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Subject:
From:
Michael Barton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 16 Oct 2019 19:31:11 +0000
Content-Type:
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text/plain (311 lines)
Thanks Tim,

where it says ''For materials used as active substances'' what does this actually mean?
Is this just saying a finished product with the  API in the bulk material being less than 1000g

how is the 10% for 1500 units defined? This would be 7.5g in my scenario is that ok or expeceted to go to required 10g

thanks again for your help
Mike
________________________________
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Timothy Cser <[log in to unmask]>
Sent: 16 October 2019 14:58
To: [log in to unmask] <[log in to unmask]>
Subject: Re: [PMFLIST] <61> defining amount to be tested.

Hi Mike.  You would need to take 10% of a 1500 unit batch.  In your previous example you could take 1% of your 1000 units for a total of 0.5g (1%).

This is directly from USP 61:

"For materials used as active substances where the sample quantity is limited or batch size is extremely small (i.e., less than 1000 mL or 1000 g), the amount tested shall be 1% the batch unless a lesser amount is prescribed or justified.  For products where the total number of entities in a batch is less than 200 (e.g., samples used in clinical trials), the sample size may be reduced to two units, or one unit if the size is less than 100.  Select the sample(s) at random from the bulk material or from the available containers of the preparation. To obtain the required quantity, mix the contents of a sufficient number of containers to provide the sample."

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Michael Barton
Sent: Tuesday, October 15, 2019 11:13 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] <61> defining amount to be tested.

Thanks All,
if the batch size was 1500 units what would be the expectation?

Tim Cser, would you be able to provide example on the provision for small active ingredient detail and how it can be used.

If it is a single dose unit, is there a possibility of testing 10 units (like it allows for MDI) and applying the spec against per unit as this is what a patient would be exposed to?

thanks
Mike
________________________________
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of Kerri Sturtevant <[log in to unmask]>
Sent: 11 October 2019 19:14
To: [log in to unmask] <[log in to unmask]>
Subject: Re: [PMFLIST] <61> defining amount to be tested.

USP<61> states that for materials where sample quantity is limited or batch size is extremely small (less than 1000mL or 1000g), test 1% of the batch.

*Kerri Sturtevant*




On Fri, Oct 11, 2019 at 8:44 AM Michael Barton <[log in to unmask]>
wrote:

> Hi All,
> is anyone able to help me with this query. thanks
>
> If a single use product (non-sterile powder) is 50mg with active part
> 2mg and the product was extremely expensive and only manufactured in
> 1000units per batch (50g) are you expected to pool together 200units
> in order to obtain 10g to be tested.
>
> This seems impractical taking a lot of the batch and potentially at a
> very high cost.
>
> ________________________________
> From: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]> on behalf of Michael Barton <
> [log in to unmask]>
> Sent: 27 September 2019 07:27
> To: [log in to unmask] <
> [log in to unmask]>
> Subject: [PMFLIST] <61> defining amount to be tested.
>
> Hello all,
>
> If a single use product (non-sterile powder) is 50mg with active part
> 2mg and the product was extremely expensive and only manufactured in
> 1000units per batch (50g) are you expected to pool together 200units
> in order to obtain 10g to be tested.
>
> This seems impractical taking a lot of the batch and potentially at a
> very high cost.
>
> Thanks Mike
>
>
> ------------------
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> https://clicktime.symantec.com/3De41Xeg1aD7vDxNXxQuSPf6H2?u=http%3A%2F
> %2Fwww.sterislifesciences.com%2F
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> Charles River Laboratories -
> https://clicktime.symantec.com/3Hrcv2xf23nJTyHUrbmBZ456H2?u=http%3A%2F
> %2Fwww.criver.com%2F
>
> Veltek Associates, Inc -
> https://clicktime.symantec.com/3G9N3xes5WqTM9bgn4cAiTX6H2?u=http%3A%2F
> %2Fwww.sterile.com
>
> Microbiologics, Inc. -
> https://clicktime.symantec.com/3HWiYiK8VJJJihJ64wJB5ED6H2?u=http%3A%2F
> %2Fwww.microbiologics.com
>
> BD Industrial Media -
> https://clicktime.symantec.com/3hLoPAewP1yJVtH4SBBQGz6H2?u=http%3A%2F%
> 2Fwww.bd.com%2Fds%2F
>
> Boston Analytical
> https://clicktime.symantec.com/3QK9bobKjBTjvr28Btmt6hZ6H2?u=http%3A%2F
> %2Fwww.bostonanalytical.com%2F
>
> Associates of Cape Cod, Inc. -
> https://clicktime.symantec.com/3QBnje6y7168MQK7GTKboSh6H2?u=http%3A%2F
> %2Fwww.acciusa.com%2F
>
>
> =================================
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> ------------------
> The PMFList
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> F%2Fmicrobiologynetwork.com%2Fpmflist.asp) is operated from The Microbiology Network (https://clicktime.symantec.com/3FnHvcHf9cakDuEXzmBRbvx6H2?u=http%3A%2F%2Fmicrobiologynetwork.com) and supported by our sponsors as a service to the scientific community.
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> https://clicktime.symantec.com/3De41Xeg1aD7vDxNXxQuSPf6H2?u=http%3A%2F
> %2Fwww.sterislifesciences.com%2F
>
> Charles River Laboratories -
> https://clicktime.symantec.com/3Hrcv2xf23nJTyHUrbmBZ456H2?u=http%3A%2F
> %2Fwww.criver.com%2F
>
> Veltek Associates, Inc -
> https://clicktime.symantec.com/3G9N3xes5WqTM9bgn4cAiTX6H2?u=http%3A%2F
> %2Fwww.sterile.com
>
> Microbiologics, Inc. -
> https://clicktime.symantec.com/3HWiYiK8VJJJihJ64wJB5ED6H2?u=http%3A%2F
> %2Fwww.microbiologics.com
>
> BD Industrial Media -
> https://clicktime.symantec.com/3hLoPAewP1yJVtH4SBBQGz6H2?u=http%3A%2F%
> 2Fwww.bd.com%2Fds%2F
>
> Boston Analytical
> https://clicktime.symantec.com/3QK9bobKjBTjvr28Btmt6hZ6H2?u=http%3A%2F
> %2Fwww.bostonanalytical.com%2F
>
> Associates of Cape Cod, Inc. -
> https://clicktime.symantec.com/3QBnje6y7168MQK7GTKboSh6H2?u=http%3A%2F
> %2Fwww.acciusa.com%2F
>
>
> =================================
> The nature of this service is to provide a medium for communication.
> The specific statements and endorsements of individuals participating
> in the discussions are not necessarily those of The Microbiology
> Network, Inc., the PMF, or the sponsors of the list.
>

