1-benzyl-4-hydroxy-2-methyl-1H-benzo[d]imidazole-6-carboxylic acid

1‑Benzyl‑4‑hydroxy‑2‑methyl‑1H‑benzo[d]imidazole‑6‑carboxylic acid is a key intermediate and impurity reference standard in the industrial synthesis of tegoprazan, a novel P‑CAB indicated for GERD and erosive oesophagitis. The benzimidazole core of 1‑Benzyl‑4‑hydroxy‑2‑methyl‑1H‑benzo[d]imidazole‑6‑carboxylic acid provides the essential heterocyclic framework for tegoprazan‘s pharmacological activity. In quality control contexts, 1‑Benzyl‑4‑hydroxy‑2‑methyl‑1H‑benzo[d]imidazole‑6‑carboxylic acid is officially designated as Tegoprazan Impurity 4, making it an indispensable analytical reference standard for impurity profiling, analytical method development, method validation, QC testing, and ANDA filings for generic tegoprazan manufacturers. The carboxylic acid group of 1‑Benzyl‑4‑hydroxy‑2‑methyl‑1H‑benzo[d]imidazole‑6‑carboxylic acid enables further derivatisation to amides, esters, and other functional groups, expanding its utility in medicinal chemistry and process development. Because of its dual role, 1‑Benzyl‑4‑hydroxy‑2‑methyl‑1H‑benzo[d]imidazole‑6‑carboxylic acid is available in multiple grades to suit both synthesis and analytical needs.

Product Parameters

Why Cosperpharm?

Precision for impurity profiling. As Tegoprazan Impurity 4, this compound is a mandatory reference standard for analytical method validation. Our reference‑grade product includes comprehensive characterisation data—NMR, HPLC, and mass spectrometry—to support your regulatory submission.

Documentation that supports ANDA filings. Every reference‑grade shipment includes a COA with batch‑specific purity, chromatographic traceability, and characterisation data—structured for direct insertion into your method validation package. Stability summaries and custom quality agreements are available upon request.

Dual‑use intermediate and impurity standard. Supplied at multiple quality levels—as a synthetic intermediate and as Impurity 4 for QC testing.

Regulatory expertise. Our team understands the specific requirements for impurity reference standards in ANDA filings and can provide the documentation you need.

Product Advantages

Comprehensive characterisation – Reference‑grade product includes NMR, HPLC, MS data.

Dual‑use – Serves as both intermediate and impurity standard.

Versatile functionalisation – Carboxylic acid enables derivatisation to amides, esters, etc

Product Quality Assurance

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