Non-Sterile Products

cGMP Testing of Non-Sterile products requires a diverse set of analytical tools and techniques to demonstrate the Purity, Potency, Identification, and Safety of a wide range of drug application vessels.  Common products classified as Non-Sterile Products include:

  • Solid Oral Dosage Forms
  • Liquid Oral Dosage Forms
  • Topicals
  • Transdermal Patches
  • Silk Protein products

Selecting an analytical partner that is well versed in the comprehensive analytical characterization of Non-Sterile products ensures you receive your time sensitive data in the timeframe that your production facility demands.  The services that BA Sciences offers for Non-Sterile products include:

  • USP <61> and <62> – Ensuring microbial purity requirements are met for Non-Sterile products is critical to release your Drug Product (DP). BA Sciences employes USP methodology to demonstrate suitability prior to release testing.  The microbiology team is well versed in performing testing and developing neutralization strategies on antibiotics, cytotoxic compounds, and Live Biotherapeutic Products (LBPs) where the DP is comprised of microorganisms. 
  • Dissolution – BA Sciences has the capability to perform dissolution testing per USP <711> on Apparatus 1 and 2 for immediate release, extended release, and delayed release drug products. The dissolutions can be analyzed via HPLC, UPLC, GC UV, Atomic Absorption, Auto-titrator or Fluorescence instrumentation. BA Sciences can also support USP <711> and <724> testing of Apparatus 3, 5 and 7 testing for more unique drug product release, as well as supporting closed loop Apparatus 4 testing. Analytical methods range from USP monograph testing, methods developed by BA Sciences or client transferred methods.
  • Raw Material Testing – BA Sciences has a qualified cGMP compliant raw material testing lab that performs USP-NF, Ph. Eur., BP, JP testing, and more, offering a complete pharmaceutical compendial testing solution. In the event that the raw materials do not fit a compendial monograph, standard method, or have a previously developed method to be transferred, the analytical development group can develop and validate a method to measure the specification required for excipient quality or performance needs. 

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