At Orbit Pharmaceuticals, we provide advanced analytical services to ensure your drug products excel in quality, safety, and efficacy.
Our state-of-the-art facilities and expert scientists deliver precise, reliable solutions tailored to your pharmaceutical needs—from initial development to final release. Dive into our comprehensive capabilities below.
Our Analytical Capabilities
Method Development and Validation
We design and validate analytical methods to meet global standards (ICH, USP, FDA) with unmatched precision.
- Custom Analytical Method Development: We create highly sensitive and selective methods tailored to your specific drug compounds, ensuring accurate detection and quantification.
- Validation for Accuracy, Precision, and Reproducibility: Our rigorous validation process includes statistical analysis to confirm method reliability, meeting regulatory requirements for repeatability and robustness.
- Optimization of Existing Protocols to Enhance Efficiency: We refine your current methods to reduce analysis time, minimize reagent use, and improve throughput without sacrificing quality.
- Transferability Assessment Across Laboratories:We evaluate and ensure methods perform consistently when transferred to different sites, supporting scalability and multi-facility operations.
Stability Testing and Forced Degradation Studies
We safeguard your product’s stability with thorough testing and analysis.
- Comprehensive Stability Testing Under Diverse Conditions: We conduct real-time, accelerated, and stressed studies per ICH guidelines, assessing shelf life under varying temperature, humidity, and light exposures.
- Forced Degradation Studies to Identify Degradation Pathways: Using acid/base hydrolysis, oxidation, and thermal stress, we pinpoint degradation products and risks to optimize formulation stability.
- Shelf-Life Determination with Kinetic Analysis: We provide data-driven expiration dates by modeling degradation rates, ensuring your product remains effective throughout its lifecycle.
- Photostability Testing for Light-Sensitive Compounds:We assess the impact of light exposure per ICH Q1B, critical for protecting photosensitive drugs from degradation.
Raw Material and Finished Product Testing
We ensure quality at every stage with meticulous testing.
- Identity, Purity, and Potency Verification of Raw Materials: Using techniques like NMR, FTIR, and titration, we confirm raw materials meet specifications before production begins.
- Finished Product Analysis for Consistency and Compliance: We test final formulations for uniformity, dissolution rates, and potency, ensuring adherence to your release criteria and regulatory standards.
- Batch-to-Batch Quality Assurance with Advanced Techniques:Leveraging HPLC, GC-MS, and mass spectrometry, we detect variations and maintain consistency across production runs.
- Impurity Profiling and Control Strategies: Weidentify and quantify process-related and degradation impurities, ensuring safety and compliance with stringent limits.
Microbiological and Chemical Analysis
We prioritize safety with detailed microbiological and chemical testing.
- Microbiological Testing for Contamination Detection: We perform sterility, bioburden, and microbial limits testing per USP/EP standards to ensure product safety and cleanliness.
- Chemical Analysis to Identify Impurities and Residual Solvents: Using advanced chromatography and spectroscopy, we detect trace-level contaminants like heavy metals and solvents with precision.
- Utilization of State-of-the-Art Instrumentation:Our labs employ HPLC, GC-MS, FTIR, and more to deliver high-resolution data for complex matrices and regulatory submissions.
- Endotoxin Testing for Pyrogen-Free Products: Weconduct LAL (Limulus Amebocyte Lysate) assays to confirm injectables and critical products are free from endotoxins, meeting safety benchmarks.
Let’s Elevate Your Project
Ready to develop high-quality, compliant, and innovative drug products? Contact us today to learn how we can support your pharmaceutical needs!
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