From The Corner Lab - Blog Posts

CELEBRATING 25 YEARS - LEADERS IN COMPENDIAL AND RAW MATERIALS TESTING

Posted by Jim Menoutis on Tue, Jul 11, 2017 @ 04:08 PM

July 2017; Summer Issue 1

LEADERS IN COMPENDIAL AND RAW MATERIALS TESTING

The manufacture of pharmaceuticals, personal care products or cosmetics   require that the identity, purity, and quality of raw materials be established through the use of suitable test methods. Pharmacopeial and formulary monographs such as the US Pharmacopeia–National Formulary (USP–NF), the European Pharmacopeia (EP), and the Japanese Pharmacopeia (JP) provide standardized test methods for the most common and widely used active ingredients, excipients and raw materials. The ability to analyze  active ingredients, excipients and raw materials requires a wide range of analytical chemistry expertise. While the most common tests performed include titrations, loss on drying, Karl Fisher moisture determination, infrared spectrophotometry, more advance testing is now required by many of these monographs.

Since 1992, Quantex has provided testing for excipients, raw materials and active pharmaceutical ingredients employing compendial methods. Our analytical team has an extensive and  proven track record of performing the testing of raw  materials using compendial methods, as well as methods supplied by raw materials manufacturers. Over the ensuing years, we have continued to expand upon our capabilities, our knowledge and experience. Our laboratories are equipped with state of the art instruments that allow Quantex to performance the extensive chemical testing required to qualify active ingredients, excipients and raw materials .We offer a full suite of chemistry-based testing which includes excipients and active API’s according to current USP, NF, FCC,  EP and JP compendial methods.

 
 

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

 

 

Some of the Many USP Tests We Perform

<191> Identification Tests

<197> Spectrophotometric

          Identification Tests

<201> TLC Identification Test

<206> Aluminum

<211> Arsenic

<216> Calcium, Potassium,

             and   Sodium

<221> Chloride and Sulfate

<231> Heavy Metals

<232><233> Elemental Impurities

<2322> Elemental Contaminants in

           Dietary Supplements

<251> Lead

<261> Mercury

<271> Readily Carbonizable

           Substances

<281> Residue on Ignition

<291> Selenium

<341> Antimicrobial Agents

         Content:

          Benzyl Alcohol

          Chlorobutanol

          Phenol

         Methylparaben

         Propylparaben

<401> Fats and Fixed Oils:

         Specific Gravity

         Melting Temperature

         Acid Value

         Ester Value

         Hydroxyl Value

         Iodine Value

         Peroxide Value

         Saponification Value

         Fatty Acid Composition

<466> Ordinary Impurities         

<467> Residual Solvent

<591> Zinc

 
www.quantexlabs.com

 

Held to the world's

 highest standards

 

See what our clients

 say about us.

Click Here

 

 
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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

Held to the world's highest standards

See what our clients say about us.

Click Here

 
 
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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

Why is ISO 17025, and not just GMPs, Important to You?

Posted by Jim Menoutis on Mon, Mar 28, 2016 @ 10:58 AM

Current Good Manufacturing Practices (cGMPs), are the regulatory framework  mandated by law, and enforced by the US Food and Drug Administration (FDA).  They encompass not only drug (21CFR 210-211), but also dietary supplements (21 CFR 111), pharmacy compounding (21CFR 216),  biologics (21CFR 600-680), medical devices (21CFR 820), and cosmetics.   cGMPs are defined as that part of quality assurance aimed at ensuring products are consistently produced and controlled implementing the quality standards appropriate for their intended use.

They provide systems that assure proper design, monitoring, and control of manufacturing processes and facilities. This includes the establishment of strong quality management systems, robust operating procedures, use of suitable quality raw materials, procedures for detecting and investigating quality deviations, and maintaining reliable laboratory testing capabilities.  It is important to note that cGMPs are minimum requirements.

