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Offline pankajcops

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Regarding potency calculation
« on: February 14, 2008, 10:53:08 PM »
Hi,
I have one question. We are using Esomeprazole magnesium dihydrate as working standard for analysis of Esomeprazole. The potency of that standard is 94.23 on as is basis . So in calculation we should use Esomeprazole magnesium dihydrate or Esomeprazole magnesium .Can anyone help me in this ?

Offline JGK

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Re: Regarding potency calculation
« Reply #1 on: February 26, 2008, 12:21:55 PM »
I'm getting a strange sense of Deja vu.

I beleive that using the "as is" potency will give you the Esomeprazole magnesium concentration.  "As is" potenct will account for water content and other impurities.

If you want to calculate Esomeprazole content you should adjust based on the % Esomeprazole  in Esomeprazole magnesium (from MW data).
Experience is something you don't get until just after you need it.

Offline nauticar

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Re: Regarding potency calculation
« Reply #2 on: February 26, 2008, 11:45:42 PM »
In your analysis of Esomeprazole, is the sample analyzed based on as-is or dried?

It pretty much depends on the nature of your sample. If it's hygroscopic, your results (Im assuming youre calculating assay here) might not be as accurate as they should be.

N

Offline pankajcops

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Re: Regarding potency calculation
« Reply #3 on: February 27, 2008, 05:34:32 AM »
I'm getting a strange sense of Deja vu.

I beleive that using the "as is" potency will give you the Esomeprazole magnesium concentration.  "As is" potenct will account for water content and other impurities.

If you want to calculate Esomeprazole content you should adjust based on the % Esomeprazole  in Esomeprazole magnesium (from MW data).
.
If on "as is" basis we have to adjust based on the % Esomeprazole  in Esomeprazole magnesium (from MW data), then what we should do on dried basis. How we can calculate the Esomeprazole content. In that also we have to adjust based on the % Esomeprazole  in Esomeprazole magnesium (from MW data) or something else.Please give reply.

Offline JGK

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Re: Regarding potency calculation
« Reply #4 on: February 27, 2008, 08:19:46 AM »
I'm getting a strange sense of Deja vu.

I beleive that using the "as is" potency will give you the Esomeprazole magnesium concentration.  "As is" potenct will account for water content and other impurities.

If you want to calculate Esomeprazole content you should adjust based on the % Esomeprazole  in Esomeprazole magnesium (from MW data).
.
If on "as is" basis we have to adjust based on the % Esomeprazole  in Esomeprazole magnesium (from MW data), then what we should do on dried basis. How we can calculate the Esomeprazole content. In that also we have to adjust based on the % Esomeprazole  in Esomeprazole magnesium (from MW data) or something else.Please give reply.


If you have Esomeprazole magnesium (dried) then all water has been removed. Does the certificate of analysis have a purity value (determined by HPLC or UV, etc.)?

To convert to Esomeprazole from Esomeprazole magnesium you need to apply that purity value (determined by HPLC or UV, etc.) then adjust based on the % Esomeprazole  in Esomeprazole magnesium (from MW data).

One question, if you have the Esomeprazole magnesium dihydrate and the potency on the "as is" basis, why do you dry the sample? It's not necessary and just seems to comlplicate a quite simple process.
Experience is something you don't get until just after you need it.

Offline pankajcops

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Re: Regarding potency calculation
« Reply #5 on: February 27, 2008, 11:46:25 PM »
I beleive that using the "as is" potency will give you the Esomeprazole magnesium concentration.  "As is" potenct will account for water content and other impurities.

If you want to calculate Esomeprazole content you should adjust based on the % Esomeprazole  in Esomeprazole magnesium (from MW data).

If you have Esomeprazole magnesium (dried) then all water has been removed. Does the certificate of analysis have a purity value (determined by HPLC or UV, etc.)?

To convert to Esomeprazole from Esomeprazole magnesium you need to apply that purity value (determined by HPLC or UV, etc.) then adjust based on the % Esomeprazole  in Esomeprazole magnesium (from MW data).

