Development and validation of enzymatic method for the determination of alcohol in immunoglobulin and albumin

Authors

  • D Carrillo-Cabrera Master en Ciencias Farmacéuticas. Empresa Planta de Sueros y Productos Hemoderivados (EPSH) “Adalberto Pessan González”
  • A González-Farah Master en Ciencias Farmacéuticas. Empresa Planta de Sueros y Productos Hemoderivados (EPSH) “Adalberto Pessan González”
  • J Rodríguez-Bernal Master en Ciencias Farmacéuticas. Empresa Planta de Sueros y Productos Hemoderivados (EPSH) “Adalberto Pessan González”
  • Y Suárez-Pérez DraC. Ciencias Farmacéuticas. Profesora Titular, IFAL
  • M Fernández-Cervera DraC. Ciencias Farmacéuticas. Profesora Titular, IFAL
  • J Veliz Rivera Téc. Empresa Planta de Sueros y Productos Hemoderivados (EPSH) “Adalberto Pessan González”

Keywords:

immunoglobulin, albumin, enzymatic method, analytical method validation, alcohol content

Abstract

An enzymatic method for the quantification of alcohol content in immunoglobulin andalbumin was developed and validated. In both materials, the analytical procedure was linear,accurate, precise and specific. The method was linear in the range from 6.0 to 19.0 mg ofalcohol/g of protein to albumin and to immunoglobulin from 9.2 to 27.6 mg of alcohol/g ofprotein, respectively. The proposed method was applied successfully in industrial batches forthe determination of the alcohol content as impurity.

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References

Chapel HM, Lee M. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement. Therapy. J. Clin. Immunol. 2000; 20: 94– 110.

Kazatchkine MD, Kaveri SV. Immunomodulation of autoimmune and inflammatory diseases with intravenous immunoglobulin. N. Engl. J. Med. 2001; 345 (10): 747-55.

Ballow M. Intravenous immunoglobulins: Clinical experience and viral safety. J. Am. Pharm. Assoc. 2002; 42: 449-59.

Evans TW. Rewiev article: albumin as a drug – biological effects of albumin unrelated to oncotic pressure. Aliment. Pharmacol. Ther. 2002; 16: 6-11.

Uhing MR. The albumin controversy. Clin. Perinatol. 2004; 31: 375 -88.

Cohn EJ, Strong L, Hughes WL, Mulford DJ, Ashworth JN, Melin M. Preparation and properties of serum and plasma proteins. IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J. Am. Chem. Soc. 1946; 68: 459-75.

European Pharmacopoeia. 5ta Edition, Council of Europe, Strasbourg. 2001.

British Pharmacopoeia (BP) 2003, (Versión electrónica).

United State Pharmacopeia (USP 30). United States Pharmacopoeia and National Formulary: United States Pharmacopeial Convention. 2007, (Versión Electrónica).

ICH Q2A. Harmonised Tripartite Guideline. Text on Validation of Analytical Procedures. 1995, Disponible en http//www.fda.gov

Shap J. Quality in manufacture of medicines and other healthcare products. Part 5: Quality control. London: Pharmaceutical Press; 2000. p. 283-358.

Quattrochi A, Abelairra de Andizzi I, Laba F. Introducción a la HPLC. Aplicación práctica, Artes gráficas Farro S.A. 1992: 1025.

Popják G. Specificity of enzyme reactions. En: Boyer P.D. (ed.) The Enzymes. 3ra Edición. Vol. 2. Academic Press. 1970: pp. 217-279.

Published

2009-06-20

How to Cite

1.
Carrillo-Cabrera D, González-Farah A, Rodríguez-Bernal J, Suárez-Pérez Y, Fernández-Cervera M, Veliz Rivera J. Development and validation of enzymatic method for the determination of alcohol in immunoglobulin and albumin. Ars Pharm [Internet]. 2009 Jun. 20 [cited 2025 Apr. 3];50(2):63-75. Available from: https://revistaseug.ugr.es/index.php/ars/article/view/4886

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Section

Original Articles