23-001005

Post Date/ Solicitation Issue Date

November 21, 2022 12:00 pm

Closing Response Date

December 1, 2022 10:01 am

Proposed Award Date

December 5, 2022 12:00 pm

Project Title

D-GLUCOSE (U-13C6, 99%) MICROBIOLOGICAL/PYROGEN TESTED

Contracting Office

National Institute of Mental Health (NIMH)

Small Business Size Standard

n/a

FPDS Classification Code

6505

Delivery of Goods

4 weeks ARO

Competition Status

Non-Competitive

Single-Sole Source Determination

The [U-13C6]glucose listed herein is available from only one source, and competition is precluded for the reasons indicated below. There are no substitutes available.


Brand-name or Items peculiar to one manufacturer:
[U-13C6]glucose is used in the form of 20% solution. The solution is prepared at NIH Pharmacy. Recently, NIH Pharmacy has established a new set of testing criteria for tighter quality control of all isotopes. The details of the testing criteria can be found in the document of Purchase Description, section 5. At this time, NIH Pharmacy has only worked out the agreement with Cambridge Isotope Laboratories, Inc. to fully implement all NIH testing procedures. Thus, Cambridge Isotope Laboratories, Inc. is the sole source that we can purchase the material from.

Background/Description of Requirement

Stable isotopes have been used safely in clinical research for decades and have contributed insights into human metabolism. Magnetic Resonance Spectroscopy (MRS) Section and Core have been conducting research projects using carbon-13 (¹³C) labeled glucose to study brain metabolism of healthy volunteers for more than ten years.

Common MRS detect signals from protons which are dominant nuclei in living tissues. ¹³C MRS detects signals of carbons instead of protons which provides different information of metabolism.

Because natural abundance of ¹³C is only one percent, signals from natural ¹³C is too weak to be detected. Thus, we need to administrate ¹³C enriched chemicals into human subjects to increase ¹³C signal intensity.

In an ongoing project, [U-¹³C₆] glucose will be used. The glucose will be prepared into 20% solution for oral administration. Each human study will use 40-50 grams of [U-¹³C₆] glucose depending on the body weight of the subject. With the administration of ¹³C labeled glucose, we should be able to measure ¹³C signals in a reasonable scan time.

The objective for this procurement is to purchase 120 gm of [U-¹³C₆]glucose. The manufacture should produce the isotope product and ship the product to the NIH Clinical Center Pharmacy after microbial and analytical testing.

 

Salient Characteristics:

Intended for nonsterile / oral use (Raw)

Must have a lot specific Certificate of Analysis (COA)

COA must contain the following information: Lot number Identity Chemical purity Appearance / odor Isotopic enrichment Impurity profile with total percent of heavy metals   Statement that material is not derived from   animal/human source or Bovine Spongiform Encephalopathy / Transmissible Spongiform Encephalopathy testing results All test results shall meet or exceed the vendor’s published specifications Raw material (for non-sterile use) can be the finished product if the research indication is appropriate for its use. Meet USP <1111> standards for non-sterile   drugs – (for microbial enumeration (that includes Total Aerobic Microbial Count / Total Combined Yeast/Molds Count) and absence of Escherichia coli)