Capzer Pharmaceuticals offers testing of excipients and active pharmaceutical ingredients used in finished product manufacturing following USP/NF (United States Pharmacopoeia/National Formulary), EP (European Pharmacopoeia), BP (British Pharmacopoeia), JP (Japanese Pharmacopoeia), ChP (Chinese Pharmacopoeia), FCC (Food Chemical Codex) and ACS (American Chemical Society, Reagent Standards) monograph testing requirements as well as client-supplied or vendor supplied methodology. The raw material testing for clients is conducted to support their formulation developmentf for research and development, finished product manufacturing, qualification raw material vendors.
Our Raw Material Testing services include:
- Complete Compendia Testing (USP, EP, BP, JP, ChP, FCC, ACS testing)
- USP <467> Residual Solvent Testing
- HPLC (High Performance Liquid Chromatography), Gas Chromatography (GC) and Ion Chromatography (IC) analyses
- Spectrophotometric Analyses (Fourier-Transform Infrared Spectroscopy(FTIR), Ultraviolet-Visible Spectroscopy(UV/VIS, UV-Vis))
- Metals Analyses by Inductively-Coupled Plasma with Mass Spectroscopy (ICP-MS)
- Heavy Metals Testing (ICP-MS)
- Ethylene Oxide and 1,4 – Dioxane Testing
- Plastics Container Testing per USP <661> and <671>
- Purified Water Testing
- Karl Fisher (KF) Analyses
- Wet Chemistry Analyses
Raw Material Testing (USP/NF, EP, JP)
- Formulation Excipients
- Active Pharmaceutical Ingredients (API)
- Compendial Methods (USP / EP / BP / JP / FCC / ACS
- Vendor Qualification
- Cleaning Verification / Validation
- On-site Sampling