Method Validation : A Part from The Book Chapter : Analytical Method Validation Parameters (USP/ICH)

The process of confirming through laboratory testing that an analytical procedure’s performance characteristics match the demands for the planned analytical applications is known as validation. Method validation, sometimes known as “the process for providing documented evidence that the method does what it is intended to do,” offers a guarantee of reliability during regular use. The primary goal of the validation process is to show that the analytical method is accurate, specific, and precise within the designated range for the analyte being tested, and that it is appropriate for the intended use. Analytical Approach Validation must be carried out for both new and existing analysis methods whenever modifications are made to the process or the medication product’s composition. Common types of analytical procedure that can be validated.

Author(s) Details:

V. Siddaiah,
Department of Chemistry, Andhra University, Visakhapatnam-530003, India.

To Read the Complete Chapter See Here

Related Posts

Herbal Plant

The Herbal Plant is Not Only used as an Anticoagulant : A Part from The Book Chapter : Phytochemical and Antimicrobial Study of Crude Extracts of Herbal Potentilla reptans L.

The herbal plant is not only used as an anticoagulant, antiseptic, depurative, and febrifuge but it is also employed in decoction and the fresh leaves by crushing…

Fish

Fish Protein Hydrolysate : A Part from The Book Chapter : Hydrolysate Protein Production from Catfish with Understanding of the Potential Antioxidant Activity

Harnessing proteins from less valued fish species holds the potential to enhance the functional value of the resulting products. As highlighted by Chalamaiah et al., the production…

Tumor Aggressiveness

Kallikrein Proteins are Mysteriously Expressed in Several forms of Cancer : A Part from The Book Chapter : An In-silico Study of Pathological Angiogenesis; Design of Anticancer Agent Inhibiting KLK – 12

Kallikrein proteins are mysteriously expressed in several forms of cancer. Additionlly, Kallikrein-related peptidase 6 (KLK6) overexpression is commonly observed in primary tumors of colorectal cancer (CRC) patients…

Ir(III)

The Necessary Instruments are Expensive, Day to Day Maintenance Costs are High : A Part from The Book Chapter : Kinetic Spectrophotometric Method for the Determination of Ir(III) in Microgram on the Oxidation of Alanine by HCF(III) in Aqueous Alkaline Medium

The necessary instruments are expensive, day to day maintenance costs are high and the methods are not free from various types of interferences. Some researchers also reported…

Chemical Oxidation

Photo Catalytic Degradation Using Nanosized TiO2 : A Part from The Book Chapter : Micellar Effects of Cetyl Trimethyl Ammonium Bromide (CTAB) and Sodium Dodecyl Sulphate (SDS) on Oxidation of Indigo Carmine with Potassium Peroxy Diphosphate

Several methods were followed in removal of this dye like adsorption method using Citrus reticulata treated with formaldehyde and urea, degradation using Nano crystalline cadmium sulphide films…

Natural bioactive

Phenolic Acids: A Part from The Book Chapter: A Comprehensive Analysis of the Medicinal Use of Bioactive Secondary Metabolites from the Genus Ehretia

Natural bioactive substances like secondary metabolites and antioxidants may be found in plants. The therapeutic agent and secondary metabolite found in medicinal plants are phenolic acids. Fruits…

Leave a Reply