- Impurities
- Metabolites
- Degradation products
- Unknown compounds
- Co-eluting compounds
- Chiral compounds
- Residual solvents
- USP 232/233/2232
- Developing routine Extractable methods
- Extraction Utilizing USP Protocols
- Extractable/Leachable evaluations
- Extractable Screening
- Scientific Instruments & Laboratory Consumables
- Characterization of Extractables
- Simulation Study
- Toxicology Assessment
- FDA Extraction Testing and Controlled Extraction
- Ensuring the compatibility of drug and closure packaging
- Ensuring safety relative to Packaging Adulterants that may enter the supply chain
- Instrumentation used to analyze Extracts ( GC-MS, LC-MS, HPLC, FT-IR, ICP-MS.)
- Accelerated stability
- Degradation kinetics
- Identification of degradation products
- Shelf life
- Loss on drying
- Heavy metals.
- Full Monograph Testing
- Impurity testing
- Appearance
- Molecular Weight Determination
- Deformulation
Many other analytical tests using ( ( GC-MS, LC-MS, HPLC, FT-IR, ICP-MS, etc..)
- Method Development and Validation
- Method Verification and Transfer
- cGMP Drug Release Testing
- Compendial Testing
- Anti-Factor IIA Potency as per USP monograph for heparin sodium.
- Verification of USP methods
- Stability testing
- Anti-Factor IIA Potency
- Verification of USP methods
- EP and USP Monograph Testing
We perform research projects to improve existing products or introduce a complete new line of products. Our services in this area are very extensive and have resulted in state-of-the-art and unique products. We assure you the quality of our work.
We perform research in changing or revising existing methods to improve the process, reduce costs, and minimize procedure time. We perform verification or validation of the methods as required.,
Contact us for the following services:
Analysis
- Residue Quantification
- Binding Assays
- Extractable and leachable Testing-H
- Formulation and Process Development
- Regulatory and Compliance Support
- Litigation Support
- Containers and Closures Testing
- Physico Chemical Testing
Physico-Chemical Testing
- Pore Size Distribution and Bubble Point
- Gas and Liquid Permeability
- Material/ Chemical Characterization
- Compressibility
- Resilience
- Filter Integrity
- Water Uptake
- Durometry
- Plastometry
- Spectrophotometry
- Photolysis
- Calorimetry
Stability
- Shelf Life
- Accelerated Aging
- Verification of compatibility of ingredients and packaging composition
- Controlled Temperature and Humidity across a wide range of conditions
- Cannabinoid profile
- Heavy Metals
- Pesticides
- Potency
- Quantitation and Relative Ratio of CBD and THC
- Residual Solvent
- Moisture Content
- Terpene Profile
CALI is an NJDEP Certified Environmental Laboratory( #) , Our staff prides itself on providing accurate, dependable data in a timely, cost and effective manner. Our lab is committed to developing partnerships with our clients.
We invite you to contact CALI Labs to explore ways we can provide answers for a challenging analytic Environmental project. We are determined that our staff is capable of customizing services and methods that fulfills your inquiries.
- Elemental Microanalysis
- Environmental Analysis,
- Soil Testing
- Chemical Testing
- Waste Water Analysis
- Drinking Water Analysis
- Schools and Daycares
- Hospitals
- Manufacturing Industries
- OLocal Businesses generating waste water
We will come to your facility to pick up grab samples or set up samplers to collect samples. You share your agreement with the state for the type of testing and frequency your business is required by New Jersey State and we will set up the logistics and collect samples and give you results in time to remain compliant and avoid any unnecessary fine.