Expired date of test reagents

GOOD LABORATORY PRACTICE (cGLP)
1

Dear Sirs,
Please help me with the question.
I am wondering how to establish the expired date for the test reagents (using for identification, test) that the expired date is not specified is pharmacopoeia.

Thank you very much!

2

Very simple,

usually we give 2 months expiry for reagents for identifiation tests.

Normalilty solutions- one month expiry.

Evaluation :

Examine a test sample by using freshly prepared solution and a solution prepared two months before.
Both the solutions should respond the same[Identification]. Document the same.

Normality solution : standardise the solution initially and after one month.

the variation of normality should not be away from +/-10%.

Regards,
Bujji Reddy Kanchi.
+91-9676749937

3
  1. Solutions used as reference standards for limit tests should be prepared immediately before use and discarded after use.
  2. Stock standard solutions may be kept up to 3 months in the fridge. The stock must be freshly diluted for each use.
  3. Volumetric solutions of Molarity less than 0.1M should be prepared immediately before use and then discarded after use.
  4. Volumetric solutions of greater than 0.1M should be re-standardized immediately before use.
  5. Standard stock solutions used in HPCL or GC analysis may be kept for a four weeks unless otherwise stated in the control method, after which they should be discarded.
  6. Generally an expiry of 6 months is acceptable for all solutions of reagents or indicators unless otherwise stated.
    Dr.Pradeep Nagalkar