ICP-MS Analysis Pharmaceutical Lab Testing
Regulations for heavy metals pharmaceutical testing (Pb-Lead, As-Arsenic, Cd-Cadmium, Hg-Mercury) are now required to be done by USP<233> Elemental Impurities by ICP-MS rather than using previous traditional wet chemistry methods or Atomic Absorption. In fact, the United States Pharmacopeia omitted the wet chemistry methodology for Heavy Metals <231> in favor of USP <233> performed by the ICP-MS analytical instrument. Our ICP-MS instrument can detect metals and minerals at parts per trillion (PPT) levels.
HPTLC Testing for Pharmaceuticals
HPTLC is an extension for thin-layer chromatography (TLC) that allows for better resolution and quantification of compounds at lower limits of detection and separation. HPTLC testing is primarily used to determine quantity and purity of ingredients in pharmaceutical formulations. At NJ Labs, we frequently combine HPTLC testing for impurities in combination with Attenuated Total Reflection – Fourier Transform (ATR-FTIR) infrared spectroscopy for impurities and ingredient identification in pharmaceutical products.
TOC Testing for Pharmaceuticals
Total Organic Carbon (TOC) testing is used in the pharmaceutical industry to determine water quality both in quantifying organic impurities in pharmaceutical water used for drug manufacturing as well as cleaning effectiveness or cleaning validation to detect residual cleaning agents in rinse or swab samples. NJ Labs has extensive experience in TOC testing in support of pharmaceutical manufacturing and we are compliant with the US Pharmacopeia <643> Total Organic Carbon for control and cleaning validation of pharmaceutical water.
Amino Acids Testing in Pharmaceuticals
The best method to detect the purity of an amino acid in pharmaceuticals is the Ninhydrin Positive Substances and Ammonium test, which combines JP (Japanese Pharmacopeia) and EP or BP (European or British Pharmacopeia) methods. This test is a specialty of NJ Labs demonstrates our competence in amino acids testing which includes a validated method on a UPLC with a closed post column derivatization system.