Analytical Services

The analytical testing methods used to monitor potency and purity for raw materials, drug substances and drug products are primary views into the quality of materials. Redox Scientific focuses on efficiently developing robust and high- quality analytical methods that deliver reliable results. We have a vast range of capabilities in instrumentation and detectors. We employ a phase appropriate validation strategy to support programs from early clinical to commercial. Our team of experts has a proven reputation for taking on tough challenges and delivering a quality method to our customers.

• Redox Scientific has experienced team capable to lead the process from protocol design to storage, monitoring, analytical testing and documentation.
• A complete range of storage conditions in multiple climatic chambers.
• The stability units have operational back-ups and are fully controlled with 24×7 monitoring and alert systems.
• Customer-specific conditions can also be accommodated.
• Long term and Stress conditions (accelerated). Drug products, drug substance intermediates hold time study.
• Photo stability studies.

Trace metal impurities in pharmaceutical products are determined to prevent their harmful effects on patients.

• We offer elemental analysis using ICP-MS for trace metal analysis.
• ICP- MS is used to assay trace and ultra-trace elements at part per billion (ppb) levels

• Genotoxins (limits less than 200 ppm) are challenging classes of impurities that have proven to be harmful even at low concentrations and as a result regulatory bodies have specifically defined their limits in drug substances and products.

• Isolate process related impurities and degradation products
• Identify and characterize each impurity using modern analytical techniques
• Synthesize identified impurities for further investigation and reference standards

• HPLC
• LC/MS
• GC/MS
• KF
• Titrator
• ICP-MS

We provide a detailed report at the conclusion of each project. The analytical method which is written in a step-by-step format is included in the report. Our project report includes the following parameters:

• Precision
• Intermediate Precision and Ruggedness
• Linearity
• Accuracy
• Range
• Specificity
• Forced Degradation Studies
• Limit of Detection/Limit of Quantization
• Stability of Standard and Sample Solutions
• Photo stability study
• Robustness

• HPLC/UPLC stability indicating methods for assays and impurities
• Chiral HPLC methods for enantiomer resolution
• GC-FID methods for residual solvents
• GC MS methods for potential genotoxic impurities (PGI’s)
• ICP-MS method for elemental impurities
• Discriminating dissolution methods
• Cleaning methods
• Counter Ion methods by titration, HPLC/UPLC or IC
• Particle Size methods

• Raw Material and Intermediates testing
• In process testing
• Drug Substance Release testing
• Reference Standard Qualification
• ICH Stability Programs