USP-NF Testing of Acetaminophen Batches

This is a source’s sought notice as a means of conducting market research. The USDA APHIS is seeking all interested sources capable of providing U.S. Pharmacopeia-National Formulary (USP-NF) compendial monograph purity and impurities testing of 10 samples of technical acetaminophen (≥98% purity; CAS Number 103-90-2). The USDA APHIS is considering a one-time purchase order to accomplish this need. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 541380 - Testing Laboratories and Services. The size standard for this code is $19,000,000 for determination of small business status. Product Service Code is 6640. The specifications for the product are as follows;

Technical Requirements 

10 (EA) – USP-NF testing of Acetaminophen manufacturing batch

10 (EA) – Certificate of Analysis per batch

Provision of all reference standards required for USP-NF batch testing.

Samples from ten independent manufacturing batches of acetaminophen (≥98% purity; CAS Number 103-90-2), which will be provided by the Government after the contract is issued, must be tested by the contract laboratory for purity and all impurities listed in and in accordance with the current U.S. Pharmacopeia-National Formulary (USP-NF) compendial monograph for acetaminophen. Exception: The standard USP-NF testing of the 10 batches for residual solvents USP <467> is not required.

The testing laboratory’s deliverable will be a Certificate of Analysis for each batch (10 total), which provides the purity and impurities test descriptions and results for that batch.

The testing laboratory must also provide or obtain all USP reference standards required for the current USP-NF compendial monograph testing for acetaminophen as part of this contract.

The testing laboratory must hold ISO 17025 accreditation and offer services for USP-NF compendial testing for active pharmaceutical ingredients (APIs).

This USP-NF compendial monograph testing does not need to meet FDA’s 21 CFR 210/211 requirements or EPA’s FIFRA GLP 40 CFR 160 requirements.

Purpose:

The Government needs to procure the service of U.S. Pharmacopeia-National Formulary (USP-NF) compendial monograph purity and impurities testing of 10 samples of technical acetaminophen (≥98% purity; CAS Number 103-90-2). The Government will provide the 10 acetaminophen samples to the testing laboratory after the contract is issued. Each sample is from a different manufacturing batch (5 batch samples from 2 different manufacturing sources). This testing must be conducted in accordance with all current USP-NF compendial monograph purity and impurities test requirements for acetaminophen.

Acetaminophen is the active ingredient in a pesticide product registered by USDA-APHIS with the Environmental Protection Agency (EPA). The Government is seeking EPA-approval for two new manufacturing sources of acetaminophen for this pesticide product, because the previous registered manufacturing source for the product went out of business. The Government has 5 independent manufacturing batches of acetaminophen from two new manufacturing source (10 batches in total). The USP-NF compendial monograph test results for these 10 manufacturing batches will be used by the Government to apply for EPA approval of these two new manufacturing sources of acetaminophen for a registered pesticide product.

-------------------------------------------------------------------------------------------------------------------------------------

There is no solicitation currently. This is only a source’s sought notice for market research purposes; responses will be used to determine whether this requirement may be set-aside for small business or procured through full and open competition. This request for capability information does not constitute a request for quote; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred.

If you are an interested vendor, please provide the following information:

1) Business name and contact information

2) Business Size and confirmation of registration in SAM.gov by providing your SAM UEI Code

3) Capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of meeting specifications of USP-NF testing and ISO 17025 accreditation.

Electronic responses are required. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

Interested parties who provide this product in accordance with the specifications provided are invited to submit a response to this Sources Sought Notice no later than Wednesday, July 17th, 2024 at 12pm CT. All responses under this Sources Sought Notice must be emailed to Samantha Johnson at, samantha.johnson3@usda.gov.