Ivacaftor Impurity 8: A Reference Standard for Cystic Fibrosis Drug Quality Control

Ivacaftor is a CFTR potentiator used to treat cystic fibrosis (CF) in patients with specific gene mutations — a precision medicine that has transformed disease management for eligible patients. As a targeted therapy taken chronically by a defined patient population, its manufacturing quality standards are held to the same rigor as any long-term maintenance drug, with every process-related impurity carefully mapped, characterized, and controlled. Ivacaftor Impurity 8 is part of that impurity library.

What Is Ivacaftor Impurity 8?

Ivacaftor Impurity 8 is chemically identified as 5-Amino-2,4-di-tert-butylphenyl methyl carbonate — a process-related impurity relevant to Ivacaftor manufacturing that requires precise analytical separation from the parent drug during quality testing.

Key specifications:

  • CAT No: SZ-I015010
  • CAS No: 1182822-31-6
  • Molecular Formula: C16H25NO3
  • Molecular Weight: 279.4
  • Availability: In Stock
  • Shipping Condition: Room temperature

Why This Standard Matters in Ivacaftor Manufacturing

Reference standards like Ivacaftor Impurity 8 are indispensable for laboratories working on Ivacaftor generics, combination products, or new formulations. Specifically, they support:

  • Analytical method development and validation (AMV) — ensuring HPLC/LC-MS methods can reliably detect and separate this impurity from Ivacaftor itself
  • Quality control (QC) testing — confirming batch purity during commercial production
  • ANDA filing support — providing the authentic reference material regulators expect for submission dossiers
  • Forced degradation studies — helping labs understand how Ivacaftor behaves and breaks down under stress conditions
  • Unknown impurity identification — serving as a match standard when unexpected peaks appear during routine analysis
  • DMF filing support — supplying the documented reference material regulators expect in submission dossiers

Sourcing Ivacaftor Impurity 8

SynZeal's Ivacaftor Impurity 8 reference standard is supplied with detailed characterization data compliant with regulatory guidelines, and traceability against USP or EP pharmacopeial standards can be provided based on feasibility. It's also available with an SDS for lab safety handling requirements. As with all SynZeal reference materials, it is intended strictly for laboratory, research, and analytical use — not for human consumption.

It's part of a broader Ivacaftor-related impurity series that includes the parent compound, Ivacaftor Carboxylic Acid, Impurities 1 through 7, the Ivacaftor Ortho Isomer, Ivacaftor Methylcarbonate, Ivacaftor Amine Impurity, the Ivacaftor Nitro Phenol Impurity, and De-Alkylated Ivacaftor — useful for labs building a complete impurity library for this widely used CFTR modulator.

Explore More

For labs working across cystic fibrosis and other specialty therapeutic areas, it's worth browsing the full SynZeal product catalog, which spans thousands of pharmacopeial and non-pharmacopeial reference standards, metabolites, and stable isotope-labelled compounds across major therapeutic categories.

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