Analytical Services
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Analytical Method Transfer
Codis seamlessly adopts your existing testing methods using our rigorous method transfer systems and experience. Consistent and reliable method performance between laboratories is assured through transfer protocol options, including comparative testing, co-validation, or revalidation. Our lifecycle management approach assures that your test methods remain fit for purpose and compliant with regulatory expectations.
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Analytical Method Validation
Codis upholds high standards for analytical method validation, ensuring that every test we deploy, whether for process control, batch release, or product stability monitoring, is robust, accurate, and reproducible.
Our validation program aligns with the requirements outlined in ICH Q2 tripartite guidance and all applicable global compendial requirements. By applying a lifecycle-based approach rooted in mature change management and continuous improvement systems, we ensure your test methods – and the data they produce – are ready to support constantly evolving markets and regulatory expectations.
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Quality Control and Release Testing Services
Our QC testing services ensure that every raw material, API, and finished product meets stringent regulatory, safety, and performance standards before a qualified person (QP) release. Additionally, rapid turnaround times and thorough documentation processes ensure timely supply to the global market while meeting all regulatory requirements.
Instrumentation & Testing Capabilities
Chemical Analysis
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High-performance liquid chromatography
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Ultra-high performance liquid chromatography
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Liquid chromatography with mass spectrometer detection
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Gas chromatography
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Thin-layer chromatography
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Moisture analysis (coulometric, volumetric, oven-assisted coulometric)
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UV-vis spectroscopy
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FT-IR spectroscopy
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Near infrared spectroscopy
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Nuclear magnetic resonance spectroscopy
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Total organic carbon
Physical Characterization
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Particle size distribution
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Powder X-ray diffraction
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Modulated differential scanning calorimetry
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Scanning electron microscopy
Microbiological Testing
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Viscosity Refractive index
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Gel electrophoresis silver staining (protein detection)
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Enzyme activity
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Protein determination
Microbiological Testing Services
Manufacturing Support
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Bioburden testing for water loop
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Water endotoxin testing
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Environmental monitoring (viable and non-viable) for Grade D areas
API & Finished Product
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Microbial enumeration and identification
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Absence of specified pathogens
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Endotoxin testing – gel clot and turbidimetric
Stability Testing Services
Our stability testing services are guided by the International Conference on Harmonization (ICH) Tripartite Guideline, Stability Testing of New Drug Substances and Products – Q1A(R2), thereby meeting requirements for drug substances and products marketed in the United States, Europe, and Japan.
Long-Term and Accelerated Stability
Testing under ICH storage conditions to support product shelf-life determinations
Product Distribution
Assess response to elevated stress conditions resulting from extreme temperature and humidity levels in transportation
Freeze-Thaw Studies
Test the integrity of drug products after undergoing freeze-thaw cycles
Forced Degradation Studies
Understand degradation pathways when exposed to external stressors
Photostability Testing
Assessment under light exposure conditions
Custom Study Designs
Adapted for clinical trial materials, new formulations, or reformulations
Discover Codis
Explore how Codis applies its expertise in spray drying, microencapsulation, continuous granulation, final dosage forms, and functional products to meet your formulation and manufacturing needs.
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Commercial Spray Drying
Full lifecycle, development, and production expertise for high-volume commercial aqueous spray drying.
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Codis Amorphous Solid Dispersion (ASD)
Industry-leading know-how to design, scale, and manufacture amorphous solid dispersions for improved bioavailability of poorly soluble compounds.
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Microencapsulation
Proprietary microencapsulation processes to improve taste, odor masking, stability, or release profile.
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Continuous Granulation
Continuous high-shear granulation to improve flow, compressibility and disintegration.
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Organic & Polymer Chemistry
Advanced organic synthesis and polymer engineering, enabling robust, scalable manufacturing.
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Analytical Services
State-of-the-art instrumentation combined with data-science–driven PAT to provide method development, validation, release, and stability testing services.
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Final Dosage Forms
Leading global experts in direct compression and two-piece encapsulation products for vitamin, mineral and supplement markets.
Codis Insights & Updates
Stay current with the latest in particle engineering science and Codis articles and resources.
Connect with us to explore how our particle engineering, commercial spray drying, formulation, and advanced manufacturing capabilities deliver high-quality, dependable supply for even the most challenging products.