Substances Intended for Storage in a Refrigerator

If significant change occurs between 3 and 6 months testing at the accelerated storage condition, the proposed retest period should be based on the real-time data available at the long-term storage condition (Table 2.2). If 

Minimum Time Period Covered by Data at Submission (months) 

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Table 5 Storage and Minimum Time Covered for Drug Substances Intended for Storage in a Refrigerator...

Table 8.5 Storage and minimum time covered for drug substances intended for storage in a refrigerator.

Drug substances and products intended for storage in a refrigerator Long term storage condition at 5 3°C for 12 months. 

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