Evaluation of current compendial physiochemical test procedures for pharmaceutical elastomeric closures and development of an improved HPLC procedure

PDA Journal of Pharmaceutical Science and Technology

Volumn 53, Issue 4, 1999, Pages 202-210

  Milano, Christopher J ^a,b   Bailey, Leonard C ^a  

^a RUTGERS UNIVERSITY   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ELASTOMER;

ARTICLE; CHEMICAL ANALYSIS; DRUG MANUFACTURE; EUROPE; GAS CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; JAPAN; MASS SPECTROMETRY; PHYSICAL CHEMISTRY; UNITED STATES;

CHEMISTRY, PHYSICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG CONTAMINATION; DRUG PACKAGING; ELASTOMERS; PHARMACEUTICAL SOLUTIONS; SPECTROPHOTOMETRY, ULTRAVIOLET;

EID: 0032723814     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (7)

1. Smith and R. Nash, Elastomeric Closures for Parenterals, in; K. Avis, et. al. (Eds.) Pharmaceutical Dosage Forms, Pareneteral Medications, Marcel Dekker, New York, 1986, pps. 155-215.
2. Wood. "Validation of elastomeric closures for parenteral use: An overview." Journal of the Parenteral Drug Association. 34: 286-294 (1980).
3. Jenke. "Effect of solution phase composition on the interaction between aqueous model solutes and polymeric container materials." Pharmaceutical Research. 8: 782-786 (1991).
4. Elastomeric Closure for Injections, in; United States Pharmacopoeia 23/National Formulary 18, 1995, pp. 1736-1737.
5. Rubber Closures for Containers for Aqueous Preparations for Parenteral Use, in; The European Pharmacopoeia, 1997.
6. Test for Rubber Closure for Aqueous Infusions, in; The Japanese Pharmacopoeia XIII, 1996.
7. Mathematical Tables, in; R. Weast (Ed.), CRC Handbook of Chemistry and Physics, The Chemical Rubber Company, Cleveland, 1968, pp. A257.