title: Near-infrared reflectance spectroscopy as a process analytical technology tool in Ginkgo biloba extract qualification.
abstract: Here, we describe the use of near-infrared diffuse reflectance spectroscopy for qualification of Ginkgo biloba extract as raw material for use in pharmaceutical products. G. biloba extract shows unpredicted and uncontrolled variability in some of its quality specifications, intrinsic to its natural origin, which have influence on the manufacturing process of solid dosage forms (viz. granulation and compression). Some of these properties could not be determined by conventional quality control tests, so we investigated the use of NIR to qualify the batches of Ginkgo extract accordingly to its different features and establish a relationship with some of the manufacturing steps behaviour based on their qualification. Several approaches were evaluated, and the NIR method developed demonstrated to be sensitive to changes in important quality specifications and therefore adequate to qualify incoming batches of G. biloba extract. This could be considered a process analytical technology (PAT) application since it: (1) establishes the source of variability in a qualitative way, (2) explains its propagation to the final product quality attributes and (3) lays the basis for a control strategy to be applied in the manufacturing process.
authors.affiliation: Laboratórios Atral SA, Rua da Estação, 42, Vala do Carregado, Castanheira do Ribatejo, Portugal. silviarosa@ist.utl.pt
authors.forename: Sílvia S
authors.initials: SS
authors.lastname: Rosa
authors.forename: Pedro A
authors.initials: PA
authors.lastname: Barata
authors.forename: José M
authors.initials: JM
authors.lastname: Martins
authors.forename: José C
authors.initials: JC
authors.lastname: Menezes
mesh_terms: D020441:Ginkgo biloba / Q000737:chemistry*; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry; D010936:Plant Extracts / Q000032:analysis* / Q000737:chemistry; D011786:Quality Control; D015203:Reproducibility of Results; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D004364:Pharmaceutical Preparations; D010936:Plant Extracts