Which US companies manufacture phenyl butyrate (and likely handle impurities too)?
The term “phenyl butyrate impurity” can refer to either (1) a specific impurity chemical related to phenylbutyrate drug substance/drug product testing, or (2) any impurity generated during synthesis/handling of phenylbutyrate. Because of that ambiguity, the most reliable way to find US manufacturers is to identify the exact impurity name (or CAS number) you need, then search for US suppliers of that particular building block/intermediate.
If you tell me the impurity’s chemical name or CAS (or paste a typical impurity table from a COA/spec), I can narrow to manufacturers/suppliers in the US for that specific substance.
If you mean phenylbutyrate itself: who supplies it in the US?
Many US buyers source phenylbutyrate (API or intermediate) from:
- US chemical manufacturers (specialty/industrial chemicals)
- Contract manufacturers that produce APIs and intermediates for pharma supply chains
- Catalog chemical suppliers that also provide analytical-grade material
To pinpoint companies, you typically need at least the grade (USP/EP, analytical reference standard, pharma-grade API, or intermediate) and intended use (R&D reference vs. GMP release).
How to find “impurity reference standards” in the US
For impurity work (HPLC/LC-MS method development, specification setting), suppliers commonly provide impurity reference standards rather than “impurities” as an off-the-shelf category. In practice, buyers search by:
- “impurity standard” + the parent drug name + impurity name/CAS
- “analytical reference standard” + impurity identifier
- “GMP impurity” + CAS (if you need clinical/regulatory-grade material)
Reference standards are often sold by specialty analytical reagent suppliers, including those with US distribution.
What if you need GMP vs. analytical grade impurity material?
US procurement depends heavily on grade requirements:
- Analytical grade/reference standard: usually for method development and routine lab controls.
- GMP grade: required if the impurity material is used in manufacturing support, stability programs, or regulatory submissions.
If you need GMP, ask suppliers whether they can provide documentation such as CoA, GMP statement/DMF/quality agreements, and batch traceability.
What details would let me give a targeted US manufacturer list?
Reply with any of the following, and I’ll narrow to the most relevant US manufacturers/suppliers:
1. The exact impurity name (as written in your report/spec) and/or CAS number
2. Parent compound: phenylbutyrate (confirm spelling) vs. any other “phenyl butyrate” related chemical
3. Required grade: analytical reference standard, USP/EP, or GMP
4. Quantity and intended use (R&D vs. regulatory/clinical)
Sources
No sources were provided in the prompt, so I can’t cite specific US manufacturers yet.