Sulindac Impurity 3: A Reference Standard for NSAID Drug Quality Control

 Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute gout. As a prodrug that is metabolized in the body to its active sulfide form, Sulindac has a chemically nuanced structure, which makes careful impurity profiling essential during manufacturing. Sulindac Impurity 3 is one of the reference materials that supports this work.

What Is Sulindac Impurity 3?

Sulindac Impurity 3 is chemically identified as 6-Fluoro-2-methyl-2,3-dihydro-1H-inden-1-one, a fluorinated indanone compound relevant to the Sulindac synthetic pathway. Because it is structurally related to the core ring system of the drug, it requires precise analytical separation from Sulindac during quality testing.

Key specifications:

  • CAT No: SZ-S060008
  • CAS No: 37794-19-7
  • Molecular Formula: C10H9FO
  • Molecular Weight: 164.2
  • Availability: Synthesis on demand
  • Shipping Condition: Ambient temperature

Why This Standard Matters in Sulindac Manufacturing

Reference standards like Sulindac Impurity 3 are indispensable for laboratories working on Sulindac generics 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 Sulindac 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 Sulindac 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 Sulindac Impurity 3

SynZeal's Sulindac Impurity 3 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. As with all SynZeal reference materials, it is intended strictly for laboratory, research, and analytical use, not for human consumption.

It is part of a broader Sulindac-related impurity series that includes the parent Sulindac standard, Sulindac EP Impurities A through D, Sulindac Impurities 1 and 2, Sulindac Sulfone Methyl Ester, and Phospho-sulindac, which is useful for labs building a complete impurity library for this long-established NSAID.

Explore More

For labs working across anti-inflammatory and other 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.

Comments

Post a Comment

Popular posts from this blog

The Crucial Role of Reference Standards in the Pharmaceutical Industry

Image
  Introduction In modern pharmaceutical research, accuracy isn’t optional—it’s essential. Every Active Pharmaceutical Ingredient (API) and every formulation depends on precise analytical testing. This is where reference standards play a critical role. These highly purified compounds serve as measurement benchmarks, ensuring that every analytical result is consistent, reliable, and compliant with global regulatory expectations. Among global providers, SynZeal Research has emerged as a trusted partner supplying high-quality impurity standards, reference standards, metabolites, and custom synthesis materials to support consistent analytical performance from R&D to regulatory submission. Why Reference Standards Matter in Pharma 1. Ensuring Accurate API Identification Pharmaceutical companies rely on reference standards to confirm the identity of APIs and impurities using techniques like HPLC, GC, LC-MS, NMR, and IR. A high-purity standard ensures that analytical teams can verify e...
Read more

Pharmaceutical Reference Standards: A Complete Guide by SynZeal

Image
  In modern pharmaceutical research and quality control, pharmaceutical reference standards are foundational tools that ensure accurate, consistent, and compliant analytical results. At SynZeal , we specialize in delivering high-purity reference materials — including APIs, impurity standards, metabolites, isotopically labelled compounds and custom reference standards — to support global drug development and regulatory testing workflows. What Are Pharmaceutical Reference Standards? A pharmaceutical reference standard is a well-characterized, highly purified material used as a benchmark for testing the identity, strength, quality, and purity of drug substances, excipients and finished products. These standards are essential in analytical method development, quality control testing, and regulatory submissions. Reference standards can be sourced from national or international pharmacopeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or developed in-ho...
Read more

Impurity Reference Standards Across Therapeutic Areas: What Analytical Labs Need to Know

Image
  Impurity profiling looks different depending on which drug class you're testing. A diabetes drug, a statin, and an anticoagulant each carry their own set of process-related impurities, degradation products, and pharmacopeial (USP/EP) related compounds. Having the right, well-characterized reference standard for each is what actually makes a validated analytical method possible. Here's a practical look at three real examples spanning three major therapeutic categories — and why sourcing the correct reference standard matters more than it might seem. Quick Reference: The Three Impurities at a Glance Therapeutic Area Drug Impurity CAS No. Diabetes (SGLT2 inhibitor) Dapagliflozin Hydroxy Dapagliflozin (USP) 1204222-85-4 Cardiovascular (Statin) Pravastatin EP Impurity A (6′-Epipravastatin) 81176-41-2 Anticoagulant Dabigatran Etexilate Despyridyl Ethyl Ester 1408238-36-7 Diabetes: Dapagliflozin and Its Impurity Profile Dapagliflozin is an SGLT2 inhibitor widely used in ...
Read more