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Requirements for dissolved oxygen and/or head space oxygen in Pharmaceuticals

ChemistAnalytical

Starting to get Involved
#1
In the pharmaceutical world are there drug product monographs that test for dissolved oxygen or head space oxygen? I'm asking because I know oxygen affects stability for some drug products. Therefore, I am purchasing instruments to test oxygen in drug products (vials and ampules). However, I'm not sure the appropriate range I should target.

I'm struggling to find guidance in USP or FDA.

Dissolved oxygen meters appear to operate from trace oxygen (~0.05 ppm) to 50 ppm oxygen. Would this be adequate? Head space analyzers vary. Some are 150 ppm to 25000 ppm oxygen while others are not as sensitive.

Thanks,
 

ChemistAnalytical

Starting to get Involved
#3
Hi Marc, and thanks for the bump.

I have since discovered more about this topic. I have not found monographs that control oxygen, yet. However, typical dissolved oxygen in water is around 8 ppm. With nitrogen sparge, I am able to diminish oxygen down to 2 ppm (and slowly improving on this number) using a dissolved oxygen meter which uses partial pressure. Based on this information I find that the dissolved oxygen meter is adequate.

It is my opinion that a head space analyzer is not necessary. Henry's Law states that the head space gas concentration is proportional to the dissolved concentration. Concerns about differences between head space and dissolved oxygen concentration should be resolved by vortexing samples to allow head space and dissolved oxygen levels to reach equilibrium.

The dissolved oxygen analyzers appear to be adequately accurate and precise and also far less expensive than head space analyzers.

Now my challenge is approaching 0 ppm dissolved oxygen. I think shrinking the size of the nitrogen bubbles during sparge will help.
 
#4
I have a challenge in soft gelatin capsule production area; the area is class C till blistering and class D in packaging room so can I physically separate the area that includes blistering and packaging rooms to avoid production of hazardous soft gelatin products in campaign where the blistering stage is the bottle neck of production time ???
what should I maintain to allow production of 2 different soft gelatin products ( one of them is hazard) at the same time ?
 
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