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Analytical Chemistry in Pharmaceutical Development

Analytical Chemistry in Pharmaceutical Development. Thursday, March 3, 2016. Effective Analytical Development and QC. In the case of 2 labs conducting QC testing, there may be a difference in rounding and reporting results, particularly when it comes to impurities. These minor differences may not seem like much, but it is likely that if an auditor picks up on these differences the logical question is why are the 2 labs performing differently and which is right. It may, ultimately, make sense to have loca...

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Analytical Chemistry in Pharmaceutical Development | markaschreiber.blogspot.com Reviews

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Analytical Chemistry in Pharmaceutical Development. Thursday, March 3, 2016. Effective Analytical Development and QC. In the case of 2 labs conducting QC testing, there may be a difference in rounding and reporting results, particularly when it comes to impurities. These minor differences may not seem like much, but it is likely that if an auditor picks up on these differences the logical question is why are the 2 labs performing differently and which is right. It may, ultimately, make sense to have loca...

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4 markschreiber01@gmail com

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6 berlex laboratories

7 wayne nj

8 section head/manager

9 dupont pharmaceuticals

10 wilmington de

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Analytical Chemistry in Pharmaceutical Development | markaschreiber.blogspot.com Reviews

https://markaschreiber.blogspot.com

Analytical Chemistry in Pharmaceutical Development. Thursday, March 3, 2016. Effective Analytical Development and QC. In the case of 2 labs conducting QC testing, there may be a difference in rounding and reporting results, particularly when it comes to impurities. These minor differences may not seem like much, but it is likely that if an auditor picks up on these differences the logical question is why are the 2 labs performing differently and which is right. It may, ultimately, make sense to have loca...

INTERNAL PAGES

markaschreiber.blogspot.com

1

Analytical Chemistry in Pharmaceutical Development: Particle Size

http://markaschreiber.blogspot.com/2009/08/particle-size.html

Analytical Chemistry in Pharmaceutical Development. Wednesday, August 12, 2009. Short courses in particle size analysis and dissolution testing are available from the American Chemical Society (www.chemistry.org) and the American Association of Pharmaceutical Scientists (http:/ www.aapspharmaceutica.com/). Mark A. Schreiber, Ph.D. Http:/ www.linkedin.com/in/maschreiber. August 20, 2013 at 11:25 PM. Thanks for this posting. Your blog is very knowledgeable! Keep it always updated. View my complete profile.

2

Analytical Chemistry in Pharmaceutical Development: February 2009

http://markaschreiber.blogspot.com/2009_02_01_archive.html

Analytical Chemistry in Pharmaceutical Development. Friday, February 27, 2009. Analytical Methods for Drug Product. Very often the HPLC methods (assay and impurities) developed for. The API are directly transferable to use with the drug product, depending upon the complexity of the product. The methods to consider for the drug product are:. Dissolution/Disintegration (for solid oral dosage forms). Uniformity of content (content uniformity using USP. Http:/ markaschreiber.blogspot.com/. This area can cove...

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Analytical Chemistry in Pharmaceutical Development: Analytical Methods for Drug Product

http://markaschreiber.blogspot.com/2009/02/analytical-methods-for-drug-product_27.html

Analytical Chemistry in Pharmaceutical Development. Friday, February 27, 2009. Analytical Methods for Drug Product. Very often the HPLC methods (assay and impurities) developed for. The API are directly transferable to use with the drug product, depending upon the complexity of the product. The methods to consider for the drug product are:. Dissolution/Disintegration (for solid oral dosage forms). Uniformity of content (content uniformity using USP. Http:/ markaschreiber.blogspot.com/. Currently: Consult...

4

Analytical Chemistry in Pharmaceutical Development: Spreadsheet for USP <905> Content Uniformity Calculation

http://markaschreiber.blogspot.com/2009/03/excel-spreadsheet-for-usp-content.html

Analytical Chemistry in Pharmaceutical Development. Wednesday, March 4, 2009. At first glance, the acceptance criteria for the content uniformity calculation in USP chapter. I have gone through these calculations and acceptance criteria and created an spreadsheet for the general case. A view of this spreadsheet is shown below. If you email me, I will gladly sent this to you in Excel format. If you have online access to the USP-NF, sign on at. Hhttp:/ www.uspnf.com/. And go to general chapter. Currently: ...

5

Analytical Chemistry in Pharmaceutical Development

http://markaschreiber.blogspot.com/2014/06/marka.html

Analytical Chemistry in Pharmaceutical Development. Monday, June 9, 2014. MARK A. SCHREIBER, Ph.D. Looking for new opportunities as:. Senior Director Analytical Chemistry. Accomplished in Analytical R&D, Quality Control, Pharmaceutical Development, Clinical Supplies, and Stability programs. Successfully led Analytical Development, CMC Development and QC teams. Provided high quality CMC sections for IND's, NDA's, PMA's and supplements. Comprehensive knowledge of CMC regulatory and guidance documents.

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Analytical Chemistry in Pharmaceutical Development

Analytical Chemistry in Pharmaceutical Development. Thursday, March 3, 2016. Effective Analytical Development and QC. In the case of 2 labs conducting QC testing, there may be a difference in rounding and reporting results, particularly when it comes to impurities. These minor differences may not seem like much, but it is likely that if an auditor picks up on these differences the logical question is why are the 2 labs performing differently and which is right. It may, ultimately, make sense to have loca...

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