Materials Testing

Avista is equipped to analyze raw materials to USP, EP, ACS or client-defined specifications. Testing can include identification only or an entire certificate of analysis (COA) verification. In many cases, we provide identity testing of all containers used for a manufacturing batch to meet European Union (EU) GMP Guidelines or to verify a COA as part of vendor qualification (as the cost to put procedures in place to test many samples on a non-routine basis can quickly accelerate). Fourier Transform Infrared Spectroscopy (FTIR) is used to identify many Raw Materials. Avista Pharma has built a raw material library from USP- and EP-certified standards analyzed on our FTIR equipped with an Attenuated Total Reflectance (ATR) accessory, allowing us to quickly meet these standards. Many raw materials have specific wet chemistry tests to confirm their identity. Avista Pharma routinely performs these methods that are detailed in USP <191> or the individual USP, EP or ACS monographs. Avista Pharma has the equipment and trained scientists available to meet your raw material testing needs.

 

In addition to specific titration and chromatography assays, a list of the most common USP tests (EP available also) we perform includes:

  • USP <191> Identification Tests – General
  • USP <197> Spectrophotometric Identification Tests
  • USP <201> Thin-Layer Chromatographic Identification Test
  • USP <231> Heavy Metals
  • USP <241> Iron
  • USP <281> Residue on Ignition
  • USP <345> Assay for Citric Acid and Phosphate
  • USP <401> Fats and Fixed Oils
  • USP <467> Residual Solvents
  • USP <611> Alcohol Determination
  • USP <731> Loss on Drying
  • USP <741> Melting Point
  • USP <791> pH
  • USP <841> Specific Gravity
  • USP <921> Water Determination