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

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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

 

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 say about us.

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OF SCIENTIFIC, QUALITY AND SERVICE EXCELLENCE
 

For more information about our QC Lab Testing Capabilities – or for answers to questions about any of our analytical services – contact us by email or by phone at 609.655.4047 x 303.

 

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 Analytical Method Development & Validation  •  Impurities   Contaminant Identification  •  Residual Solvents  •  Stability & Shelf Life Services  •   Extractables and Leachables  •  Product Quality Control & Release Testing  •   cGMP Compendial/Raw Materials Testing  •  Cosmetics Products Testing Services  •  QC & Routine Testing  •  Elemental Impurities  • Strict Compliance with cGMP and GLP Requirements 

FDA Registered & Inspected  ISO/IEC 17025:2005 Accredited

A Fully Audited and Approved Contract Analytical Services Vendor 

Johnson & Johnson Globally Quality Approved Analytical Vendor / Johnson & Johnson Consumer Products Company / Colgate Palmolive Company / Proctor & Gamble / Impax Labs / Ethicon / McNeil / Atrium Medical  / Smith & Nephew / Claris / DR.Reddy's / BD  / L'Oreal /MyLan  / Revlon / Hartz / BASF / And Many More