Diteba is a global leader in complex analytical and bioanalytical testing, providing solutions and services to the pharmaceutical, biopharmaceutical and nutraceutical industries. We support both large and small molecule testing for various dosage forms including solids, semi-solids, liquids, aerosols and other special dosage forms. Our work is focused in several core areas including: In Vitro Release Rate Testing (IVRT) services; stability storage and testing; method development and validation and QC testing at our fully accredited facility.

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2. www.diteba.com

3. About us
Diteba is a global leader in complex analytical and bioanalytical testing,
providing solutions and services to the pharmaceutical, biopharmaceutical and
nutraceutical industries.
Supporting both large and small molecule testing for various dosage forms
including solids, semi-solids, liquids, aerosols and other special dosage forms.
Our work is focused in several core areas including: In Vitro Release Rate
Testing (IVRT) services; stability storage and testing; method development and
validation and QC testing at our fully accredited facility.
www.diteba.com

4. In vitro release testing
• We have superior scientific experience and expertise dedicated to method
development and validation of release rate studies for topical formulations,
including creams, lotions, ointments, gels, pastes, less viscous solutions and
suspensions and transdermal patches for both product development and
regulatory purposes.
• Our team possesses in-depth expertise in operating Franz Cell and
Enhanced Cell systems for semisolid, pulmonary and rectal/vaginal
formulations and routinely works with synthetic, biomimesis and tissue
membranes, including human and animal skin.
• As well, our expertise extends to paddle over disk / cylinder apparatus for
transdermal patches.
www.diteba.com

5. In vitro release testing
Our IVRT services include:
• In-process testing for formulation optimization
• Quality control, lot to lot variability
• Skin penetration, depth profiling and absorption studies for Bioequivalence or
Bioavailability evaluation
• In Vitro and analytical method development and validation in full compliance
with SUPAC-SS and FDA requirements
• In Vitro release comparison testing for pre and post-changes formulations
• In Vitro-In Vivo Correlation (IVIVC)
• OECD Test Method 428 – In Vitro Skin absorption studies
• Data interpretation and FDA submission for approval of SUPAC-related changes
www.diteba.com

6. In vitro release testing
In Vitro Release Testing (IVRT) of semisolids and transdermals using Franz Cell system.
• Conforms to FDA Scale-up and Post Approval Changes for Semisolids Guidelines
(SUPAC-SS)
• Conforms to USP Pharmacopeial Forum Vol. 35(3) May - June 2009 Product
Quality and product performance tests for topical and transdermal products
• Defined product quality tests in General Chapter <3>
• Defined product performance tests <725>
www.diteba.com

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8. Analytical services
Method development, validation and method transfer for:
• Potency assay
• Related substances (impurities)
• Dissolution methods
Forced Degradation Studies
Cleaning validation testing
www.diteba.com

9. Analytical services
Quality Control Release Testing
• API, Excipients and Finished Products
• Organic volatile impurities/residual solvents
• Dissolution testing
• Preservative testing
• ICH stability storage and testing
• Physical testing
• Compendial or in-house validated methods or sponsor’s methods
Formulation Development Testing
• In-process testing for formulation optimization
• Physical/chemical properties
• Spectral characterization
• Vehicle compatibility testing
• Solubility testing
• Excipient compatibility studies
• Assay, content and blend uniformity testing for feasibility lots
www.diteba.com

10. www.diteba.com

11. Bioanalytical testing
services
Assay method development, validation and transfers
Expertise in many proven validated methods to quantitatively measure all
types of compounds, small or large molecule, using:
• GC-FID
• UPLC/MS/MS
• HPLC - GFC
• UPLC—UV, FLD, ECD
• Capillary Electrophoresis (CE)
• ELISA (Immunochemistry)
• Gel Image Analysis System
Feasibility assessments
Metabolite identification using LC/MS/MS
www.diteba.com

