LexaMed is ISO 13485 Certified, holds a State of Ohio drug license and DEA registration, and maintains a FDA registration for both medical devices and pharmaceuticals. LexaMed offers a full complement of chemistry services in our corporate laboratories in Toledo, Ohio. We offer tests to support routine release testing such protein, hemoglobin, ethylene oxide (EO) residuals, total organic carbon (TOC), high performance liquid chromatography (HPLC), and gas chromatography (GC) analysis.  Additionally, LexaMed can support compounding pharmacies with all of their analytical and microbiology testing needs.

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Ethylene Oxide (EO) Residuals

Testing conducted per ISO 10993-7.

Limited Use Devices (<24 Hours):

  • EO only, one extraction
  • EO and EC, one extraction
  • EO, EG, and EC, one extraction

Prolonged Use (24 Hours-30 Days or permanent use):

  • EO only, one extraction
  • EO and EC, one extraction
  • EO, EG, and EC, one extraction

Additional extractions available.

In-Vitro Toxicology

Cytotoxicity:

  • MEM Elution (ISO Method)
  • MEM Elution (USP Method)
  • Agarose Overlay (ISO Method)
  • Agarose Overlay (USP Method)

4 Grams, 60 sq. cm, or 120 sq. cm is required for testing.  Requirement will vary based on thickness of material

Beyond-Use Date (BUD)

LexaMed will begin by testing compounded preparations to determine the Beyond-Use Date (BUD) for a specific compounded formulation. Initial tests (time zero) are performed to establish a baseline potenc.  Testing is performed through analytical methodology at selected time intervals that is specified by the client.  Progress reports will be published at each given timepoint the client specifies.  LexaMed can store client supplied test articles as requested.

Potency

Potency testing analyzes the active pharmaceutical ingredient(s) in preparations and measures their concentrations.  Per USP Chapter <795> USP has established that the acceptable range of most compounded preparations is typically ±10%, or within the range of 90.0%– 110.0%.  Testing is completed on the preferred equipment, LexaMed’s High Pressure Liquid Chromatography (HPLC).  The HPLC is the preferred method because of its efficient and specific results.

Total Organic Carbon (TOC)

Gas Chromatography (GC) Analysis

Protein- Bradford Assay

Hemoglobin- TMB Assay

pH Determination

Conductivity- USP <645>

Hydrogen Peroxide Titration

Hydrogen Peroxide Titration and Peracetic Acid Titration

USP Monograph Testing

Need a Quick Quote?

Please email your specific request, including name, company name, and desired time frame to LexaMed’s team of experts at sales@lexamed.net.