USP Class Testing I-VI

The US Pharmacopeia-National Formulary (USP/NF) provides standardized methods and specifications for generic pharmaceutical raw material and finished products.

US regulatory guidance for pharmaceuticals.

Pharmacopeial monographs such as the US Pharmacopeia-National Formulary (USP/NF) provide standardized methods and specifications for generic pharmaceutical raw material and finished products.  They are utilized as a basic requirement needed for most regulatory submissions in the United States.

USP <87> In-Vitro Biological Reactivity – Cytotoxicity Testing

Cytotoxicity tests are in-vitro assays used to assess the possibility of a test article to cause the death of cells in culture or to prevent their multiplication. The purpose of the study is to determine the potential biological reactivity of a mammalian cell culture (L929) in response to the test article extract.

Testing Categories and Specifications

Test NameSample NeededTurn-Around Time
L929 MEM Elution USP120 cm² ≤ 0.5 mm thick, 60 2-3 weeks
Agar Diffusion USP3 cm2 , 1 g, or 1mL (at least three units, if 1 unit cannot be subdivided into three 1 cm2 samples)2-3 weeks

USP <88> In-Vivo Biological Reactivity – Class I–VI Testing

USP Class tests are assays designed to determine the biological response of animals to direct and/or indirect contact with a test article.

Testing Categories and Specifications

Test NameSample NeededTurn-Around Time
USP Class I 120 cm2 < 0.5 mm thick, 60 cm2 ³ 0.5 mm thick, or 4 g4 weeks
USP Class II240 cm2 < 0.5 mm thick, 120 cm2 ³ 0.5 mm thick, or 8 g4 weeks
USP Class III
USP Class III
480 cm2 < 0.5 mm thick, 1200 cm2 ³ 0.5 mm thick, or 16 g
4 weeks
USP Class IVExtraction-360 cm2 < 0.5 mm thick, 180 cm2 ³ 0.5 mm thick, or 12 g Implant – 12 pieces at 1mm x 1mm x 10 mm4-5 weeks
USP Class V480 cm2 < 0.5 mm thick, 240 cm2 ³ 0.5 mm thick, or 16 g4 weeks
USP Class VIExtraction- 480 cm2<0.5mm thick, 240 cm2 ³ 0.5 mm thick, or 16 g Implant – 12 pieces at 1 mm X 1mm X 10 mm4-5 weeks

USP <381> Elastomeric Closures for Injections

The purpose of the study is to measure the physicochemical properties of impurities extracted from elastomeric closures. The extract solution is analyzed for non-volatile residue, turbidity, acidity/alkalinity, reducing substances, heavy metals, color, zinc, optical absorbance, ammonium, and volatile sulfides.

Testing Categories and Specifications

Test NameSample NeededTurn-Around Time
Physicochemical Test for Elastomeric Closures300 cm²/extract3-4 Weeks

USP <661> Plastic Packaging Systems and Their Materials of Construction

The purpose of this study is to measure the physiochemical properties of impurities extracted from packaging for therapeutic products (pharmaceuticals, biologics, dietary supplements and devices). The plastics used in packaging systems are composed of homologous polymers with a range of molecular weights and contain additives such as antioxidants, stabilizers, lubricants, plasticizers, colorants, and others. The extracted solution undergoes tests for identification of the material, physiochemical properties, and extractable metals.

Available Tests

  • USP 661.1
  • USP 661.2

Plastic Materials of Construction

This monograph calls out several specific materials of construction specifying test and extraction mothods for each type of material

  1. Polyethylene (PE)
  2. Polypropylene (PP)
  3. Polyolefin
  4. Polyvinyl chloride (PVC)
  5. Polyethylene terephthalate (PET)
  6. Polyethylene terephthalate G (PETG)

Each material includes a series of tests to understand the material and extracts from it. These tests include:

  • Identification (FTIR, DSC)
  • Physicochemical Tests (Absorbance, Acidity/alkalinity, TOC)
  • Extractable Metals (ICP/MS, ICP/OES)
  • Plastic Additives, including phenolic and nonphenolic antioxidants (HPLC)

Testing Categories and Specifications

Test NameSample NeededTurn-Around Time
Plastic Materials of Construction300gApproximate turnaround time is based upon study specific parameters.

Plastic Packaging Systems for Pharmaceutical Use

This monograph focuses on the evaluation of your materials in the finished form. This evaluation includes:

  • Physicochemical Tests (Absorbance, Acidity/Alkalinity, TOC)
  • In Polyethylene terephthalate (PET) and Polyethylene terephthalate G (PETG) systems, evaluation of ethylene glycol and total terephthaloyl moieties is also performed

Physicochemical Techniques

  • Differential Scanning Calorimetry (DSC)
  • Fourier Transform Infrared (FTIR) Spectroscopy
  • Total Organic Content (TOC)
  • Inductively Coupled Plasma (ICP)
  • High Performance Liquid Chromatography (HPLC)

Testing Categories and Specifications

Test NameSample NeededTurn-Around Time
Plastic Packaging Systems for Pharmaceutical Use, Physiochemical Testing< 0.5 mm thick, 300 cm2
≥ 0.5 mm thick, 600 cm2
Approximate turnaround time is based upon study specific parameters.
Plastic Packaging Systems for Pharmaceutical Use, Ethylene Glycol & Total Terephthaloyl Moieties Testing< 0.5 mm thick, 500 cm2
≥ 0.5 mm thick, 1000 cm2
Approximate turnaround time is based upon study specific parameters.