title: Post-reconstitution Stability of Telavancin with Commonly Used Diluents and Intravenous Infusion Solutions.
abstract: OBJECTIVE
  The post-reconstitution chemical stability and microbial challenge hold time of nonpreserved telavancin for injection was determined using common reconstitution diluents and intravenous (IV) infusion solutions stored at room temperature with light (ambient) or at 2°C to 8°C without light (refrigeration).
  
  
  METHODS
  Telavancin was reconstituted with 5% dextrose, 0.9% normal saline, or sterile water (15 mg/mL). Infusion solutions at 0.6 and 8.0 mg/mL were prepared in ViaFlex (polyvinyl chloride) IV bags (Baxter International Inc, Deerfield, Illinois) using 5% dextrose, 0.9% normal saline, or lactated Ringer's solution. Chemical stability was evaluated for up to 14 days under refrigeration and for up to 3 days under ambient conditions. Telavancin concentration and degradant levels were determined using a stability-indicating HPLC method. Solutions were subjected to microbial-challenge testing for up to 48 hours (ambient) or for up to 6 days (refrigeration).
  
  
  RESULTS
  All reconstituted or infused telavancin solutions met the prespecified stability acceptance criteria after 2 days under ambient and minimum 7 days under refrigeration. Following inoculation with gram-positive and gram-negative microorganisms, telavancin infusion solutions stored under ambient conditions reduced or inhibited populations of all organisms up to 48 hours, except for Serratia marcescens, which exhibited growth of >0.5 log10 after 12 hours. All refrigerated samples inhibited or reduced bacterial populations up to 6 days.
  
  
  CONCLUSIONS
  These results are supportive of a total hold time for reconstituted telavancin in vials plus the time in IV infusion solutions in polyvinyl chloride bags to not exceed 12 hours under ambient conditions and 7 days under refrigeration.
authors: Theravance Biopharma US, Inc, South San Francisco, California.
authors: Zhengtian
authors: Z
authors: Gu
authors: Theravance Biopharma US, Inc, South San Francisco, California.
authors: Carlos
authors: C
authors: Parra
authors: Theravance Biopharma US, Inc, South San Francisco, California.
authors: Anissa
authors: A
authors: Wong
authors: Theravance Biopharma US, Inc, South San Francisco, California.
authors: Alice
authors: A
authors: Nguyen
authors: Theravance Biopharma US, Inc, South San Francisco, California.
authors: Ronnie
authors: R
authors: Cheung
authors: Theravance Biopharma US, Inc, South San Francisco, California.
authors: Thomas
authors: T
authors: Catalano
keywords: infusion; intravenous; reconstitution; stability; telavancin