Applications

WHY STABILITY STUDIES?

  • The primary reason for stability testing is the concern for the well-being of the patient suffering from the disease for which the products are being designed.
  • Degradation of the unstable product into toxic decomposition products not only results in loss of product activity but may lead to failure of the therapy resulting in death.
  • It has become a legal requirement to provide data for stability tests for the regulatory agencies before launching a new product commercially.
  • Stability studies protect the reputation of manufacturer by assuring that the product will retain its fitness for use with respect to quality as long as it is in market.
  • Other benefits of stability studies at developmental stage or marketed products are to provide database that may be of value in selection of adequate formulations, excipients and container closure system for development of new products.

The ideal choice is NEWTRONIC Chambers...

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Application

Successful Stability Studies have become a must criteria to meet the regulatory requirements of the various international bodies such as ICH, FDA, TAPPI, TGA, JPMMA, MHRA, ANVISA, ASEAN or any of the National Testing Standards.

 

Study

Long Term


Accelerated
Long Term

Intermediate*
Accelerated
Long Term
Accelerated
Long Term
Photostability
Other Conditions

Conditions

25° C ± 2° C / 60% RH ± 5% RH
30° C ± 2° C / 65% RH ± 5% RH
30° C ± 2° C / 75% RH ± 5% RH
40° C ± 2° C / 75% RH ± 5% RH
25° C ± 2° C / 40% RH ± 5% RH
30° C ± 2° C / 35% RH ± 5% RH
30° C ± 2° C / 65% RH ± 5% RH
40° C ± 2° C / NMT 25% RH
5° C ± 3° C
25° C ± 2° C / 60% RH ± 5% RH
-20° C ± 5° C
Exposure to Light intensity of 1.2 million Lux Hours & UV Light intensity of 200 watt / sq. mtr.
+ 50° C / Ambient RH 60° C ± 2° C / 75% RH ± 5% RH

Study Period

12 months


06 months
12 months

06 months
06 months
12 months
06 months
12 months
 
 

Application

General Conditions
Drug Products packed in Semi-permeable containers
Drug products for storage in Refrigerator
Drug products intended for storage in a Freezer
 
 

Guidelines

 
* If 30°C / 35% RH is the long -term, there is no intermediate