Pharmaceuticals/stabilty of API

Advertisement


Question
QUESTION: 1.For an API can i assign 72 months shelf life if i am having 60 months real time stabilty data ?

2.i had a old API material of 2008 in which  retest date is due on  APR 2013.(5 years completed). Can i repeat one purification or reprocess it and can i extend 5 more years of retest period up to APR 2018  With statical analysis

ANSWER: 1.For an API can i assign 72 months shelf life if i am having 60 months real time stabilty data ?

NO - UNLESS YOU HAVE 3 YEARS ACCELERATED DATA, AND COMMIT TO ON-GOING ROOM TEMPERATURE STUDIES TO CONFIRM THE ACCELERATE DATA IN WHICH CASE OK.

2.i had a old API material of 2008 in which  retest date is due on  APR 2013.(5 years completed). Can i repeat one purification or reprocess it and can i extend 5 more years of retest period up to APR 2018  With statistical analysis

YES AS LONG AS THE RECRYSTALLIZED MATERIAL MEETS YOUR ORIGIAL FULL API STECIFICATION.

---------- FOLLOW-UP ----------

QUESTION: thanks for your answer.any guidelines for establishing  a new retest date for an old api which its old retest date of 5 years completed. How many years retest period we can give for a api maximum

Answer
The maximum retest date you can assign to an API entirely depends on the length of time you can perform your stability study.

If you want a 10-year retest date, then keep your stability study going for 10 years (the need the 10 years of data before you can claim the 10-year re-test dating)

Pharmaceuticals

All Answers


Answers by Expert:


Ask Experts

Volunteer


Michael Anisfeld

Expertise

Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

Experience


Past/Present Clients
UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries

©2016 About.com. All rights reserved.