A Review on Stability Guidelines by ICH and USFDA Guidelines for New Formulation and Dosage form

AUG 2014 ARTICLE LIST >>

PharmaTutor (August- 2014)
ISSN: 2347 - 7881
(Volume 2, Issue 8)

Received On: 03/05/2014; Accepted On: 01/06/2014; Published On: 01/08/2014

AUTHORS: Anilkumar S. Chinchole¹*, B.N.Poul², C.V. Panchal¹, D.V. Chavan^1
1Department of Quality Assurance, Maharashtra College of Pharmacy, Nilanga, Latur, Maharashtra, India
²Principal of Maharashtra College of Pharmacy, Nilanga
Maharashtra College of Pharmacy, Nilanga, Latur, Maharashtra, India
*anilc14@gmail.com

ABSTRACT:
Stability guidelines for new drug substance and new pharmaceutical formulations as per ICH and USP for the evaluation and consistency for new drug and pharmaceutical dosage form. The brief understanding of these guidelines can be easily recognized by this article. Stability testing Provide a evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. To establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions. Because physical, chemical or microbiological changes might impact the efficiency and security of the final product. To minimize the Adverse Effects Of Instability In Drug Products Loss of potency of drug such as Change in concentration of active drug, Alteration of bioavailability, Loss of content uniformity, Loss of pharmaceutical elegance and patient acceptability, Formation of toxic degradation products.

How to cite this article: AS Chinchole, B Poul, CV Panchal, DV Chavan; A Review on Stability Guidelines by ICH and USFDA Guidelines for New Formulation and Dosage form; PharmaTutor; 2014; 2(8); 32-53

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