The FDA, USP and EP all recognize the use of secondary standards and working standards that are established with reference to the corresponding primary standard.
Biosolve offers pharmaceutical laboratories and manufacturers a broad range of secondary GC reference standards for various chromatographic and analytical applications. Our secondary GC standards give a convenient and cost-effective alternative to the pharmacopeias primary standards and allow laboratories to focus resources on their core activities rather than preparing internal working standards.
Biosolve secondary GC reference standards are traceable to the current lots of the United States Pharmacopeia (USP); or to European Pharmacopoeia (EP) and British Pharmacopoeia (BP) if available.
Most of our GC reference standards are completely synthetic and typically over 99.9% pure by GC-FID. Identifications determined by GC-MS, FTIR and 1H NMR and reported in the certificate of analysis of each manufactured lot.
Our certificates of analysis for each manufactured lot contain the following comprehensive data:
Analytical methods for determining the purity and the assay.
Handling and storage conditions.
Manufacturing and expiration dates of each standard.
Traceability data to specific current lot of primary standard.
Search GC reference standard for available solvents.