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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.
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.
Translation Support
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.
| STUDY | CONDITIONS | STUDY PERIOD | APPLICATION | GUIDELINES |
|---|---|---|---|---|
| Long Term | 25° C ± 2° C / 60% RH ± 5% RH 30° C ± 2° C / 65% RH ± 5% RH 30° C ± 2° C / 75% RH ± 5% RH | 12 months | General Conditions | ICH Q1 A (R2) |
| Accelerated | 40° C ± 2° C / 75% RH ± 5% RH | 06 months | Drug Products packed in Semi-permeable containers | |
| Long Term | 25° C ± 2° C / 40% RH ± 5% RH 30° C ± 2° C / 35% RH ± 5% RH | 12 months | ||
| Intermediate | 30° C ± 2° C / 65% RH ± 5% RH | 06 months | ||
| Accelerated | 40° C ± 2° C / NMT 25% RH | 06 months | Drug products for storage in Refrigerator | |
| Long Term | 5° C ± 3° C | 12 months | ||
| Accelerated | 25° C ± 2° C / 60% RH ± 5% RH | 06 months | Drug products intended for storage in a Freezer | |
| Long Term | -20° C ± 5° C | 12 months | ||
| Photostability | Exposure to Light intensity of 1.2 million Lux Hours & UV Light intensity of 200 watt / sq. mtr. | ICH Q1 B | ||
| Other Conditions | + 50° C / Ambient RH 60° C ± 2° C / 75% RH ± 5% RH |