Benecel DC HMPC
, combined with the experience of Ashland's technical and service support teams, our industry knowledge and our diverse portfolio of chemistries, gives our customers the flexibility to quickly design custom products to address the needs of challenging controlled-release formulations, added Jeff Wolff, group vice president, Pharmaceutical and Nutrition Specialties, Ashland Specialty Ingredients.
Usually, European community herbal monographs established by the HMPC for well-established and/or traditional use cover a range of herbal preparations.
The study follows current HMPC guidelines which aim to provide a general framework and practical approaches on how to assess or test the potential genotoxicity of herbal substances/preparations and how to interpret the results, thereby representing a pragmatic approach to address both scientific aspects of genotoxicity testing and the special needs of HMPs within the current regulatory framework applicable to these products.
As the Ames tests were unequivocally negative (EMEA, 2008), on the basis of the HMPC nonclinical guideline no further genotoxicity testing of valerian root preparations is required (EMEA, 2006b).
This includes the ESCOP monograph (ESCOP, 2003) as well as the assessment report of the HMPC (EMEA, 2007), which do not contain information pointing to any relevant mutagenic properties of valerian root or preparations thereof.
and thereby also underline the validity of the genotoxicity assessment conducted according to the HMPC guidelines EMEA/HMPC/340719/2005 and EMEA/HMPC/67644/2009.