Introducing Medisca Nutraceuticals

Download in electronic PDF format for $25



Search the Complete Journal Archives

Physical and Chemical Stability of Trepostinil Sodium Injection Packaged in Plastic Syringe Pump Reservoirs.

Author(s):  Xu Quanyun A, Trissel Lawrence A, Pham Lien

Issue:  May/Jun 2004 - Andropause
View All Articles in Issue

Abstract:  The objective of this study was to evaluate the physical and chemical stability of treprostinil (as sodium) injections in concentrations of 1, 2.5, 5 and 10 mg/mL packaged in MiniMed plastic syringe pump reservoirs.

Test samples of treprostinil (as sodium) injections having concentrations of 1, 2.5, 5 and 10 mg/mL were packaged as 3 mL of drug solution in 3-mL MiniMed plastic syringe pump reservoirs, sealed with plastic tip caps and stored at –20°C, 4°C, 23°C and 37°C for 60 days. Evaluations for physical and chemical stability were performed initially and throughout the storage periods. Physical stability was assessed using visual observation in normal room light and using a high-intensity monodirectional light beam. In addition, turbidity and particle content were measured electronically. Chemical stability of the drug was evaluated by using a stability-indicating high-performance liquid chromatographic analytical technique.

All samples of treprostinil (as sodium) injection remained free of visible precipitation throughout the study. Little or no change in haze level and in particulates of =10 µm was found. Changes in treprostinil concentration were found to be small; treprostinil sodium concentrations were found to be 95% or greater over 60 days at all temperatures studied.

Treprostinil (as sodium) injections at concentrations ranging from 1 to 10 mg/mL can be packaged in MiniMed plastic syringe reservoirs, stored and shipped with little or no loss of drug stability.

Related Keywords: Pham, Lien, PharmD, Treprostinil sodium injection, chemical stability of, Treprostinil sodium injection, physical stability of, Trissel, Lawrence A., BS, RPh, FASHP, Xu, Quanyun A., PhD

Related Categories: PEER-REVIEWED, STABILITIES, COMPATIBILITIES, STERILE PREPARATIONS

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Physical and Chemical Stability of Trepostinil Sodium Injection Packaged in Plastic Syringe Pump Reservoirs. Xu Quanyun A, Trissel Lawrence A, Pham Lien May/Jun 2004 228-230 Buy
Physical and Chemical Stability of Low and High Concentrations of Morphine Sulfate with Clonidine Hydrochloride Packaged in Plastic Syringes Xu Quanyun A, Trissel Lawrence A, Pham Lien Jan/Feb 2002 66-69 Buy
Physical and Chemical Stability of Low and High Concentrations of Morphine Sulfate with Bupivacaine Hydrochloride Packaged in Plastic Syringes Trissel Lawrence A, Xu Quanyun A, Pham Lien Jan/Feb 2002 70-73 Buy
Stability of Ampicillin Sodium, Nafcillin Sodium, and Oxacillin Sodium in AutoDose Infusion System Bags Zhang Yanping, Trissel Lawrence A May/Jun 2002 226-229 Buy
Physical and Chemical Stability of Hydromorphone Hydrochloride 1.5- and 80-mg/mL Packaged in Plastic Syringes Trissel Lawrence A, Xu Quanyun A, Pham Lien Jan/Feb 2002 74-76 Buy
Stability of Aminocaproic Acid Injection Admixtures in 5% Dextrose Injection and 0.9% Sodium Chloride Injection Zhang Yan-ping, Trissel Lawrence A Mar/Apr 1997 132-134 Buy
Palonosetron Hydrochloride Compatibility and Stability with Three Beta-Lactam Antibiotics During Simulated Y-Site Administration Ben Michel, Trusley Craig, Kupiec Thomas C, Trissel Lawrence A Nov/Dec 2007 520-524 Buy
Physical and Chemical Stability of Palonosetron Hydrochloride with Dacarbazine and with Methylprednisolone Sodium Succinate During Simulated Y-Site Administration Trissel Lawrence A, Xu Quanyun A, Zhang Yanping May/Jun 2006 234-236 Buy
Physical and Chemical Stability of Morphine Sulfate 5-mg/mL and 50-mg/mL Packaged in Plastic Syringes Trissel Lawrence A, Xu Quanyun A, Pham Lien Jan/Feb 2002 62-65 Buy
Physical and Chemical Stability of Palonosetron Hydrochloride with Lorazepam and Midazolam Hydrochloride during Simulated Y-Site Administration Trissel Lawrence A, Xu Quanyun A May/Jun 2005 235-237 Buy