SOURCES OF IMPURITIES: A REVIEW
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 1
Abstract
Impurity is defined as an entity of drug substance or drug product that is not chemical entity defined as drug substance, an excipient, or other additives to drug products. In Webster’s dictionary, impurity is “something that is impure or makes something else impure. In the pharmaceutical world, an impurity is generally considered as any other organic material besides the drug substance that arises out of the synthesis most of the time; inorganic contaminants are not considered as impurities unless they are toxic, such as heavy metals or arsenic. There are numerous sources of impurities and many different common terms are used for impurities such as Intermediates, Penultimate intermediates, Byproducts, Transformation products, Interaction products, related products and Degradation products. In this review, a description of different types of impurities in relation to ICH guidelines including specific examples, are presented.
Authors and Affiliations
Ashu Sapra , Saloni Kakkar , Narasimhan B.
Keywords
Related Articles
- EP ID EP86504
- DOI -
- Views 121
- Downloads 0
MACROSCOPIC AND MICROSCOPIC CHARACTERIZATION OF THE AERIAL PARTS OF TRIBULUS ALATUS (ZYGOPHYLLACEAE) GROWING IN EGYPT
Tribulus alatus is a promising medicinal plant. Macroscopic and microscopic studies were carried out on leaflet, rachis, stem and fruit as well as powdered aerial parts. Powder microscopy revealed the presence of anomocy...
ANTIULCER AND ANTI-INFLAMMATORY ACTIVITY OF CAJANUS CAJAN LINN.
Cajanus cajan Linn. is commonly used in Indian folk medicine to treat various ulcers and inflammatory conditions. Different extracts of the leaves was prepared with petroleum ether, ethyl acetate, ethanol and water. Each...
PHARMACOGNOSTIC, PHYTOCHEMICAL AND PHYSICOCHEMICAL STUDIES OF PIPER NIGRUM LINN. FRUIT (PIPERACEAE)
Piper species are reported to have great medicinal value in Indian medicine. Fruits of Piper nigrum Linn is commonly known as “Kalimiri” belongs to the family of Piperaceae and widely used as a pungent condiment. Traditi...
ELASTIC LIPOSOME: DRUG DELIVERY ACROSS HUMAN SKIN
Transdermal drug delivery is hardly an old technology, since 1800’s and the technology is no longer just adhesive patches. Due to recent advances in technology and the ability to apply the drug to the site of action with...
SYNTHESIS AND ANTIMICROBIAL ACTIVITY OF TRIAZINOINDOLES
Several new 3,4-dihydro-4-oxo-1,2,4-triazino(4,5-a) indoles (3a-g) were synthesized string from ethyl substituted indole-2-carboxylates (1a-g) which were allowed to react with hydrazine hydrate (80%) in ethanol to furnis...