IMPURITY PROFILE: - STUDY A BETTER WAY FOR QUALITY CONTROL OF PHARMACEUTICALS PRODUCTS
*Ramchandra Gupta2, Prabhakar Sharma2, Prakash Pandey2, Pratik Jain1, Ajay Shukla3
1Department of Pharmacognosy,
2Department of Pharmaceutics,
3Department of Pharmaceutical Chemistry
1,2,3Guru Ramdas Khalsa Institute of Science and Technology (Pharmacy) Jabalpur, 483001, M.P.
In the pharmaceutical world, an impurity is considered as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted chemicals that remains with API’s. Pharmaceuticals impurities are the unwanted chemicals that remain or are generated during the formulation of medicines. The presence and quantity of impurities in pharmaceutical drugs can have a significant impact on their quality and safety, with the continuous pressure for increased industry productivity, there is urgent need for a systematic and comprehensive drug impurity profiling strategy. The impurities present in the drug are adversely affecting the quality of the drug product. There are various types of impurities like starting materials, intermediates, penultimate impurity, by product and degradation product. Impurity profiling helps in detection, identification and quantification of various types of impurities as well as residual solvents in bulk drugs and in pharmaceutical formulations. It is a best way to characterize quality and stability of bulk drugs and pharmaceutical formulations. This review paper deals with the impurity profile of pharmaceuticals.
REFERENCE ID: PHARMATUTOR-ART-1783
Impurity is something that impure or makes something else impure. An impure substance may be defined as a substance of interest mixed or impregnated with an extraneous or usually inferior substance[1-3]. During the production of active pharmaceutical ingredients (API), many opportunities for the generation of impurities may arise. Dictionary meaning of impurity is something that is impure or makes another thing impure. So, impurity in short way can be defined as, any material that affects the purity of the material of interest, i.e. an active pharmaceutical ingredient (API) or drug substance, it can also be defined as ‘any substance coexisting with the original drug substance, such as starting material or intermediates from reaction or that is formed, due to any chemical interaction or by products from side reaction’. The safety of the drug depends not only on the toxicological properties of the API itself, but on the impurities it contains. For this reason, accurate assessment of impurity profiles of API is one of the most important fields of activity in pharmaceutical analysis. In the meanwhile, any changes in the synthetic process, such as synthetic routes, reaction conditions, purification processes, etc. which are common as a drug candidate goes through various development stages and process scale up, may lead to changes in the impurity profile and in questions about safety. Hence, the impurity profiling becomes a frequent task, which often time-consuming and labor-intensive.
Impurity profiling is a group of analytical activities, with the aim of detection, identification/structure elucidation and quantitative determination of organic and inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. Various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredient’s (API’s). The description, characterization and quantization of the identified and unidentified impurities present in new drug substances are known as impurity profile. It gives an account of impurities present in the bulk and finished drug. It helps in identifying and quantifying the impurities present in drug substance (API) or pharmaceutical formulation. It gives maximum possible types of impurities present in drug substance (API) and in pharmaceutical formulations.
CLASSIFICATION OF IMPURITIES
Pharmaceuticals can be divided in to two major areas active pharmaceutical ingredients (APIs) which is also referred as drug substance (DS) and drug product (DP) which is also called as finished pharmaceutical product (FPP). The Impurities of pharmaceuticals are classified on the basis of pharmacopeia and ICH guidelines.
A. Common names
B. United State Pharmacopeia
The United States Pharmacopoeia (USP) classifies impurities in various sections;
Impurities in Official Articles
Organic Volatile Impurities
C. ICH Terminology
According to ICH guidelines, impurities in the drug substance produced by chemical synthesis can broadly be classified into following three categories;
Organic Impurities (Process and Drug related)
Organic impurities may arise during the manufacturing process and or storage of the drug substance may be identified or unidentified, volatile or non-volatile, and may include;
Starting materials or intermediates
SOURCES OF IMPURITIES
There are various sources of impurities in any pharmaceutical drug and dosage form from the beginning of product to its finishing. There are 2 types of impurities in medicines: (1) Impurities associated in with active pharmaceutical ingredients and (2) Impurities that form are created during formulation and or with aging or that are related to the formulated forms. In general, the various types of impurities that may be present in pharmaceutical substances can come from the following sources:
1. The raw materials used.
2. The method of manufacture adopted.
3. Due to the instability of product and
4. from the atmospheric contaminants.
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