Pharmaceutical Analytics
Pharmaceutical Analytics is the backbone for the quality, safety, and efficacy of medicinal products. It encompasses all analytical processes that ensure manufactured products comply with legal requirements, international guidelines (e.g., GMP), and specifications.
What is Pharmaceutical Analytics?
Pharmaceutical analytics focuses on the testing of raw materials, active pharmaceutical ingredients (APIs), excipients, and finished medicinal products. It addresses the following key questions:
- Does the identity correspond to the declared active ingredient?
- Is the product free from impurities?
- Does the active ingredient content comply with the specifications?
- Does the product meet all requirements for purity, stability, and safety?
Quality Assurance in Pharmaceutical Analytics
Quality assurance is the crucial element for the safety of medicinal products. Analytical tests ensure that only effective, safe, and standardized products reach the patient. The following analyses are performed for this purpose:
- Chromatographic analyses (e.g., HPLC, GC)
- Spectroscopic analyses (e.g., UV, IR, NMR)
- Microbiological tests for microbial load or endotoxins
- Physical Controls (e.g., Melting Point, Particle Size)
Regulatory Compliance
Compliance with legal regulations is equally critical for the market authorization of medicinal products. Analytical results support companies in meeting these requirements (e.g., GMP, ICH, Ph. Eur.). This involves:
- Specifications are verified
- Analytical results are documented
- Validations are performed
- Stability Studies prepared
Our Services
Our Research
Pharmaceuticals have a direct impact on human health. The development and manufacturing of pharmaceuticals are subject to national and international safety and quality standards. Nanolab possesses comprehensive testing and analytical expertise for pharmaceutical companies, covering the entire process from research and development to market authorization.
Our goal is not only to test all pharmaceutical products in accordance with legal requirements but also to contribute to ensuring they meet high safety and efficacy standards.
To ensure medicinal products are safe and effective for patients, they must be manufactured according to the highest quality standards. Nanolab assesses the efficacy and safety of medicinal products in accordance with globally recognized testing standards. This process encompasses a variety of tests, ranging from the analysis of active pharmaceutical ingredients (APIs) and excipients to stability tests. We conduct detailed tests to ensure the safety of medicinal products in healthcare and provide reliable results for manufacturers.
Pharmaceutical formulations consist of specially developed components designed to meet patient needs. Nanolab tests the accuracy and efficacy of formulations to ensure that every product on the market is of the highest quality. Tests such as solubility, dissolution rate, and bioavailability determine a product's efficiency. This provides pharmaceutical manufacturers with accurate results at every step of the process, enabling them to bring the right products to market.
Pharmaceutical products must undergo a stringent regulatory approval process before market launch. Nanolab offers comprehensive services for assessing the regulatory compliance of pharmaceutical products, ensuring that all required tests are conducted. By performing analyses in accordance with GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices), we ensure that pharmaceutical products meet all legal requirements. Furthermore, we provide support in preparing the necessary documentation and analysis reports for regulatory submissions.