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Diteba Research Laboratories Inc.
Diteba Research Laboratories Inc., founded in 2003, is a private corporation located in Toronto. The corporation offers the full suite of analytical and bioanalytical testing services for pharmaceutical, biopharmaceutical and neutraceutical industries.
Company Contact:
Sam Ricchezza
Phone:(905) 625-7995
Fax:(905) 625-3767
Email:sam.ricchezza@diteba.com
Website:http://www.diteba.com/
Address:1620 Tech Avenue, Unit 3, Mississauga, ON, L4W 5P4,
Sam RicchezzaPhone:
(905) 625-7995Fax:
(905) 625-3767Email:
sam.ricchezza@diteba.comWebsite:
http://www.diteba.com/Address:
1620 Tech Avenue, Unit 3, Mississauga, ON, L4W 5P4,- Canada
ANALYTICAL
API Type
Service Type
DeformulationDeviceStent/Catheter CharacterizationMethodsMethod DevelopmentMethod TransferMethod ValidationReference Standard CertificationStructure ElucidationTests - Dissolution/DisintegrationDisintegrationDissolution App. I/IITests - Impurities/DegradationForced DegradationImp./Deg QuantitationTests - PhysicalPhysical TestingTablet Hardness/FriabilityTests - Protein/Peptide/DNA/OligoDNA TestingElectrophoresisElisa/Western BlotPeptide mappingProtein Aggregation/DeaggregationProtein Carbohydrate AnalysisProtein Chemical StabilityProtein Dosage FormProtein Primary StructureProtein Secondary/Tertiary StructureTests - StabilityAccelerated StabilityICH/Commercial Stability StorageICH/Commercial Stability TestingPhotostabilityStability Storage (I/II)Stability Testing (I/II)Tests/Analysis - OtherAssay/PotencyComparator AnalysisCompendial TestingContent UniformityFourier Transform Infrared Analysis Investigative AnalysisLCMS AnalysisMetals AnalysisMoisturePolymer analysisResidual Ethylene OxideResidual Solvent AnalysisSample AnalysisThermal Analyses/DSCTrace AnalysisTets - ReleaseIn-vitro release testingLot and Batch Release TestingTopical Formulation/Packaging CompatibilityTransdermal Patch CharacterizationWet Chemistry
BIO-ANALYTICAL
FACILITY REGULATORY STATUS
Facility regulatory bodies
Facility subcategories
PREFORMULATION
General Properties
| Size of the Facilities (square feet) | 10000 |
| Number of People | 30 |
Equipment
| Equipment | Check if exist |
|---|---|
| HPLC | |
| LC-MS | |
| GC | |
| NMR | |
| Solid State NMR | |
| DSC | |
| TGA | |
| FTIR | |
| NIR | |
| Raman | |
| UV-Vis | |
| PXRD | |
| Particle Sizer | |
| Karl Fischer |
HPLC Stability Indicating Methods Developed for Oral formulations (last 3 years)
| Activity/Phase | Oral Tablet | Oral Liquid | Oral Softgel Capsule | Oral Hard Gel Capsule | ODT |
|---|---|---|---|---|---|
| Preclinical | 10 | 6 | 4 | 4 | 2 |
| Phase I – II | 4 | 4 | 3 | 2 | 1 |
| Phase III –commercial | 3 | 3 | 4 | 2 | 1 |
HPLC Stability Indicating Methods Developed for Injectables (last 3 years)
| Activity/Phase | Injectable Solution | Injectable Lyophilized | Injectable Depot | Stents |
|---|---|---|---|---|
| Preclinical | 3 | 3 | 1 | |
| Phase I-II | 3 | 2 | 1 | |
| Phase III-Commercial | 1 | 2 |
HPLC Stability Indicating Methods developed for other formulation types (last 3 years)
| Activity/Phase | Tox Supplies | API | Topical, semi solids, gels | Transdermal Patch | DPI | MDI | Nasal | Ophthalmic |
|---|---|---|---|---|---|---|---|---|
| Phase III-Commercial | 3 | 6 | 4 | 1 | 2 | 2 | 1 | |
| Preclinical | 6 | 6 | 4 | 1 | 2 | 2 | 1 | |
| Phase I-II | 5 | 6 | 4 | 1 | 2 | 2 | 1 |
Dissolution and Drug Release Methods Developed/Validated (last 3 years)
| Activity/Phase | Oral Solid IR | Oral MR Tablet | ODT | Oral Chewable / Gum | Transdermal Patch | Drug Eluting Stents |
|---|---|---|---|---|---|---|
| Preclinical | 3 | 1 | 1 | 1 | 1 | 1 |
| Phase I-II | 3 | 1 | 1 | 1 | 1 | 1 |
| Phase III-commercial | 3 | 1 | 1 | 1 | 1 | 1 |
Delivery Device Characterizations (last 3 years)
| Activity/Phase | DPI | MDI | Nebulizer | Autoinjector | Injection Pen | Needle Free Injector | Prefilled syringe/cartridge | Stents | Transdermal |
|---|---|---|---|---|---|---|---|---|---|
| Preclinical | 1 | 1 | 1 | 6 | |||||
| Phase I-II | |||||||||
| Phase III-Commercial |
