Advanced Analytical Method Development & Characterization Support
Empowering Innovation in Complex Dosage Forms
At Rarebio Scientific, we go beyond reference standards. We offer end-to-end support for method development and advanced analytical characterization of complex pharmaceutical formulations.
Our Expertise Spans A Wide Range Of Novel And Challenging Dosage Forms, Including:
- Peptides
- Nanosuspensions
- Depot Formulations like microspheres, in-situ gel.
- Liposomes & Lipid-based Systems
- Iron–Carbohydrate Complexes
- Oligonucleotides
Our analytical scientists bring deep expertise in tackling complex drug delivery systems, ensuring accurate profiling and compliance with global standards.
We integrate advanced method development with cutting-edge instrumentation to address stability, release kinetics, and bioavailability challenges. This approach helps pharmaceutical innovators accelerate development and meet stringent regulatory expectations efficiently.
Analytical Expertise
Comprehensive testing solutions for complex pharmaceutical dosage forms.
Characterization Support
Advanced techniques to profile, confirm, and optimize formulations.
Regulatory Compliance
Accurate data to meet stringent global pharma quality standards.
Our Advanced Characterization Capabilities:
We provide end to end support for product specific physiochemical characterization as per various dosage form platforms.
We use a suite of state-of-the-art analytical techniques for following testing services:
Specialised Testing:
• Encapsulation Efficiency & Drug Loading
• Bound and unbound drug content
• In Vitro Release Studies for long-acting dosage forms and implants by using various advanced dissolution technologies along with USP Type-I to VII.
Physicochemical Characterization:
- Particle Size & Zeta Potential – DLS, Laser Diffraction
- Surface Morphology – SEM, TEM, AFM
- Thermal Analysis – DSC, TGA
- Crystallinity – XRPD, Raman, FTIR
- Structural & Molecular Characterization
- Mass Spectrometry – HRMS, LC-MS/MS, MALDI-TOF
- NMR Spectroscopy – 1D & 2D NMR (¹H, ¹³C, etc.)
- Peptide Mapping – Enzymatic digestion followed by LC-MS
- Sequence Confirmation – Peptides & Oligonucleotides
- Purity & Impurity Profiling
- HPLC/UPLC – Assay, Related Substances, Degradation
- Capillary Electrophoresis (CE) – Charge variants, oligos
- GC – Volatile impurities, residual solvents
- Morphological characterization - By Cryo TEM, SEM, and Advanced Microscopic Techniques
Frequently Asked Questions
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1What Types Of Pharmaceutical Dosage Forms Do You Specialize In Analyzing?
We work with a wide range of complex dosage forms including peptides, nanosuspensions, depot formulations such as microspheres and in-situ gels, liposomes, lipid-based systems, iron–carbohydrate complexes, and oligonucleotides.
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2What Specialized Analytical Testing Services Do You Offer?
Our specialized testing includes encapsulation efficiency, drug loading, bound and unbound drug content measurement, and in vitro release studies for long-acting dosage forms and implants using advanced dissolution technologies (USP Type I–VII).
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3What Physicochemical Characterization Techniques Are Available?
We provide particle size and zeta potential analysis, surface morphology studies, thermal analysis, crystallinity assessment, molecular characterization, mass spectrometry, NMR spectroscopy, peptide mapping, sequence confirmation, purity profiling, HPLC/UPLC, capillary electrophoresis, and GC testing.
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4How Do Your Services Support Regulatory Compliance?
Our end-to-end analytical method development and characterization deliver accurate, validated data that meets global regulatory guidelines, helping pharmaceutical innovators ensure quality, safety, and compliance for their products.