12. Bioanalytical testing
services
Large Molecule Analysis
• Proteins
• Peptides
• Antibodies
• Oligonucleotides
• Polysaccharides
• Phospholipids, fatty acids
• Other
www.diteba.com
Pre-clinical trial support
• Bioanalysis of drug and metabolites in biological
fluids
• Sample analysis technologies in multiple
biological species and matrices for human and
animal studies
• Toxicokinetic (TK)
Clinical Trial Support
• Pharmacokinetic (PK)
• Bioavailability Studies
• Bioequivalence Studies
• Drug Interaction Studies

13. wwwwww.if.odsiptreobgara.mco.cmom

14. Formulation development
Testing
In addition to providing analytical service support for solid dosage formulations, we also
specially support; Semi-solid, ointment, gel, cream, lotion, emulsion, etc. Specialized
formulation support, such as liposome, spray, liquid dosage form containing lipid,
protein or antibody also available.
Testing Includes;
• Vehicle compatibility testing
• Solubility testing
• Excipient compatibility studies
• Bench level formulation development contract services available
www.diteba.com

15. wwwwww.if.odsiptreobgara.mco.cmom

16. Physical testing services
• Loss on Drying, ROI
• Moisture (Karl Fisher Titration & Coulometric)
• Color Determination
• Deliverable Volume
• Density & Specific Gravity
• Disintegration
• pH and Conductivity
• Product & Package Appearance
• Tablet Hardness & Friability
• Viscosity, Osmolarity, Particulates, TOC
www.diteba.com

17. wwwwww.if.odsiptreobgara.mco.cmom

18. Stability & storage testing
• Drug products and substances
• CTM, IND, NDA, ANDA Registration batches
• Comparator products
• Commercial products
• Controlled substances and precursors
• Formulation evaluation stability testing
• Forced degradation studies
• Photo stability (UV and Daylight) per ICH
Q1B
• Temperature cycling (freeze/thaw)
• Transportation studies
• Protocol design and report writing
www.diteba.com

19. Stability & storage testing
Long-term and accelerated storage conditions per ICH Guidelines:
• 25oC/60% RH
• 30oC/65% RH
• 40oC/75% RH
• 5oC, -20oC, -80oC
Special storage conditions available
Our temperature/humidity stability chambers are continuously monitored by
the fully Validated Rees Scientific CENTRON Monitoring System® . It provides
instant data regarding the individual storage condition while ensuring
compliance with FDA 21 CFR 11.
Our natural gas powered roof top generator ensures continuous power during
power failures for all stability chambers, fridges and freezers.
www.diteba.com

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21. Dissolution testing
• Method development and validation
• Immediate and controlled release testing
• Testing per USP monograph articles or in-house
methods
• Drug release testing
www.diteba.com

22. Key equipment
State-of-the-art instrumentation including:
• HPLC
• UPLC, UPLC-MS/MS
• GC-FID
• AA
• UV, FT-IR
• Dissolution systems
• Franz Cell and Enhancer Cell systems
• ELISA readers
• Capillary & Gel Electrophoresis
• SDS-Page EP
• TOC
• Stability chambers
• Physical testing equipment
www.diteba.com

23. Key equipment expansion
• Purchased and qualified a Waters® Xevo™ TQ-S mass spectrometer coupled
with the ACQUITY UPLC® I-Class system. Designed for the most demanding
quantitative UPLC/MS/MS applications and additional
• Doubled our IVRT capacity with the purchase and qualification of multiple
Logan Transdermal consoles.
www.diteba.com

24. What do our customers
think?
We recently engaged Diteba to undertake an IVRT study for a topical spray
formulation using the finite dose technique and static Franz Diffusion Cells. Not
only did they resolve some very difficult technical obstacles, but they completed
the project to our complete satisfaction. I am pleased we chose them to be our
IVRT partner.
www.diteba.com
- Dr. Chalil Abu-Gnim, Senior Director, Analytical R&D
“
We are very pleased we contracted Diteba for a wide range of GMP/GLP analytical
work for both biomolecules and small molecules in various dosage forms and drug
development stages, including Phase 1 to Phase 3 products. The work included
method development, validation, drug product release and stability programs. Their
staff was supportive, well-informed and experienced with the most up-to-date
scientific methods, quality practices and regulatory requirements.
- Theresa Horne, MSc. – Director, Analytical Chemistry
“
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25. www.diteba.com