We have the necessary technology to carry out a full analysis of metal traces in APIs, excipients and end products.
We analyse metal traces by ICP-OES emission spectrometry in excipients, raw materials, intermediate and end products in accordance with USP 232 and 233 General Chapters and the ICH Q3D guideline.
- Class 1: As, Cd, Pb and Hg.
- Class 2A: Co, Ni, and V.
- Class 2B: Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se and Tl.
- Class 3: Ba, Cr, Cu, Li, Mo, Sb and Sn.
- Others: Al, B, Ca, Fe, K, Mg, Mn, Na, W, Zn, etc.
We also offer the following services:
- Setting-up and validation of the metal analysis method using plasma emission spectrometers (ICP-OES).
- Assessment in the metal analysis technique using plasma emission spectrometers (ICP-OES) for pharmaceutical products.
- Pharmaceutical laboratories.
Accreditations and Recognition
The Pharmaceutical Development Control Laboratory is certified by the Spanish Agency for Medicines and Healthcare Products (AEMPS) in Good Manufacturing Practice (GMP) guidelines: Physical and chemical quality control medicines for human use and medicines under research.
The manufacturing plant is certified by the Spanish Agency for Medicines and Healthcare Products (AEMPS) in Good Manufacturing Practice (GMP) guidelines: Manufacture and import of pharmaceuticals for non-sterile human use, including psychotropic and narcotic substances / Manufacture and import of non-sterile investigational medicinal products.
The drug manufacturing plant has been granted the ISO 13485 certification for quality management for the medical devices industry.