ISO 17025, General Requirements for the Competence of Testing and Calibration Laboratories, was first published in 1999 as Guide 25, by the International Standards Organization.  In 2005, it was updated as ISO/IEC 17025:2005.   In most major countries, ISO/IEC 17025 is the standard by which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a laboratory that does not hold this accreditation.  The FDA  has issued a Draft Guidance for Industry, Submission of Laboratory Packages by Accredited Laboratories in 2009.This standard comprises five elements - Scope, Normative References, Terms and Definitions, Management Requirements, and Technical Requirements. It is the single most important International Standard governing laboratory quality systems.  Laboratories that are accredited to this International Standard have demonstrated that they have very robust quality systems, are technically competent, demonstrate the calibration and suitability of equipment, and are able to produce precise and accurate test data.

While there are many overlapping similarities between cGMPs and ISO 17025, there is also one significant difference. cGMPs are the minimum requirements mandated by law, and dictate what must be done, but not necessarily how to do it.   ISO 17025, on the other hand, is voluntary, not only dictating what must be done, but also providing the guidance of how to do it.  It is important to note that FDA operates its own laboratories according to ISO 17025, holding third party accreditation under this international standard, as well.   

So why is ISO 17025 important to you?   It helps determine which laboratory can deliver accurate and precise results.  A laboratory that has achieved ISO/IEC 17025:2005 accreditation has met the international standard of testing excellence, demonstrating technical competence, a robust quality system, precise and accurate tests, and suitably calibrated equipment. In fact, the ISO states, "Laboratory customers, regulatory authorities and accreditation bodies may also use ISO/IEC 17025:2005 in confirming or recognizing the competence of laboratories."  A company or vendor  that has implemented a quality system, incorporating both cGMPs and ISO 17025, is displaying a strong commitment to quality, and values the importance that quality plays in the research, development, and manufacturing processes. 

Quantex Laboratories maintains a robust quality system that complies with cGMPs, as well as GLPs. We are also ISO/IEC 17025:2005 accredited, holding the same accreditation scope, and accredited by the same ISO accreditation body  as many of the FDA’s own laboratories  This accomplishment is a tribute to both the robust quality systems, and the broad scope of capabilities  in place at Quantex Labs, as well as the superior technical competency of our staff.    We are also one of the very few labs, nationally, to hold accreditation for Elemental Impurities. Quantex is very proud of this record, and continues to remain committed to quality systems for the integrity of our data.

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Topics: cGMP, FDA, ISO, ISO 17025, Lab Accreditation

New Guidance Available for Elemental Impurities: Meeting Compliance with USP, ICH Q3D, FDA and GMP Requirements.

Posted by Jim Menoutis on Tue, Oct 27, 2015 @ 02:01 PM

A new guide is available covering meeting compliance with USP<232> & <233>, ICH Q3D, FDA’s and GMP requirements. The guide details time lines for compliance, including FDA and EQDM/EMA deadlines for both existing and new drug products. In addition to covering USP’s requirements , it also provides an in depth analysis of FDA’s requirements for complying with ICH Q3D. The guide also covers what will be needed to demonstrate compliance with elemental impurities during FDA GMP inspections.  Click Here to Download


.

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Topics: USP, cGMP, USP <232>, FDA, ICH, Q3D, FDA ANDA,

FDA AND IPEC-AMERICAS PUBLISH STUDY ON ELEMENTAL IMPURITIES IN PHARMACEUTICAL EXCIPIENTS

Posted by Jim Menoutis on Mon, Sep 28, 2015 @ 04:07 PM

On Wednesday, September 23, 2015, the U.S. Food and Drug Administration and IPEC-Americas published their finding on the levels of elemental impurities in select pharmaceutical excipients.

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Topics: USP <232> USP <2332>, Elemental Impurities, 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

FDA Draft Guidance Under FDASIA States That Delaying, Denying, Limiting an FDA Inspection Could Deem A Drug Misbranded or Adulterated

Posted by Jim Menoutis on Thu, Nov 07, 2013 @ 03:27 PM

On July 12, 2013 the FDA released a Draft Guidance,  Guidance for Industry Circumstances  that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, for comment. The Draft Guidance was issued in support of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under Section 707(b) of FDASIA, the FDA was required to issue  guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j).  This is because 501(j) adds a new twist to what is deemed  an adulterated drug.  Specifically, Section 707 of FDASIA adds 501(j) to the Food, Drug, and Cosmetic Act (FD&C Act) to deem adulterated a drug that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.”

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Topics: Establishment Inspection, Inspection, cGMP, Drug facility Inspection, FDA, Aduterated, Misbranded, FDA Inspection