Technology
Analytics
Release testing services tailored to your needs
Analytical Development Services
Stability Studies
Reference Standard Characterization
Overview
Non-GMP & GMP Oligo Release Testing
The quality of your custom oligo is paramount. We offer comprehensive release testing services designed to meet the highest industry standards. Whether you require non-GMP or GMP release testing, our highly skilled team is here to ensure your oligos meet all regulatory requirements and deliver superior 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
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 for your journey from discovery through clinical development. With our state of the art technologies and in-house expertise, we are committed 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. 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:
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
Stability Studies
Comprehensive non-GMP and GMP stability studies
We offer comprehensive non-GMP and GMP stability studies through our accredited third-party analytical laboratory.
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
Ensuring your reference materials meet the highest quality standards
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.
