USP Provides Information on Recall and Reissuance of USP 33–NF 28
Posted on | January 23, 2010 | No Comments
http://www.usp.org/USPNF/recall.html
USP 32–NF 27 is official at this time and remains official until further notice. USP 33–NF 28, which was released on November 1, 2009 and recalled on January 8, 2010, was not scheduled to become official until May 1, 2010 and should not be used. The current official standards in USP 32–NF 27 can be used with confidence.
Reason for Recall
USP recalled USP 33–NF 28 because of errors that occurred when monographs were redesigned into a new format. The redesign was intended to improve ease of use, streamline presentation, and update and harmonize terminology, but was not intended to change any of the monograph requirements. The effort was comprehensive: all of the ~4000 monographs in the USP 33–NF 28 were redesigned, encompassing more than 4100 pages, over 4 million words, and many figures and tables. While many of the monographs were successfully redesigned, a significant number contained errors.
While USP has an Errata process for issuing corrections to USP–NF on an on–going basis, this process was inadequate to address the number of errors resulting from the redesign. Because maintaining the integrity and accuracy of its standards is of paramount importance, USP recalled USP 33–NF 28 in its entirety.
BioWorld Today: Trial Subscription
Posted on | January 8, 2010 | No Comments
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Nilsen Consulting Webcast
Posted on | November 30, 2009 | No Comments
Join Nilsen Consulting for a webinar entitled “Bullet-Proof Analytical Methods Validation & Performance Monitoring: An FDA/ICH Compliant Six Sigma Approach” On Friday, December 11.
Starting time: 9:30 am, and again at 1:30pm, Eastern Standard Time (New York, GMT-05:00)
Duration: 2 hours
Presenter: Clifford Nilsen
This new, front-line approach, will revolutionize traditional methods validation paradigms, using Six Sigma statistical techniques to ensure proper evaluation of data and setting of meaningful, statistically sound acceptance criteria every step of the way. This is the future of both scientific and regulatory method validation expectations.
Your instructor, Clifford Nilsen, CSSBB, has 40 years experience in the pharmaceutical industry and is a leading expert in analytical laboratory management. He is a Certified Six Sigma Black Belt and has authored two books on analytical laboratory management and operations plus, has written columns for leading industry magazines. He is also a faculty member of the Parental Drug Association and has lectured in the USA and abroad on method validation and related topics.
Register now—No expensive hotel-based per person seminar fees, no travel expense and no lost work time. One registration fee can be used by a single audience, from one person to however many that are interested. All you need is a computer (windows or Mac) that has a speaker. Audio is VOIP. Session is interactive with a 30 minute Q&A session at the end of the presentation. Includes a downloadable copy of the presentation handouts and as a bonus, a traditional method validation protocol and report template.
Session fee (USD$): 475.00
Agenda:
- Introduction
- Overview of Lab Operations and basic statistical methods
- Method Validation – A Six Sigma Approach
- Method Performance Monitoring
- Overview of Measurement System Evaluation
- Question & Answer Period
Session number: 730 876 966
Password: (This session does not require a password.)
Audio conference: Use VoIP only
Host’s name: Clifford Nilsen
Host’s email: cnilsen@nilsenconsulting.com
Gilson introduces FTLC system
Posted on | November 25, 2009 | No Comments
Gilson, Inc., an industry leader in purification systems for HPLC, SPE and GPC clean-up, introduces a solution that will remove 95% water content in fractions thus decreasing dry-down time. Gilson’s Fraction Trapping Liquid Chromatography (FTLC) System is unlike any system on the market today and incorporates the durability of the GX-271 Liquid Handler/Injector, the power of three 306 HPLC Pumps and the precision of the 155 UV/VIS Detector with the ability for column switching via the VALVEMATE® II Valve Actuator.
The Fraction Trapping Liquid Chromatography (FTLC) System is unlike any other product on the market today. The FTLC System is ideally suited for processing fractions greater than 25 mL volume and sample masses up to 500 mg that have been purified on virtually any preparative HPLC system. The collected fractions are re-processed on the FTLC System. While the compounds are trapped on the column, the water content passes through to waste. Washing steps can also be performed for removal of salts, buffers and mobile phase modifiers such as TFA, which can hinder further LC/MS analysis. Fractions containing greater than 50% water content can be processed and collected in 100% organic solvent. This allows for fast dry-down times at lower temperatures for samples that are heat-sensitive, thereby eliminating degradation. Dry-down times of 12–24 hours can be reduced to less than 30 minutes.
They claim it will “Increase Speed of Dry-down while Removing Water Content, Salts, Buffers and Modifiers”. With the introduction of UPLC by Waters, and FTLC by Gilson, it seems like Liquid Chromatography still has a few tricks up its sleeve.
It’s Called epMotion.
Posted on | November 21, 2009 | No Comments
I just got this sent to me from Melissa. I don’t know if I like the video or not. When I first saw it I thought it was a Saturday Night Live, Justin Timberlake spoof video. But this is a Youtube video ad for the epMotion device.
But the video…It’s not geared toward the money/decision makers. It’s geared to the young kid right out of school. But the device itself seems like a good idea. It appears to be every microbiologist’s dream machine. The machine is actually shown very little. But I had to stop the video and back it up to see the device.
Thanks Melissa!
Cutting-Edge Analysis of the Biotech Industry!
Posted on | November 13, 2009 | No Comments
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