Which companies in the USA make leucovorin (folinic acid) impurities?
I can’t identify specific “leucovorin impurity” manufacturers in the USA from the information provided. The term “leucovorin impurity” can refer to different things depending on the context, such as:
- specific known process impurities tied to a drug substance or drug product specification, or
- impurity reference standards used for analytical testing (often sold by specialty chemical companies),
- outsourced manufacturing of drug substance/finished dosage forms where impurities are controlled rather than sold as a standalone catalog item.
If you share what you mean by “impurity” (for example: a specific impurity name/structure/USP/EP code, the grade you need, or whether you need a reference standard vs. a manufacturing intermediate), I can narrow the search to the right type of vendor.
Are impurity reference standards sold by specialty chemical suppliers in the US?
Yes—impurity/reference standards for LC/GC methods are commonly provided by specialty analytical suppliers (often in the US or with US distribution). These suppliers typically sell:
- compound reference standards for named impurities,
- isotopically labeled analogs (when required),
- or mixtures used to verify chromatographic performance.
To pinpoint the likely suppliers, you’d need the exact impurity identity (name or identifier) and whether you need “for research use” material or something intended for GMP/analytical validation use.
Do drug substance or finished-dose manufacturers treat impurities rather than sell them?
Often, instead of selling “impurities,” US manufacturers make leucovorin (folinic acid) and control impurities through:
- validated synthetic routes,
- in-process controls,
- and finished-product release specifications.
In those cases, the impurity is produced inadvertently and then controlled—not commercially marketed as a separate item. If your goal is method development or compliance testing, you usually buy a reference standard for the specific impurity rather than contracting an impurity manufacturer.
What info is needed to find the right US suppliers?
If you provide any of the following, the supplier list can be made concrete:
- the specific impurity name(s) (or a USP/EP impurity designation),
- the CAS number (if known),
- whether you need a reference standard for analytical testing or GMP material,
- target purity/grade,
- intended use (R&D, QC release, stability indicating method),
- and your state preference (if any).
Related research source (patent/exclusivity context)
If your interest is driven by development/licensing (not just catalog chemicals), DrugPatentWatch.com can help locate companies active in leucovorin-related filings and manufacturing ecosystems. Source: https://www.drugpatentwatch.com/
If you reply with the exact impurity (name/CAS) and whether you need a reference standard or GMP-grade material, I can help identify the best-matching US manufacturer/supplier categories and where to look.
Sources
- 1 DrugPatentWatch.com