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Stability and Quality Testing Services

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The contract entails the execution of comprehensive stability studies, potency testing, microbial limits analysis, and dissolution testing in strict accordance with United States Pharmacopeia standards. All testing must be performed on each production batch with full documentation and the delivery of a Certificate of Analysis for every lot to ensure regulatory compliance and product quality. The contractor is also responsible for providing technical support in validating the shelf-life of the product, ensuring that all data collected and analyzed reliably supports the established expiration dating. Performance of all services is required to occur at the designated location in Bristol, Tennessee, with the work being conducted under a subcontract structure for the Department of Health and Human Services through its Aspr/orm-Sns division. The NAICS code 541380 indicates this falls under other scientific and technical consulting services, emphasizing specialized analytical expertise. The solicitation was posted on June 26, 2026, and all deliverables must meet the rigorous requirements of USP guidelines with no deviations permitted, ensuring the integrity and consistency of pharmaceutical quality outcomes.

General Info

Conduct USP-compliant stability and potency testing in Bristol, TN, with Certificate of Analysis for each batch.

NAICS

541380 - Testing Laboratories and Services

Place of Performance

Bristol, TN, 37620, USA

Set-Aside

NONE

Documents

This scope was carved out of 75A50326F80004-Justification.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Post Award Justification - Amoxicillin trihydrate 500mg Oral Capsules

AI Contract Breakdown

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Timeline

Posted

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Aspr/orm-Sns
ContactsNo contacts available
OfficeN/A
Office AddressN/A
ContactsNo contact information available

Full Description

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Conduct stability studies, potency testing, microbial limits, and dissolution testing per USP standards. Provide Certificates of Analysis (CoA) for each batch and support shelf-life validation.

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