of impurities?

The various sources of impurity in pharmaceutical products are — reagents, heavy metals, ligands, catalysts, other materials like filter aids, charcoal, and the like, degraded end products obtained during \ after manufacturing of bulk drugs from hydrolysis, photolytic cleavage, oxidative degradation, decarboxylation.

Which are the tests for purity?

Some of the analytical purity testing methods include titration, infrared spectroscopy, paper chromatography, and optical rotation, among others. These are some of the strategies used in testing the presence of impurities in chemical compounds.

What is effect of impurities?

Impurities may lower the shelf life of the substances. Impurities may cause difficulties during formulations and use of the substances. Sometimes Impurities changes the physical and chemical properties of the substances. It may change odour, colour, taste of the substance.

What are organic impurities?

Organic impurities are often process-related or drug-related pharmaceutical impurities. These types of contaminants are most likely to arise during the synthesis, purification, and storage of the drug substance.

What are the effects of impurity?

Impurities may lower the shelf life of the substances. Impurities may cause difficulties during formulations and use of the substances. Sometimes Impurities changes the physical and chemical properties of the substances. Therapeutic effect can be decreased.

What do you mean by impurity profile?

4. Definition :  The description , characterization and quantitation of identified and unidentified impurities present in the drug substances is known as impurity profile.  IMPURITIES in pharmaceuticals are unwanted chemicals, that even in small amounts may influence the efficacy and safety of the pharmaceutical products. 5.

What is impurity profiling in pharmacology?

A description of the identified and unidentified impurities present in a new drug substance [2]. Drug impurity profiling, i.e. identification, structure elucidation and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulations [3].

What are the components of impurities?

1. CONTENTS INTRODUCTION SOURCES OF IMPURITIES TYPES OF IMPURITIES SOURCES OF ORGANIC IMPURITIES GENOTOXIC IMPURITIES REFERENCES 2 2. IMPURITIES? Impurities are chemical substances composed of liquid, gas, or solid, which differ from the chemical composition of the material or compound.

How do you identify impurities in a drug?

There are different methods for detecting and characterizing impurities with TLC, HPLC, and HPTLC etc. The most exploited techniques, for impurity profiling of drugs are LC-MS-MS, LC-NMR, LCNMR- MS, GC-MS, and LC-MS.