Determination of Leachables in Orally Inhaled and Nasal Drug Products (OINDP) by GCMS/MS
Extraction of leachables from MDI product components of formulation like Chlorofluorocarbon (CFC) or Hydrofluoroalkanes (HFA) propellants in Metered Dose Inhalers (MDI's) . Due to the time dependent nature of leaching process, leachables in OINDP formulation over the shelf life of the product are determined by appropriate stability studies. Among the leachables, nitrosamines, phthalates and Poly Aromatic Hydrocarbons (PAH) were targeted due to their toxicity and carcinogenicity at low concentration levels.
- Content Type:
- Paper
- Document Number:
- PO-CON1548E
- Product Type:
- Mass Spectrometry, Gas Chromatograph-Mass Spectrometry
- Keywords:
- Solid Phase Extraction (SPE), phthalate, nitrosamine, PAH, Chlorofluorocarbon (CFC), Hydrofluoro Alkanes (HFA), nitrosamine, Poly Aromatic Hydrocarbon, Pharmaceutical, Life Science, Development (Formulation, Scale-up, Method development), Drug synthesis and purification, GCMS-TQ8040
- Language:
- English
- File Name:
- ipo215066.pdf
- File Size:
- 375kb