One question, if you have the Esomeprazole magnesium dihydrate and the potency on the "as is" basis, why do you dry the sample? It's not necessary and just seems to comlplicate a quite simple process.
[/quote]
Thanks for your reply. But as you have written that to convert to Esomeprazole from Esomeprazole magnesium you need to apply that purity value (determined by HPLC or UV, etc.) then adjust based on the % Esomeprazole  in Esomeprazole magnesium (from MW data).If its Esomeprazole magnesium  then we have to calculate the % of Esomeprazole in Esomeprazole magnesium. My question is if water is there means if its Esomeprazole magnesium dihydrate then in that case also you are telling to do the same thing.If I am not wrong you are telling to do the calculation on the basis of potency of Esomeprazole magnesium and Esomeprazole magnesium dihydrate.In both cases potency will be different then how we can calculate the % Esomeprazole in Esomeprazole magnesium  only because you have written to calulate Esomeprazole content based the % Esomeprazole  in Esomeprazole magnesium (from MW data).


Offline JGK

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Re: Regarding potency calculation
« Reply #6 on: February 28, 2008, 09:05:47 AM »
 I was not telling you to do the same thing twice, You presented two problems:

The first used a sample of Esomeprazole magnesium dihydrate;
The second used a sample of Esomeprazole magnesium dihydrate which had been dried (effectively removing the water content)

Let me try and clarify this once again:

For the first problem, you have Esomeprazole magnesium dihydrate and an "as is" potency value: When applied,this potecy will give you the Esomeprazole magnesium concentration as the "as is" potency will account for the water content and any impurities in the Esomeprazole magnesium.

From molecular weight data, you can calculate the percentage of Esomeprazole in  Esomeprazole magnesium.  Applying this value will enable you to calculate the amount of  "pure"  Esomeprazole in your
original Esomeprazole magnesium dihydrate sample.

In the second problen, you have taken Esomeprazole magnesium dihydrate which has been "dried"  (effectively removing the water content).this leaves you with Esomeprazole magnesium and any impurities in the material. In this case, the "as is" potency is of no use to you and you will now need to find a purity value for the Esomeprazole magnesium which does not include the water content. I would normally use a purity value (determined by HPLC or UV, etc.) which should be present on the certificate of analysis. Once this value is applied you have a "pure" Esomeprazole magnesium  concentration. From the mw data you can then caclulate "pure" Esomeprazole content in the sample.
Experience is something you don't get until just after you need it.

Offline pankajcops

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Re: Regarding potency calculation
« Reply #7 on: February 28, 2008, 10:50:45 PM »
I was not telling you to do the same thing twice, You presented two problems:

The first used a sample of Esomeprazole magnesium dihydrate;
The second used a sample of Esomeprazole magnesium dihydrate which had been dried (effectively removing the water content)

Let me try and clarify this once again:

For the first problem, you have Esomeprazole magnesium dihydrate and an "as is" potency value: When applied,this potecy will give you the Esomeprazole magnesium concentration as the "as is" potency will account for the water content and any impurities in the Esomeprazole magnesium.

From molecular weight data, you can calculate the percentage of Esomeprazole in  Esomeprazole magnesium.  Applying this value will enable you to calculate the amount of  "pure"  Esomeprazole in your
original Esomeprazole magnesium dihydrate sample.

In the second problen, you have taken Esomeprazole magnesium dihydrate which has been "dried"  (effectively removing the water content).this leaves you with Esomeprazole magnesium and any impurities in the material. In this case, the "as is" potency is of no use to you and you will now need to find a purity value for the Esomeprazole magnesium which does not include the water content. I would normally use a purity value (determined by HPLC or UV, etc.) which should be present on the certificate of analysis. Once this value is applied you have a "pure" Esomeprazole magnesium  concentration. From the mw data you can then caclulate "pure" Esomeprazole content in the sample.
Thanks for your reply and cooperaration.

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