Our Analytical Development team plays a critical role in guiding Process Development throughout the entire lifecycle of our customers’ projects.
By working closely with our Process scientists, we ensure the development and validation of reliable, reproducible analytical methods properly tailored to their intended purpose.
Our expertise extends across impurity profiling, active pharmaceutical ingredient (API and HPAPI) quantification, and stability assessment to guarantee both safety and efficacy.
A cornerstone of
our analytical approach
is the implementation of a fit-for-purpose Analytical Control Strategy, guided by a thorough Risk Analysis from our Regulatory Affairs experts.
This strategy covers key regulatory concerns such as Potential and Non-Potential Genotoxic Impurities (PGI/NPGI), nitrosamines, and elemental impurities.
By addressing these risks proactively, we help ensure compliance and streamline the regulatory approval process
Our Stability Study capabilities further reinforce our integrated approach.
We conduct comprehensive stability studies to determine the shelf life of Small Molecule APIs and identify potential degradation products through Forced Degradation studies. This ensures that pharmaceutical products maintain their integrity and meet stringent quality standards over time.
During the critical
phase of process validation
our Analytical Development and Quality Control teams collaborate closely to ensure seamless industrialization.
By validating analytical methods in alignment with manufacturing processes, we guarantee that production consistently meets predefined specifications and quality attributes.
Our team also provides crucial support for regulatory filings by delivering comprehensive analytical data, including solubility studies, hygroscopicity, solid form characterization, and physicochemical profiling.
Compliance with international regulatory guidelines (e.g., EDQM, FDA, ICH) is a fundamental priority for us, facilitating successful drug substance approvals and commercialization.
Beyond compliance, our Analytical Development team actively contributes to continuous improvement efforts.
By leveraging analytical data, we help to maintain control of Critical Process Parameters and optimize the chemistry of manufacturing processes ensuring greater efficiency and product quality.
Our state-of-the-art Analytical
Development Laboratory
is equipped to support Process R&D monitoring from Lab Scale to Commercial, for APIs and HPAPIs.
Our capabilities include:
Solvation and Thermal Analysis
TGA, Vacuum Oven, Halogen Dryer, KF and oven KF
Chromatographic equipment
HPLC/UPLC, IC, GC, GC-HS
Spectrometric
FTIR, NMR, UV-visible, refractometer,
polarimeter, ICP-OES
To enhance process understanding during the R&D phase,
we employ cutting-edge analytical technologies, including:
- LC and GC Mass Spectrometry
- LC Mass (Triple Quad)flexible range of technologies
- High-Resolution Mass Spectrometry (QTOF)
- ICP-MS
- XRPD
At Minakem,
Our fully integrated analytical development approach ensures that our customers’ pharmaceutical projects progress smoothly from R&D to commercialization, with an unwavering commitment to quality, compliance and innovation.