Product Characterization
Setting New Standards in Pharmaceuticals
Characterising innovative and reference products
Product characterization involves a comprehensive analysis and understanding of the physical, chemical, biological, and functional attributes of a pharmaceutical product. At Profarma, offer product characterization services to ensure the consistency, quality, safety, and efficacy of your products throughout their lifecycle, from early development to commercialization and post-marketing.
Product characterization activities at Profarma are conducted in accordance with regulatory guidelines, ensuring compliance with Good Manufacturing Practices (GMP) and other quality standards. The results of these activities are critical for obtaining regulatory approvals, supporting product labeling, and ensuring batch-to-batch consistency and overall product quality and safety. Additionally, product characterization helps in identifying critical quality attributes (CQAs) and establishing appropriate specifications to maintain product quality throughout its shelf life and use by patients.
Product characterization
Key stage include:
- Confirming the identity and purity
- Determining the exact composition
- Analyzing physicochemical characteristics
- Conducting stability studies
- Assessing the biological activity
- Impurity Profiling
Frequently Asked Questions
What types of analyses are involved in product characterization?
Product characterization includes a variety of analyses such as:
- Structural analysis (e.g., spectroscopy, chromatography)
- Physical properties (e.g., particle size, morphology)
- Chemical composition (e.g., purity, impurities, stability)
- Biological activity (e.g., potency, bioassays)
- Mechanical properties (e.g., hardness, dissolution)
Can Profarma develop custom characterization methods?
Yes, Profarma can develop and validate custom characterization methods tailored to specific product needs. Our team works closely with clients to create robust testing protocols that address unique product attributes and regulatory requirements.
What types of products can Profarma characterize?
Profarma can characterize a wide range of pharmaceutical products, including:
- Small molecule drugs
- Biologics and biosimilars
- Injectable solutions
- Oral solids and liquids
- Topical formulations
- Inhalation products
How can I get started with Profarma’s product characterization services?
To begin, contact Profarma through our website. Our team will discuss your specific needs and provide a tailored proposal for product characterization to ensure your product meets all quality, efficacy, and regulatory standards.