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Area of Appplications

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Pharmacuticals

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Application Related Products

Cosmetics

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Application Related Products

Food

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Application Related Products

Blood Bank

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Green House

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Application Related Products

Biotech

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Reserch & Development

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Warehouse

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Application Related Products

WHY STABILITY STUDIES?

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.

APPLICATION

  • 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.

Stability Guidelines

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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