A new approach to threshold evaluation & quantitation of unknown extractables & leachables using HPLC/CAD

Drug Delivery Technology

Volumn 9, Issue 3, 2009, Pages 50-55

  Yu, Xiaochun ^a   Zdravkovic, Steve ^a   Wood, Derek ^b   Li, Chunyu ^c   Cheng, Yufei ^c   Ding, Xiaoya ^a  

^a PPD's cGMP Lab

^b Product Development Analytical Services Division

^c PPD's cGMP Lab ^*

Author keywords

[No Author keywords available]

Indexed keywords

2 PROPANOL; 3 (3,5 DI TERT BUTYL 4 HYDROXYPHENYL)PROPIONIC ACID OCTADECYL ESTER; 4,4' ISOPROPYLIDENEDIPHENOL; ELASTOMER; PALMITIC ACID; PENTAERYTHRITOL TETRAKIS[3 (3,5 DI TERT BUTYL 4 HYDROXYPHENYL)PROPIONATE]; PHTHALIC ACID DIOCTYL ESTER; STEARIC ACID;

ACCURACY; AEROSOL; ARTICLE; CHEMICAL ANALYSIS; CONTROLLED STUDY; DRUG PACKAGING; EXTRACTION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SENSITIVITY AND SPECIFICITY; ULTRAVIOLET SPECTROSCOPY;

EID: 65349153848     PISSN: 15372898     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (3)

1. Guidance for Industry: Nasal spray and inhalation solution, suspension, and spray drug products - chemistry, manufacturing, and controls documentation. FDA CDER July 2002.
2. Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products, 2006, PQRI.
3. Yu X, Wood D, Ding X. Extractables and leachables study approach for disposable materials used in bioprocessing. BioPharm Int. 2008; 21(2):42-51.