From The Corner Lab - Blog Posts

Celebrating 25 Years of HPLC Method Development

Posted by Jim Menoutis on Thu, Mar 16, 2017 @ 03:59 PM

The Chemist February 2017 Newsletter

 

For 25 years Quantex has been involved with developing and validating HPLC methods used to monitor the synthesis and release of drug substances and drug products. Our analytical team has a proven track record of developing methods for oral dosage forms, parenterals, ointments, creams, coated stents and implantables, as well as methods for OTC products.

Our scientists develop analytical methods that are robust, transferable, reproducible, and designed to support and meet regulatory requirements and submissions. Quantex’s method development services ensure that your team makes the best decisions and hits drug development milestones on time and on budget.

Our approach is to work closely with each client collaboratively, to fully understand both the requirements of the method and the nature of the compound(s). Then, through our unique blend of experience, expertise, and focus we evaluate parameters and identify critical quality attributes. Supporting this is our state-of-the-art HPLC laboratories with 18 HPLC/UPLC systems. This allows us to develop HPLC methods that are robust, efficient, stability-indicating, fit for purpose, ranged properly, and that can be quickly validated.

 
 

 

METHOD DEVELOPMENT SERVICES

  • Purity, potency (assay), related substances and impurities quantification
  •  Stability indicating methods. 
  •  Robust methods for fast method transfer. 
  •  Methods utilizing a wide range of detection modes. 
  •  Molecules with unique complexity or physical properties. 
  •  cGMP Raw Material testing. 
  •  API Release testing. 
  •  Reference Standard Qualification. 
  •  Final Product Release testing. 
  •  ICH Stability Programs

HPLC Capabilities

  • 6 Agilent 1100 HPLC systems with degasser, thermostated autosampler, quaternary pump, column oven and photodiode array detector, additional detectors  RI, ELSD and FL.  
  •  2 Agilent 1200 HPLC systems with degasser, thermostated autosampler, quaternary pump, column oven and photodiode array detector, additional detectors  RI, ELSD and FL. 
  •  1 Agilent 1050 HPLC System with degasser, autosampler, quaternary pump, column oven and MWV Detector. 
  •  4 Shimadzu LC2010C HT HPLC Systems with degasser, thermostated autosampler, quaternary pump, column oven and UV detector, additional detectors, RI, ELSD. 
  •  1 Perkin Elmer Series 200 HPLC system with degasser,  thermostated autosampler, quaternary Pump, column oven, UV detector and ELSD. 
  •  1 Perkin Elmer Series 200 HPLC system with degasser, thermostated autosampler, quaternary pump, column oven, electrochemical detector, coulometric detector and pulsed amperometric detectors. 
  •  1 Perkin Elmer 200 with degasser, isocratic pump, autosampler, column oven, UV detector and RI detector.
  • Waters ILC-2 IC system with inline degasser, isocratic pump, suppressor and  conductivity detector.
  • Waters Acquity  I Series UPLC  with in-line degasser, binary solvent manager, sample manager & organizer, column manager/oven and PDA.
 
 
OF SCIENTIFIC, QUALITY AND SERVICE EXCELLENCE
 
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Topics: HPLC, Method Development

New USP Provisions Significant Changes to HPLC System Suitability

Posted by Jim Menoutis on Sat, Jul 21, 2012 @ 07:46 PM

In a revised draft for General Chapter <621>, major changes have been proposed in the Pharmacopeial Forum:

A revision of General Chapter <621> on Chromatography is proposed in the Pharmacopeial Forum (volume 38, edition 2). This new chapter has a major impact on HPLC system suitability tests (SST).

In the current USP 35, adjustments in the mobile phase in gradient conditions are not recommended. Now, adjustments should be possible but as they may cause changes in selectivity, they should be made with caution.

The revised USP chapter now defines for each variable of the SST whether this variable applies for isocratic separations only or for gradient separations, too. In the future, the following parameters of the SST will be possible for gradient separations:

• pH of the mobile phase (+/-0,2)
• Concentration of salts in buffer (+/- 10 %)
• Injection volumes
• Column temperature (+/-10%)

Different length, internal diameter, and/or particle size in the stationary phase in gradient separations are not allowed.

Also the formula for calculating the flow rate will be modified. A new table will also be created to show the interaction between the variables length, internal diameter, particle size, and flow rates for a few significant column configurations. The objective of this is to maintain the performance of the separation system when modifying the SST parameter.

Finally, changes in the chemical characteristics of the stationary phase will be considered a modification to the method and will require full validation.

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Topics: System Suitability, HPLC, USP 621