Raw Materials Qualification

For USP/NF monographs from Acepromazine maleate to Zein, Southern Testing and Research Laboratories is the choice for raw materials testing. We start with years of experience in chemical testing, physical characterization and microbiological analysis. Add in the technologies to address a full range of article-specific identifications, impurity and limit tests and assays. Combine with the ability to execute a comprehensive list of General Chapter methods. Top it off with a superior technical staff working in strict compliance with cGMP guidelines. Southern Testing has all the ingredients necessary for your raw materials qualification needs.

United States Pharmacopeia/National Formulary Testing

Chemical Tests and Assays

   <191> Identification Tests - General

   <197> Spectrophotometric Identification Tests

   <201> TLC Identification Test

   <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

   <401> Fats and Fixed Oils

   <461> Nitrogen Determination

   <466> Ordinary Impurities

   <467> Organic Volatile Impurities

Physical Tests and Determinations

   <631> Color and Achromicity

   <641> Completeness of Solution

   <651> Congealing Temperature

   <731> Loss on Drying

   <741> Melting Range or Temperature

   <781> Optical Rotation

   <791> pH

   <831> Refractive Index

   <841> Specific Gravity

   <911> Viscosity

   <921> Water Determination

Microbiological Testing

   <61> Microbial Limit Tests

   <85> Bacterial Endotoxins

• Monograph-specific Chemical, Microbiological, and Physical Tests

European Pharmacopeia Testing

• Physical and Physio-chemical Methods, Identification, Limit Tests, Assays, Biological Tests

Japanese Pharmacopeia Testing

• General Tests and Monographs

Testing per Client/Vendor Methods