On-Demand Webinar: Challenges with Verification of Compendial Chromatographic Methods
Pace Analytical Life Sciences (PLS) provides raw material testing services to the pharmaceutical, biopharmaceutical and medical device industries. We offer excipient testing to support 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. We also can test following client-supplied or vendor supplied methodology. Our raw material testing supports formulation development within research and development, excipients and active pharmaceutical ingredients used in finished product manufacturing and supports the qualification of our client’s 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 (Atomic Absorption Spectroscopy (AA), Graphite Furnace Atomic Absorption Spectroscopy (GFAA), Inductively-Coupled Plasma with Optical Emission Spectroscopy (ICP-OES), Inductively-Coupled Plasma with Atomic Emission Spectroscopy (ICP-AES), 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
We also provide novel active pharmaceutical ingredient (API) testing.
We understand that our clients need results of their raw materials accurately and quickly. To that end we offer expedited turn around time services so that our clients can count on getting their results to meet their “just-in-time” manufacturing processes.
Pace Analytical Life Sciences brings years of experience performing all types of analytical testing on raw material excipients and active pharmaceutical ingredients. We maintain the highest level of quality and attention to detail to our clients to assure that their raw material testing will be successfully executed. We have a robust Compendial Verification (CV) program administered by our Quality Assurance department. Our compendial specialists closely monitor changes and updates to compendia monographs and general chapters as monograph modernization and international harmonization continues to evolve.
We are FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025 accredited.