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Setting Specification Limits for UOD (Uniformity) for Live Bacteria or Spores

v9991

Trusted Information Resource
#1
eg., a label claim of 1-billion count
* can we go for 85%-115% of specification for UOD
* in what cases we need to go for specification of NLT 100% count

now considering , contents could be
the whole content constitutes the live cells + other excipients
OR
it could be total fill weight delivering to total assay
 
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Marc

Fully vaccinated are you?
Staff member
Admin
#2
Re: How to set the Specification Limits for UOD (Uniformity) for Live Bacteria or Spo

For those of us following along:

NLT = ?
UOD = ?
 

v9991

Trusted Information Resource
#3
Re: How to set the Specification Limits for UOD (Uniformity) for Live Bacteria or Spo

NLT :- not less than
UOD :- Uniformity of dosage units.
 

Ajit Basrur

Staff member
Admin
#4
eg., a label claim of 1-billion count
* can we go for 85%-115% of specification for
* in what cases we need to go for specification of NLT 100% count

now considering , contents could be
the whole content constitutes the live cells + other excipients
OR
it could be total fill weight delivering to total assay
Could you tell more about the product and are you trying to accomplish the Total Bacterial Count through this exercise ?
 

v9991

Trusted Information Resource
#5
No, i am not talking about microbial counts. (they are limit tests, not assays/UODs)

The product i am referring is like an probiotics containing live spores/cells.
 
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