Abstract: The physicochemical stability of Azacitidine Accord, a pyrimidine analogue antineoplastic agent, was assessed after reconstitution with cold water for injection (WFI) and storage in original glass vials and polypropylene (PP) syringes at different temperatures. At 2°C–8°C, stability was observed for 3 days in both containers. At -20°C, stability was maintained for 60 days regardless…

Author(s): Irene Krämer, PhD, Frank Erdnuess, PhD, Judith Thiesen, PhD

azacitidine, physicochemical stability, suspension for injection

DOI: 10.5639/gabij.2024.1302.023

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Abstract: This study assessed the physicochemical stability of Bortezomib Accord 2.5 mg/mL solutions for subcutaneous and intravenous injection under various storage conditions. Bortezomib 2.5 mg/mL solutions for subcutaneous injection remained stable for up to 84 days in punctured vials and…

bortezomib, intravenous injection, physicochemical stability, subcutaneous injection

DOI: 10.5639/gabij.2024.1302.015

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Cabazitaxel Accord in punctured original vials and after dilution with 0.9% sodium chloride solution or 5% glucose solution in non-PVC bottles at the concentrations 0.1 mg/mL and 0.26 mg/mL. Methods: Punctured…

cabazitaxel, concentrated solution, diluted infusion solution, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.027

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Carboplatin Accord 10 mg/mL in punctured original vials and polypropylene (PP) syringes as well as after dilution with commonly used infusion fluids in polyethylene (PE) bottles at two different concentrations (0.3…

carboplatin, concentrated solution, diluted infusion solution, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.020

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Cisplatin Accord 1 mg/mL in punctured original vials and polypropylene (PP) syringes as well as after dilution with 0.9% sodium chloride solution in polyethylene (PE) bottles at two different concentrations (0.01…

cisplatin, concentrated solution, diluted infusion solution, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.021

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Cytarabine Accord 100 mg/mL in punctured original vials and after dilution with 0.9% sodium chloride solution in polyolefine (PO) bags stored at room temperature. Methods: Cytarabine Accord 100 mg/mL was diluted with…

concentrated solution, cytarabine, diluted infusion solution, physicochemical stability

DOI: 10.5639/gabij.2024.1302.024

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Docetaxel Accord infusion solutions 0.3 mg/mL and 0.9 mg/mL in non-PVC-bags either pre-filled with 0.9% sodium chloride solution or 5% glucose solution for up to 98 days. Methods: Docetaxel Accord 20 mg/mL…

diluted infusion solution, docetaxel, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.028

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Epirubicin Accord 2 mg/mL concentrate in original glass vials after first opening and after transfer to polypropylene (PP) syringes as well as diluted Epirubicin Accord solutions 0.1 mg/mL, 1.6 mg/mL in 0.9%…

concentrated solution, diluted infusion solution, epirubicin, physicochemical stability

DOI: 10.5639/gabij.2024.1302.012

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Doxorubicin Accord 2 mg/mL concentrate in original glass vials after first opening and after transfer to polypropylene (PP) syringes as well as diluted Doxorubicin Accord solutions (0.05 mg/mL, 1.6 mg/mL) in 0.9%…

concentrated solution, diluted infusion solution, doxorubicin, physicochemical stability

DOI: 10.5639/gabij.2024.1302.011

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Etoposide Accord concentrate in punctured vials and after dilution to the concentrations 0.2 mg/mL, 0.4 mg/mL and 0.45 mg/mL in commonly used infusion fluids and containers. Methods: Test solutions were prepared aseptically…

concentrated solution, diluted infusion solution, etoposide, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.018

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To assess the physicochemical stability of fludarabine in punctured original vials and after dilution with 0.9% sodium chloride solution at three different concentrations (0.25 mg/mL, 1.2 mg/mL, 6.0 mg/mL) in commonly used infusion containers. Methods: Test solutions were…

concentrated solution, diluted infusion solution, fludarabine, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.031

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Fluorouracil Accord 50 mg/mL solution for injection or infusion in three different types of elastomeric infusion pumps over 42 days, either undiluted (50 mg/mL) or after dilution with 0.9% sodium chloride or…

concentrated solution, diluted infusion solution, elastomeric infusion pump, fluorouracil, physicochemical stability

DOI: 10.5639/gabij.2024.1302.025