Fat emulsion pyrogenicity test

• US 4,245,044 A
• Filed: 02/01/1979
• Issued: 01/13/1981
• Est. Priority Date: 02/01/1979
• Status: Expired due to Term

• Current Assignee: Cutter Laboratories, Inc. (Bayer AG)
• Original Assignee: Cutter Laboratories, Inc. (Bayer AG)
• Inventors: Thompson, Charles R., Kuo, Harng-Shen, Mutha, Shantilal C.
• Primary Examiner(s): Wyse, Thomas G.
• Application Number:
  US06/008,462
• Time in Patent Office: 712 Days
• Field of Search: 435/34, 23/230 B, 252/408, 424/12, 424/101
• US Class Current: 435/18
• CPC Class Codes: G01N 33/579 involving limulus lysate

Abstract

Low concentration pyrogens in fat emulsions can be determined by using Limulus lysate test procedures. A preferred lysate was observed to have a relatively low calcium ion concentration.

Claims

1. A method of testing for the presence of pyrogens in an aqueous fat emulsion intended for intraveneous administration which comprises incubating the fat emulsion with a Limulus lysate solution under conditions sufficient to effect gelation of at least some lysate constituents if pyrogens are present in the aqueous fat emulsion at a predetermined concentration.

2. The method of claim 1 wherein the pyrogen is E. coli endotoxin at a predetermined concentration at least as low as about 0.12 ng/ml of aqueous fat emulsion.

3. The method of claim 2 wheren the predetermined concentration of pyrogen is at least as low as about 0.06 ng/ml.

4. The method of claim 3 wherein the predetermined concentration of pyrogen is at least as low as about 0.03 ng/ml.

5. The method of claim 1 wherein the incubation conditions are at a temperature of 37°

±

1°

C. for about 60 minutes.

6. The method of claim 1 wherein the concentration of calcium ions is approximately that concentration found naturally in amebocyte cells from which the lysate is prepared.

7. The method of claim 1 wherein, prior to incubation with the lysate, the majority of the fat emulsion is separated from the aqueous emulsion to result in a substantially aqueous remaining portion which portion is then incubated with the lysate.