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Steris - https://clicktime.symantec.com/3De41Xeg1aD7vDxNXxQuSPf6H2?u=http%3A%2F%2Fwww.sterislifesciences.com%2F

Charles River Laboratories - https://clicktime.symantec.com/3Hrcv2xf23nJTyHUrbmBZ456H2?u=http%3A%2F%2Fwww.criver.com%2F

Veltek Associates, Inc - https://clicktime.symantec.com/3G9N3xes5WqTM9bgn4cAiTX6H2?u=http%3A%2F%2Fwww.sterile.com

Microbiologics, Inc. - https://clicktime.symantec.com/3HWiYiK8VJJJihJ64wJB5ED6H2?u=http%3A%2F%2Fwww.microbiologics.com

BD Industrial Media - https://clicktime.symantec.com/3hLoPAewP1yJVtH4SBBQGz6H2?u=http%3A%2F%2Fwww.bd.com%2Fds%2F

Boston Analytical https://clicktime.symantec.com/3QK9bobKjBTjvr28Btmt6hZ6H2?u=http%3A%2F%2Fwww.bostonanalytical.com%2F

Associates of Cape Cod, Inc. - https://clicktime.symantec.com/3QBnje6y7168MQK7GTKboSh6H2?u=http%3A%2F%2Fwww.acciusa.com%2F


=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

------------------
The PMFList (https://clicktime.symantec.com/3B2UZJoTw8FaSjzYvg4uPSw6H2?u=http%3A%2F%2Fmicrobiologynetwork.com%2Fpmflist.asp) is operated from The Microbiology Network (https://clicktime.symantec.com/3FnHvcHf9cakDuEXzmBRbvx6H2?u=http%3A%2F%2Fmicrobiologynetwork.com) and supported by our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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Science Advisory Board https://clicktime.symantec.com/34mF8CSCUvLFqsvZrbLYY4m6H2?u=https%3A%2F%2Fwww.scienceboard.net%2F

Steris - https://clicktime.symantec.com/3De41Xeg1aD7vDxNXxQuSPf6H2?u=http%3A%2F%2Fwww.sterislifesciences.com%2F

Charles River Laboratories - https://clicktime.symantec.com/3Hrcv2xf23nJTyHUrbmBZ456H2?u=http%3A%2F%2Fwww.criver.com%2F

Veltek Associates, Inc - https://clicktime.symantec.com/3G9N3xes5WqTM9bgn4cAiTX6H2?u=http%3A%2F%2Fwww.sterile.com

Microbiologics, Inc. - https://clicktime.symantec.com/3HWiYiK8VJJJihJ64wJB5ED6H2?u=http%3A%2F%2Fwww.microbiologics.com

BD Industrial Media - https://clicktime.symantec.com/3hLoPAewP1yJVtH4SBBQGz6H2?u=http%3A%2F%2Fwww.bd.com%2Fds%2F

Boston Analytical https://clicktime.symantec.com/3QK9bobKjBTjvr28Btmt6hZ6H2?u=http%3A%2F%2Fwww.bostonanalytical.com%2F

Associates of Cape Cod, Inc. - https://clicktime.symantec.com/3QBnje6y7168MQK7GTKboSh6H2?u=http%3A%2F%2Fwww.acciusa.com%2F


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The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Science Advisory Board https://www.scienceboard.net/

Steris - http://www.sterislifesciences.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Science Advisory Board https://www.scienceboard.net/

Steris - http://www.sterislifesciences.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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