Raman Confocal Microscopy
Reveal information about molecular structures
Raman Confocal Microscopy
Raman Confocal Microscopy is one of the most advanced techniques for analyzing the chemical composition and structure of pharmaceutical materials.
It provides detailed molecular insights into active pharmaceutical ingredients (APIs), excipients, and formulations, allowing for the identification of polymorphs, contaminants, and the spatial distribution of compounds.
At Particle Analytical, we use the Raman Qontor InVia Renishaw – a state-of-the-art system that performs Raman spectroscopy according to several key pharmacopeia monographs:
Ph. Eur. 2.2.48
Outlines the principles and applications of Raman Spectroscopy for identifying chemical compositions in pharmaceuticals.
USP-NF 858
Provides general methods for using Raman Spectroscopy to identify pharmaceutical ingredients.
USP-NF 1858
Offers advanced guidance on applying Raman Spectroscopy in complex pharmaceutical systems.
USP-NF 1776
Offers image analysis of pharmaceutical systems, including Morphologically Directed Raman Spectroscopy (MDRS) – a powerful technique for analyzing particle size, shape, and chemical identity simultaneously.
MDRS is especially valuable in bioequivalence studies, as it helps characterize complex formulations like inhalation products, nasal sprays, emulsions, and suspensions
By combining Raman spectroscopy with particle size and shape analysis, MDRS offers detailed information on the distribution and behavior of APIs within these formulations – helping to ensure that generic drugs are equivalent to their reference products in terms of safety and efficacy.
These standards ensure that the analysis meets strict regulatory requirements for quality and safety in pharmaceutical products.
How Particle Analytical can assist with Raman Confocal Microscopy, MDRS & Bioequivalence Studies
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Molecular Identification
Provides precise molecular identification of pharmaceutical ingredients, detecting and quantifying APIs, excipients, and contaminants. -
Polymorphism Detection
Differentiates between polymorphic forms of drug substances, ensuring the selection of the most stable and effective form for formulation. Raman microscopy can give unique insight into the distribution of polymorphic forms within the powder particles, assisting in understanding of growth and formation of polymorphic impurities in raw material batches at-release or during storage. -
Amorphous Solid Dispersions (ASD)
Mapping of the amorphous solid dispersions can improve limit-of-detection of crystallization that can take place in ASD products, which is crucial for such product stability, dissolution and bioavailability. -
Spatial Distribution Mapping
Delivers high-resolution chemical maps, showing the spatial distribution of compounds within pharmaceutical formulations. -
Morphologically Directed Raman Spectroscopy (MDRS)
Enables determination of particle size distribution of separate ingredients in formulations: powder blends, granules, tablets, suspensions etc. Offers detailed insights into particle size, shape, and chemical identity, critical for bioequivalence studies and for characterizing complex formulations like inhalation products, nasal sprays, and suspensions. -
Contaminant Detection
Identifies foreign particles or contaminants in drug products, ensuring product quality, safety and compliance with regulatory standards. -
Formulation Optimization
Supports the development of optimized formulations by offering detailed chemical and morphological insights into ingredient interactions. -
Quality Control Support
Ensures consistency in product composition, helping to maintain batch-to-batch quality and meet regulatory requirements.
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