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Home » Services » Analytical Chemistry Services

Analytical Chemistry Services

ALG offers our clients full product chemistry analysis, including chemical characterization of active ingredients, testing of product-specific impurities, physical chemistry analysis and storage stability testing. Our product chemistry testing capabilities include a broad range of antimicrobial active ingredients (AIs) and preservatives using a variety of analytical equipment such as HPLC, GC and autotitrators.

In addition to chemical characterization and physical chemistry tests, Analytical Lab Group is positioned to detect chemical residuals to support your cleaning validation needs. Common chemical residuals that Analytical Lab Group can detect include:

  • Residual Carbohydrate
  • Residual Protein
  • Residual Hemoglobin

All test labs GLP/GMP compliant

Product Chemistry

Enforcement Analytical Method Validation OPPTS 830.1800
Chemical Characterization OPPTS 830.1750
Preliminary Analysis OPPTS 830.1700
Accelerated Storage Stability OPPTS 830.6317
Long-term Storage Stability OPPTS 830.6317
ICHQ2R1 Analytical Method Validation
Forced Degredation Studies
ICH Q1A(R2) Stability Studies
Physical Chemistry:

Analytical Chemistry

USP <791> pH

HPLC Method Development

  • UV/Vis
  • Reverse-Phase
  • Normal Phase
  • Photo Diode Array
  • Size Exclusion

FT-IR

TOC

GC

  • Thermal Conductivity Detector
  • Flame Ionization Detector

Conductivity

Karl Fischer

  • Volumetric
  • Coulometric

Immunoblotting

Cleaning Validation Support

Package Integrity Testing

Product Testing

Thin Layer Chromatography

Wet Chemistry

  • USP <731> Loss on drying
  • USP <281> Residue on ignition
  • Titration
  • USP <841> Specific gravity
  • USP <785> Osmolality/li>
  • USP <831> Refractive index
  • USP <921> Water Determination – Karl Fischer
  • USP <191> Identification Tests – General
  • USP <401> Acid value (free fatty acids) in fats and fixed oils

Water Chemical Testing

Development

  • Full Validation for Non-Compendial Methods
  • Suitability for Compendial Methods
  • Method Development and Validation available upon request.

ALG Compliance Tests

Listings by Qualifying Agency:

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