From The Corner Lab - Blog Posts

Celebrating 25 Years of Elemental Impurities Method Development

Posted by Jim Menoutis on Fri, Apr 21, 2017 @ 05:00 PM

The Chemist April 2017  Issue 2 Newsletter
April 2017 Issue 2 

  

Since 1992, Quantex has developed and executed methods for trace metals (metallic impurities) analysis employing modern quantitative technologies for drug and drug products.  With previous knowledge and experience in trace metals analyses, our founders sought to equip Quantex’s labs with flame and graphite furnace atomic absorption (AAS), as well as inductively coupled plasma (ICP-AES & ICP-MS) capabilities. These capabilities were enhanced with one of the first commercial microwave digestion systems, a CEM MDS-81D.

Over the ensuing years, we have continued to expand upon these capabilities, our knowledge and experience. Today, our laboratories are equipped with state of the art, 5th generation high performance microwave digestion systems, AAS, ICP-AES and ICP-MS systems. These technologies provide both the capabilities and flexibility in meeting the challenges that varying matrices present in the quantitative analysis of trace metals.

Metallic impurities can originate from multiple sources. These sources include catalysts, raw materials used in the manufacture of the API and drug product, glassware, reactors, and equipment used in the storage and handling of starting materials, intermediates, reagents, water and container closure systems. For 25 years Quantex has been involved with developing and validating flame and graphite furnace atomic absorption, ICP-AES and ICP-MS methods used to assess the presence of metallic impurities in API, drug product, medical device, biological tissue, raw materials, and more. 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,regulatory and QA 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 drug, product, or device.  Then, through our unique blend of experience, expertise, and focus we evaluate parameters and identify critical quality attributes.  Supporting this are our state-of-the-art laboratories with multiple AAS, ICP and microwave digestion systems. This allows us to develop and validate methods that are robust, efficient, fit for purpose, and ranged properly.

 
 

FDA Registered & Inspected   Strict Compliance with cGMP & GLP    ISO 17025 Accredited

 
 
 

 

METHOD DEVELOPMENT SERVICES

  • 25 years of experience developing  and executing methods for trace metals  analysis, using modern quantitative technology  for for drug and drug products.
  • ISO 17025 accredited  specifically for USP/ICH Elemental Impurities.
  •  Expertise in troubleshooting complex sample matrices and method challenges.
  • Regulatory experience - asking the right questions to determine the most appropriate testing approach.
  • Pharmacopeia liaison with both USP and EP for clarification, and major industry compendial groups.
  • Focus on service that meets clients' needs-whether a non-GMP general  screening method or a validated GMP analysis that  will withstand regulatory review and scrutiny.
  • Comprehensive instrument capabilities and capacity for method development/validation and rapid  turnaround time on routine analysis.

Capabilities

  • Multiple Milestone state of the art high performance closed vessel microwave digestion systems.  
  • Multiple Hotblock type digestions systems for open vessel acid digestion.
  • Agilent 700 series high speed sequential Axial ICP-AES. 
  • Perkin Elmer 5300DV dual view simultaneous ICP-AES with both radial and axial viewing.
  • Bruker 820 ICP-MS with 90 degree reflecting optics and 9 decade linearity.
  • Cetac U5000AT Ultrasonic nebulizer for use in extending ICP-AES and ICP-MS detection limits 10x lower.
  • Perkin Elmer state-of-the-art 900F flame atomic absorption spectrophotometer.
  • Perkin Elmer state-of-the-art 900Z Zeeman graphite furnace atomic absorption spectrophotometer.
 
 

www.quantexlabs.com

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OF SCIENTIFIC, QUALITY AND SERVICE EXCELLENCE
 
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Topics: USP <232> USP <2332>, Elemental Impurities, USP <232>, USP <233> elemental Impurities, Method Development, Heavy Metals, Trace Metals, ICH Q3D

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