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

Elemental Impurities: Where we were then, Where we are now, and Where are we going

Posted by Jim Menoutis on Tue, Sep 22, 2015 @ 05:44 PM

On Wednesday, September 9, 2015 the FDA published the final Q3D Elemental Impurities Guidance for Industry. At the same time, Contract Pharma Magazine published a feature article in its September issue on elemental impurities. The feature discusses elemental impurities in depth with perspectives on USP and regulatory the expectations from both FDA and EMA. The article notes that” …In both Europe and the US, the EQDM/EMA and FDA deadlines for compliance of new marketing authorization and new drug applications, respectively, with ICH Q3D are each set for June 2016…” to access the article in full click below:

Click here to access the article

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Topics: USP <232> USP <2332>, Elemental Impurities, USP <233> elemental Impurities, FDA, ICH

Quantex Issues New Guide on Elemental Impurities

Posted by Jim Menoutis on Tue, May 06, 2014 @ 04:13 PM

Quantex Laboratories has just release a new whitepaper/guide on Elemental Impurities, titled "Elemental Impurities -Preparing For The New regulations and Guidelines". It provides a current overiew of Elemental Impurites and what to expect with  the Deceber 2015 implementation date.

The whitepaper/guide provides a review of Current USP requirements for General Chapters <232>, <233> and <2322>. It also details and compares the new European Pharmacopiea  5.20 "Metal Catalysts or Metal Reagents", and 2.4.40 "Determination of Metal Catalysts or Metal Reagent Residues". The paper also covers the the ICH Q3D guidelines.

 

 

 To download your free copy click here

 

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Topics: USP <232> USP <2332>, Elemental Contaminants in Dietary Supplements, Elemental Impurities, USP <232>, USP <233> elemental Impurities, ICH, Q3D

USP Announces Revised Timeline, Effective Date for Elemental Impurities Limits and Procedures

Posted by Jim Menoutis on Fri, Jan 17, 2014 @ 12:32 PM

In September 2013, the Elemental Impurities Expert Panel reviewed the Step 2 limits of the International Conference on Harmonization (ICH) Q3D Elemental Impurities Working Group, which were released in June 2013 and recommended revisions to General Chapter <232> Elemental Impurities—Limits to partially align with the ICH Q3D limits. In October 2013, the General Chapters—Chemical Analysis Expert Committee endorsed the Expert Panel's recommendations.

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Topics: USP <232> USP <2332>, Elemental Contaminants in Dietary Supplements, Elemental Impurities, USP <233> elemental Impurities, ICH, Q3D

ICH Issues Q3D step 2b Elemental Impurities Guideline; USP & EMA Take Action

Posted by Jim Menoutis on Wed, Aug 28, 2013 @ 05:17 PM

The International Conference on Harmonization (ICH) has started the consultation period on elemental impurities. ICH Q3D - Impurities: Guideline for Elemental Impurities - laying out limits for metallic impurities in pharmaceutical ingredients and preparations and detailing the testing procedures used to detect and measure them.  With the July 26, 2013 issuance of the guideline, Q3D has now entered step 2b of a five-step implementation process. There is a six-month comment period which gives  the industry and other stakeholders time to forward their comments.

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Topics: Elemental Impurities, CHMP, USP <232>, USP <233> elemental Impurities, FDA, ICH, Q3D, EMA

USP Postpones Implementation of Proposed Elemental Impurities

Posted by Mary Oppel on Mon, Jun 03, 2013 @ 05:04 PM

Proposed revisions for General Chapters <232>, <233>, suggested for a May 1, 2014 implementation date, has been deferred. As such, there is no requirement for ANY drug product in the USP-NF to comply with the proposed USP <232>, <233> at this present time.

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Topics: USP <232>, USP <233> elemental Impurities