cGMP Compendial/Raw Materials Testing

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Quantex Laboratories performs comprehensive analytical testing of raw materials, active pharmaceutical ingredients, excipients and finished pharmaceutical products. Our services can assist you in the qualification of your vendors or in the release of raw materials for production and manufacturing purposes. Compendial testing is performed in accordance with USP/NF, BP, EP, JP, ACS and FCC methodologies and monographs, as well as with client-supplied or vendor-specified methods.

Quantex’s highly trained scientists, in conjunction with our considerable investment in laboratory resources, can handle the analysis of significant quantities of samples. We maintain well equipped state-of-the-art laboratories that routinely support the analysis of raw materials including actives, fillers, binders, colors, and other excipients. All our laboratory operations and procedures are based on written, detailed SOPs and stringent quality assurance practices in compliance with cGMP regulations.

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USP Chemical Tests & Assays

      USP Physical Tests &             Determinations

<181> Identification – Organic Nitrogenous Bases

<611> Alcohol Determination   

<191> Identification Tests - General

<631> Color and Achromicity

<193> Identification - Tetracyclines

<641> Completeness of Solution

<197> Spectrophotometric

              Identification Tests

<643> Total Organic carbon

<201> TLC Identification Test

<645> Water Conductivity

<206> Aluminum

<651> Congealing Temperature

<211> Arsenic

<698> Deliverable Volume

<216> Calcium, Potassium, and     

            Sodium

<731> Loss on Drying

<221> Chloride and Sulfate

<741> Melting Range or

            Temperature

<231> Heavy Metals

<781> Optical Rotation

<232><233> Elemental Impurities <786> Particle Size Distribution

<2322> Elemental Contaminants in

               Dietary Supplements

<788> Particulate Matter in

            Injections

<251> Lead

 <791> pH

<261> Mercury

<831> Refractive Index

<271> Readily Carbonizable

             Substances

<841> Specific Gravity

<281> Residue on Ignition

<911> Viscosity

<291> Selenium

<921> Water Determination

<341> Antimicrobial Agents

            Content

 

 

 

              Benzyl Alcohol

              Chlorobutanol

              Phenol

Other

  • Monograph-specific Chemical, Microbiological & Physical Tests
  • FCC Monograph-specific Chemical & Physical
  • European Pharmacopoeia Testing
  • Physical and Physio-chemical Methods, Identification, Limit Tests, Assays, Biological Tests
  • General Tests and Monographs
  • Testing per Client/Vendor Methods

 

 

 

 

 

 

 

              Methylparaben and       

               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

<461> Nitrogen Determination       

<466> Ordinary Impurities         

<467> Residual Solvents

<591> Zinc

 

 

USP Chemical Tests & Assays

<181> Identification – Organic Nitrogenous Bases <191> Identification Tests - General <193> Identification - Tetracyclines <197> Spectrophotometric Identification Tests <201> TLC Identification Test <206> Aluminum <211> Arsenic <216> Calcium, Potassium, and Sodium <221> Chloride and Sulfate <231> Heavy Metals <241> Iron <251> Lead <261> Mercury <271> Readily Carbonizable Substances <281> Residue on Ignition <281> Residue on Ignition <341> Antimicrobial Agents Content
Benzyl Alcohol
Chlorobutanol
Phenol
Methylparaben and Propylparabe
<401> Fats and Fixed Oils
Specific Gravity
Melting Temperature
Acid Value
Ester Value
Hydroxyl Value
Iodine Value
Peroxide Value
Saponification Value
Fatty Acid Composition
<461> Nitrogen Determination <466> Ordinary Impurities <467> Residual Solvents <591> Zinc
   

USP Physical Tests & Determinations

<611> Alcohol Determination <631> Color and Achromicity <641> Completeness of Solution <643> Total Organic carbon <645> Water Conductivity <651> Congealing Temperature <698> Deliverable Volume <731> Loss on Drying <741> Melting Range or Temperature <781> Optical Rotation <785> Osmolarity <786> Particle Size Distribution <788> Particulate Matter in Injections <791> pH <831> Refractive Index <841> Specific Gravity <911> Viscosity <921> Water Determination

Other

  • Monograph-specific Chemical, Microbiological & Physical Tests
  • FCC Monograph-specific Chemical & Physical
  • European Pharmacopoeia Testing
  • Physical and Physio-chemical Methods, Identification, Limit Tests, Assays, Biological Tests
  • General Tests and Monographs
  • Testing per Client/Vendor Methods