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Residual Moisture Testing of Lyophilized Products  

Course "Efficient Residual Moisture Testing of Lyophilized Products" has been pre-approved by RAPS as eligible for up to

 

1.5 credits towards a participant's RAC recertification upon full

  

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Date & Time:

Instructor Profile:

Tuesday, June 12, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 90 Minutes

Instructor: Jeff Schwegman

Location: Online

Price : $245.00

Jeff Schwegman Founder and CEO, AB BioTechnologies LLC

(for one participant)

Overview: This webinar will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-died products in vials, to foods. Understanding the different techniques, their limitations, and proper execution will result in more accurate and precise moisture results, which translates into better quality products with longer shelf lives.

Why Should You Attend: Monitoring and controlling residual moisture in powders, lyophilized solids, foods, etc can be a critical factor in achieving and maintaining quality products throughout their expected shelf life. Improper levels of moisture in products can result in poor powder flow properties, spoilage, polymorph changes, changes in compaction properties, microorganism growth promotion, higher degradation kinetics, and in the case of freeze-dried products, loss of physical structure and changes in reconstitution properties. There are several methods typically employed to determine residual moisture, and the choice of method will be based on the sample tested, the level of residual moisture present, and the accuracy and precision required for testing. Additionally, many of these methods require a skill and knowledge in preparing and testing the samples if accurate results are to be achieved.  

Areas Covered in the Session: l l l l l

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Thermal properties of formulated products How and where residual moisture is trapped in products Effects of residual moisture on dried products Gravimetric methods for residual moisture testing Near infrared spectroscopy method for residual moisture testing Volumetric Karl Fischer titration CoulometricKark Fischer titration Specialized methods of residual moisture testing Proper handling techniques for external extraction in sealed vials

Click here to register for this webinar Learning objectives: l

Choosing the correct residual moisture test for your applications

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Understanding the advantages and disadvantages of the different techniques covered Understanding (via a step by step method) the

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Jeff Schwegman, Ph.D. is currently the founder and chief executive officer of AB BioTechnologies (www.ab-biotech.com) where he develops formulations, lyophilization cycles, determines residual moisture by Karl Fischer, and provides thermal characterization studies including freeze-dry microscopy and DSC. Additionally, Dr. Schwegman specializes in speaking and consulting in parenteral preformulation, formulation, analytical, and lyophilization of both small molecules and large biomolecules. He also holds patents and develops new technologies within the lyophilization field. Dr. Schwegman received his BS in Biochemistry from Indiana University in 1992 and began working at Cook Imaging in Bloomington Indiana, where he gained experience in analytical, formulation and process development. In 1999 he began graduate study in the Department of Industrial and Physical Pharmacy at Purdue University under the direction of Dr. Steve Nail, where his focus of research involved studying changes in the physical structure of biological molecules during lyophilization. ...more

propertechnique for conducting a coulometric Karl Fischer external extraction (including equations)

Who Will Benefit: This webinar will provide valuable assistance to those companies involved in the handling of powders, lyophilized products, solid

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Residual Moisture Testing of Lyophilized Products