It is becoming famous in some pharmaceutical industry that a raw material that is to be expired some few days maybe when discovered will be used for production of new drugs and the new drug will still be given an expiration date of 4 years.
Yes most times the potency of the drug is still 95 or 100%.
Yes. You can use the API few days before to formulate your finished dosage form as long as you guarantee the stability of your finished dosage form till its shelf life.
No , You can not use for Regulatory markets until unless u have no further stability data.
many pharmaceutical industry have own policy for assurance their products... I hear today...many industry apply risk management to set daily activity like quality control, production activity, etc..
You should have it retested to confirm it will last until at least the end of the finished product expiry period
You can assess the expiration using TGA/DSC technique. More over, the level of limit of other materials mentioned in the official monograph is required to be determined for safe use of the API
It is wrong,technically and ethically.You should not until you have tested it and found it to be of acceptable quality.Raw materials must be of acceptable quality.
API or excipient can be used depending on the stability studies. But few excipient like preservatives and anti oxidants are not preferred beyond their shelf life.
Secondly it is not preferable to use any raw material nearing it's expiry date.
Firstly, you have to ensure your Active Pharmaceutical Ingredient are still in the assay requirements range... for some raw materials that past it's expired date, you have to re-test it...
If the assay is still in range (see the monograph instead the references such as USP/BP/EP) you may use that raw materials for production/manufacturing process...
As far as I suggest is that you do not use the raw materials ewhich are going to be expired soon . We don't know shelf life and then it is unethical to use for any purpose. It is like providing something with a known and increased risk which we all avoid.
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