DSC purity analysis is based on thermodynamic phase diagrams for substances (purity ≥98%) which undergo a melting point. Impurities
which have eutectic behaviour with the analyte are determined together.
DSC purity analysis obtained from a single melting event of a 1–2 mg sample is, therefore, extremely attractive for the global
assessment of eutectic impurities. The main advantages in early development lie in the very small amount of material necessary
and the very fast analysis time.
However, the DSC purity analysis cannot replace chromatographic methods which deliver specific individual levels of impurities.
Furthermore, a complete validation of a DSC purity method is difficult and time consuming. Despite these limitations, DSC
is the best support for the development of chromatographic methods, for purity profile and stability assessment during pharmaceutical
Parameters of purity determination and validation aspects are discussed. Examples of use in pharmaceutical development are
Authors:Chunhui Dai, David R. Snead, Ping Zhang, and Timothy F. Jamison
Flow chemistry has attracted significant interest in pharmaceutical development, where substantial efforts have been directed toward the design of continuous processes. Here, we report a total synthesis of atropine in flow that features an unusual hydroxymethylation and separation of several byproducts with high structural similarity to atropine. Using a combination of careful pH control in three sequential liquid—liquid extractions and a functionalized resin, atropine is delivered by the flow system with >98% purity.
Study of excipients incompatibility with drugs in an early phase of pharmaceutical development is still a persistent difficulty
within the pharmaceutical industry. We examine here the compatibility between an experimental drug (nebicapone) and common
excipients using differential scanning calorimetry (DSC), high sensitivity DSC (HSDSC) and a conventional heat stress test.
The results obtained indicate that nebicapone may be compatible with lactose monohydrate and sodium croscarmellose but is
incompatible with magnesium stearate. This study concludes that HSDSC, in stepwise isothermal mode, may be used as a potential
tool for detecting excipient incompatibilities.
Authors:Pintu B. Prajapati, Kunjan B. Bodiwala, and Shailesh A. Shah
registration of pharmaceuticals for human use, ICH Harmonized Tripartite Guideline, Geneva, 2003.
International Conference on Harmonization Tripartite Guideline “Q8, PharmaceuticalDevelopment”, Step 4 version, Geneva
Authors:Libby Yoerg, M. Ellen Matthews, Lakshmi Kaza, Naullage Indika Perera, David W. Ball, John Moran, and Alan T. Riga
is to differentiate the amorphous and crystalline content of three monosaccharides using thermal analytical methods. Amorphous materials are of increasing interest in pharmaceuticaldevelopment because they have more bioavailability and increased
Authors:A. Foppoli, L. Zema, A. Maroni, M. Sangalli, M. Caira, and A. Gazzaniga
at an early identification of all possible crystalline modifications, are nowadays a fundamental step in the pharmaceuticaldevelopment of new drugs and drug products [ 1 ].
Theophylline-7-acetic acid (1,2,3,6-tetrahydro-1,3-dimethyl-2
Authors:Gregory A. Price, Debasis Mallik, and Michael G. Organ
risks in pharmaceutical products originating from the manufacturing conditions. PAT-enabled tools are defined as tools that allow process understanding for scientific, risk-managed pharmaceuticaldevelopment, manufacture, and quality assurance. The
Authors:Shun-Li Wang, Yu-Chiau Wong, Wen-Ting Cheng, and Shan-Yang Lin
Solid state characterization and physicochemical property of the active pharmaceutical ingredients (APIs) are fundamental elements in the pharmaceuticaldevelopment from the beginning of drug discovery to the final
Authors:Fakhruddin Ahmed, P. K. Gutch, K. Ganesan, and R. Vijayaraghavan
Ali , Y , Kimura , A , Coffey , MJ , Tyle , P . Pharmaceuticaldevelopment of suspension dosage form Kulshreshtha , AK , eds. et al. Pharmaceutical suspensions: from formulation development to manufacturing . New York : AAPS Press