Gel permeation chromatography of dextrans in parenteral solutions: Calibration procedure development and method validation

Journal of Pharmaceutical and Biomedical Analysis

Volumn 41, Issue 4, 2006, Pages 1260-1267

  Karmarkar, S ^a   Garber, R ^a   Kluza, J ^a   Koberda, M ^a  

^a BAXTER HEALTHCARE CORPORATION   (United States)

Author keywords

Dextran; Gel permeation chromatography; GPC; USP; Validation

Indexed keywords

DEXTRAN 40; DEXTRAN 70; GLUCOSE; PARENTERAL SOLUTION;

ACCURACY; ARTICLE; CALIBRATION; COMPUTER PROGRAM; CURVE FITTING; DRUG DEGRADATION; DRUG DISTRIBUTION; GEL PERMEATION CHROMATOGRAPHY; MOLECULAR WEIGHT; OXIDATION; PRIORITY JOURNAL; TEMPERATURE ACCLIMATIZATION; VALIDATION PROCESS;

CHROMATOGRAPHY, GEL; DEXTRANS; PARENTERAL NUTRITION, TOTAL; REPRODUCIBILITY OF RESULTS;

EID: 33646837112     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2006.03.028     Document Type: Article

References (10)

1. Nilsson K., and Soderlund G. Acta Pharm. Suec. 15 (1978) 439-454
2. Alsop R.M., and Vlachogiannis G.J. J. Chromatogr. 246 (1982) 227-240
3. USP monographs on Dextran 40, USP 28, NF 23, 2005.
4. USP monographs on Dextran 70, USP 28, NF 23, 2005.
5. Nilsson G., and Nilsson K. J. Chromatogr. 101 (1974) 137-153
6. ICH Harmonised Tripartite Guideline, Text on Validation of Analytical Procedures, Q2A, dated 10/27/1994.
7. Section 2.2.39, Molecular mass distribution in dextrans, European Pharmacopoeia 5.1, 2005.
8. Kristensen H.I., Tromborg E.M., Nielsen J.R., Nielsen J.I., Johansen K.B., and Ostergaard P.B. Thromb. Res. 64 (1991) 131-141
9. Guidance for Industry: Analytical Procedures and Methods, Validation. Draft Guidance (2000), US Department of Health and Human Services, FDA, CDER, CBER
10. ICH Harmonised Tripartite Guideline, Stability Testing: Photostability Testing of New Drug Substances and Products, Q1B, dated 11/6/1996.