Stability of alemtuzumab in infusion-bags

Pharmazie

Volumn 64, Issue 9, 2009, Pages 622-623

  Kupfer, Mathias ^a,b   Scriba, G ^b   Hartmann, M ^a  

^a JENA UNIVERSITY HOSPITAL   (Germany)

^b FRIEDRICH SCHILLER UNIVERSITY JENA   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ALEMTUZUMAB; PHOSPHATE; SODIUM CHLORIDE;

ACCURACY; ANALYTICAL PARAMETERS; ARTICLE; DRUG PACKAGING; DRUG STABILITY; DRUG STORAGE; GEL PERMEATION CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INFUSION BAG; LIMIT OF QUANTIFICATION; LINEARITY; RANGE; ROBUSTNESS; ROOM TEMPERATURE; STATISTICAL PARAMETERS; TIME; VALIDATION PROCESS;

ANTIBODIES, MONOCLONAL; ANTIBODIES, NEOPLASM; ANTINEOPLASTIC AGENTS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG PACKAGING; DRUG STABILITY; INFUSIONS, INTRAVENOUS; PHARMACEUTICAL SOLUTIONS; SPECTROPHOTOMETRY, ULTRAVIOLET;

EID: 75749087660     PISSN: 00317144     EISSN: None     Source Type: Journal    
DOI: 10.1691/ph.2009.9072     Document Type: Article

References (4)

1. Barth J (2002) Alemtuzumab - Zytostatika-Monographie der Arbeitsgruppe Onkologie im ADKA-Ausschuss Klinische Pharmazie (AO), Krankenhauspharmazie 23: 344-345.
2. FACHINFORMATION: MabCampath® (2006) Bayer Schering Pharma AG
3. ICH (2005) Harmonised Tripartite Guideline: Validation of Analytical Procedures: Text and Methodology Q2(R1), Current Step 4 version.
4. Apv (1985): Haltbarkeit und Haltbarkeitsprüfung von Arzneimitteln. Apv-Richtlinie mit Kommentar, Pharm Ind 47 (6).