Robust Analytical Techniques
- From incoming materials to finished products, we ensure stringent quality assurance throughout the entire lifecycle. Our analytical services cover a wide spectrum of techniques, providing comprehensive insights into your products.
Expertise in Key Techniques
Our team boasts expertise in a variety of analytical techniques, including:
- HPLC and UPLC: For precise separation and quantification of compounds.
- FTIR: For identifying and characterizing chemical structures.
- LC/MS and GC/MS:For accurate molecular weight determination and structural analysis of degradation products OR Etractables/Leachables.
- Karl Fischer Moisture Analyzer: For measuring moisture content.
- Dissolution Testing(USP I, II & IV):For assessing drug release rates.
- Particle Size Analysis: For characterizing particle size distribution.
- And many more…
Comprehensive Robust Analytical Techniques:
- At Nivagen, our Analytical Method Development and Validation Services are dedicated to delivering the highest level of analytical precision. Our seasoned team specializes in creating tailored methods for a wide range of complex molecules and formulations.
A Collaborative Approach:
- We believe in the power of collaboration. Our method development and validation experts work closely with our formulation scientists to ensure seamless integration and optimal results. We tailor our methods to your specific needs, ensuring they align perfectly with your desired end formulation.
Comprehensive Drug Product Testing:
- Product quality assurance is our top priority. Our suite of drug release assays covers various dosage forms, including injectables, tablets, and capsules. Our state-of-the-art GLP facilities and experienced team guarantee the highest quality testing.
Accelerating Formulation Development:
- A well-designed method can significantly accelerate your formulation development process. By highlighting lead prototypes based on critical quality attributes, we help you make informed decisions and optimize product development efforts.