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Pre-preparation studies were initiated prior to the commencement of pharmaceutical preparation activities. In the
pre-preparation stage, the physical and chemical properties of the active drug component (API) were determined.
For chemical API, the knowledge gained will help you choose the correct salt or polymorphism form and will
support the design and development of your dosage form, both preclinical and clinical use. For bioactive drugs,
pre-prescription studies ensure that the best candidates for CMC characteristics are selected, which will prove
useful in further drug product development. In addition, during the pre-prescription study, the relevant analytical
methods can be optimized for use at a later stage of drug product development.
Below is a list of our pre-formulation screening services (include but not limited to the following):
Active Pharmaceutical Ingredients Analysis (API)
Physicochemical characterizations of active pharmaceutical ingredients are mainly including molecular
structure analysis, solubility profile, stability investigation, pKa determination, solvent/oil solubility, stability,
polymorph screening, partition coefficient, hygroscopicity, permeability measurement, salt form selection,
mechanical properties, and micromeritics. An understanding of the active ingredients’ physical and chemical
characteristics plays a central role in the early stage of drug development. The solubility, for example,
determines whether an injection or liquors can be successfully prepared.
Formulation Design and Screening
CMC Support Service
The scientists and experts of BOC Sciences, who are experienced and specialized in the field of R&D of new drug
products and generic drugs, can provide you with an excellent report of pre-formulation screening. In addition,
the advanced instrumentation, equipment and the principle of “Clients are First” are also the preponderances of