Analytics

Release testing services tailored to your needs

Analytics: Non-GMP & GMP Drug Substance Release Testing
Analytical services

Non-GMP & GMP Drug Substance Release Testing 

At Oligo Factory, we understand that the quality of your product is paramount. We offer comprehensive release testing services designed to meet the highest industry standards. Whether you need non-GMP or GMP release testing, our expert team is here to ensure your products meet all regulatory requirements and deliver top-notch performance. 

  • Purity 
  • Identity 
  • Oligonucleotide Content 
  • Sequence Confirmation 
  • Water Content 
  • Sodium Content 
  • pH 
  • Residual Solvents 
  • Elemental Impurities 
  • Bioburden 
  • Endotoxin 
  • And More 
Analytical Development Services

Analytical Method Development & Validation

At Oligo Factory, we are dedicated to advancing your product’s journey from concept to market. Our Analytical Development and Validation services are designed to provide the comprehensive support you need to ensure your products meet the highest quality standards and regulatory requirements. With our cutting-edge technologies and expert team, we are here to help you navigate the complexities of analytical testing with confidence. 

Our Analytical Development services focus on optimizing and refining the analytical methods used to ensure purity and stability of your product, while our Analytical Validation services ensure that your methods are robust, reliable, and compliant with regulatory standards.

  • AEX, IP-RP & SEC HPLC-UV Method Evaluation, Development and Transfer 
    • Flexible analytical programs 
      • Purity- and stability-indicating analytical methods 
      • Industry standard equipment for ease of transfer 
  • AEX, IP-RP & SEC HPLC-UV Qualification and Validation 
    • Phase appropriate scopes including: 
      • Forced Degradation Studies 
      • Mobile Phase Stability 
      • Solution Stability 
  • Compendial Method Verification 
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Stability Studies 

Oligo Factory provides comprehensive non-GMP and GMP stability studies through our accredited third-party analytical laboratory. Below is the standard testing scope we offer, but we are also able to tailor the scope to include any additional tests. 

  • Appearance 
  • Purity and Impurities: Analyzed by HPLC-UV 
  • Water Content: Determined by Karl Fischer (KF) titration 
  • pH: Measured in a 1% aqueous solution, as per USP <791> 
  • Assay: Conducted using UV spectroscopy 
  • Microbial Enumeration Test (MET): According to USP <61> 
  • Bacterial Endotoxins Test (BET): According to USP <85> 
Reference Standard Characterization 

Reference Standard Characterization services are designed to ensure that your reference materials meet the highest standards of quality. 

Physical and Chemical Properties: Detailed assessments of physical characteristics, such as melting points, solubility, and hygroscopicity, alongside chemical analyses to confirm purity and composition. 

Spectroscopic Analysis: Advanced techniques including NMR, FT-IR, UV-Vis, and MS to elucidate molecular structures and confirm identity. 

Extinction Coefficient Determination: Precise measurement of the extinction coefficient for your reference materials, using UV-Vis spectrophotometry.

Ready to learn more about our analytic services? 

Talk to a Scientist

Address:
56 Boynton Rd, Holliston, MA 01746

Contact:
Phone: (508) 275-3561
Email: Info@oligofactory.com