A critical component of any regulatory submission of a NDA or ANDA is the analytical quality package. At Coldstream, our skilled analytical team will develop and validate analytical methods to support the formulation process release of finished product, and ICH stability testing.
The Coldstream analytical laboratories contain state-of-the-art instrumentation, such as HPLC and GC, along with cGMP stability chambers covering -20°C, 2-8°C, 25°C/60%RH, and 40°C/75%RH. Our laboratories are also equipped with a special cytotoxic and potent handling area.
Our highly experienced staff have expertise within all aspects of pharmaceutical analytical sciences. The analytical team collaborates closely with the other Coldstream divisions ensuring success of the project with a goal of exceeding customer expectations.
- ICH Stability Studies
- R&D Stability Studies
- Extractable & Leachable Studies
- Forced Degradation Studies
- Moisture Content
- Residual Solvent Determination
- Cleaning Validation
- Raw Material, In-process and Finished Product Testing
- Dissolution Testing (Immediate and Extended Release)
- Karl Fischer
- Particle Counter
- Density Meter
- Dissolution (Apparatus I and II)
- Milli-Q Water Filtration
Method Development, Qualification, and Validation
At Coldstream, we support clients in developing and validating analytical methods in all stages of drug development, from pre-clinical studies through commercial manufacturing. Our analytical team develops robust methods that are designed according to the phase of drug development. Additionally, our team will transfer and validate existing methods to confirm that analytical procedures are suitable for their intended use.
Analytical Testing Services
Coldstream offers a wide variety of analytical raw material, in-process, and finished product testing services. For additional testing services, please see the services offered by our full service microbiology lab.
- Liquid Chromatography (HPLC)
- Diode Array Detectors (DAD)
- Refractive Index Detector (RID)
- Gas Chromatography (GC)
- Protein Concentration (TOC)
- Infrared Spectroscopy
- Karl Fisher Moisture Analysis (KF)
- pH Determination
- Total Organic Carbon (TOC)
- USP Particulate Testing: HIAC 9705
- Specific Gravity
- Dissolution Testing
In order to ensure the safety and efficacy of your drug product, Coldstream currently offers stability programs with chambers covering -20°C, 2-8°C, 25°C/60%RH, and 40°C/75%RH, as well as an R&D photostability chamber. Our wide variety of testing services, according to the International Conference on Harmonization (ICH) guidelines, will equip you with the data that you need for your filing.