Publication Type: Edited Book
BRIEF REVIEW OF STABILITY STUDY- A RECENT TREND OF AYURVEDIC PHARMA INDUSTRY W.S.R. TO ACCECLERATED STABILITY STUDY OF KVGAP’S HAEMOCARE SYRUP
Book Name: Futuristic Trends in Medical Sciences Volume 3 Book 22
Authors: K Shruthan, K G Purushotham, Nayak N Gopalakrishna, M Harshitha, K B Pavana
Keywords: Ayurvedic Pharma Industry, Haemocare Syrup, Organoleptic Parameters,
Area/Stream: Medical, Pharmaceutical & Nursing Sciences / Management in Health Care / Others
Published in: IIP Series
Volume: 3, Month:May,Year:2024
Page No.: 166-179
e-ISBN: 978-93-6252-449-2
DOI/Link: https://www.doi.org/10.58532/V3BDMS22P4CH3
Abstract:
Stability studies are new quality control paradigms which ensure better safety, quality and efficacy of proprietary medicines throughout their shelf life under controlled storage conditions of temperature and humidity. Accelerated stability testing of an ayurvedic proprietary medicine: KVGAP’S Haemocare syrup was done as per guidelines of Ayurvedic Pharmacopeia of India. KVGAP’S Haemocare Syrup were manufactured in 3 pilot batches, packed in the container and closure system proposed for marketing and stored at elevated stress conditions (Temperature 40 ± 2 °C, Relative humidity 75 ± 5 %.) The reference samples were stored at a temperature of less than 10 0c. Samples were evaluated at the intervals of 0, 3 and 6 months for organoleptic parameters, Physico-chemical Parameters, TLC, Microbial analysis and test for specific pathogens. On analysis, samples did not showed differences from the initial values of physico chemical parameters beyond the specified limits (25 percent), Neither new spots were seen in TLC plates, nor did the existing spots disappear. The product’s appearance, taste, odor and color remained unchanged throughout the study period. No growth of microbes were detected and specific micro-organisms were absent in the samples throughout the study period. Hence the product remains stable in accelerated storage conditions. Shelf life of the Haemocare syrup was estimated to be 4.18 years if stored in accelerated stress conditions. This study can provide valuable information to design stability studies of ayurvedic formulations.
Cite this: K Shruthan, K G Purushotham, Nayak N Gopalakrishna, M Harshitha, K B Pavana,"BRIEF REVIEW OF STABILITY STUDY- A RECENT TREND OF AYURVEDIC PHARMA INDUSTRY W.S.R. TO ACCECLERATED STABILITY STUDY OF KVGAP’S HAEMOCARE SYRUP ", Futuristic Trends in Medical Sciences Volume 3 Book 22,IIP Series, Volume 3, May, 2024, Page no.166-179, e-ISBN: 978-93-6252-449-2, DOI/Link: https://www.doi.org/10.58532/V3BDMS22P4CH3
