Isoconazole Nitrate – Impurity B (CAS 1305320-62-0): A Key Reference Standard in Pharma

What Is It?

Isoconazole Nitrate – Impurity B, catalogued as PA 09 18020, is a defined chemical standard used in pharmaceutical reference and analytical contexts. Its chemical identity is described as (2RS)-2-[(2,6-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethanamine, with a CAS number of 1305320-62-0. The compound has the molecular formula C₁₅H₁₃Cl₄NO and a molecular weight of 365.08 g/mol

Why It Matters

Impurities like this are critical in drug synthesis and quality assessment. They serve as markers or benchmarks during method validation, impurity profiling, and regulatory compliance workflows. Pharmaceutical manufacturers and analytical labs rely on these reference substances to ensure drug safety, purity, and adherence to pharmacopoeial standards.

Storage & Handling Essentials

Maintaining the stability of this impurity is vital. Recommended storage conditions include refrigeration at 2–8 °C, while shipment can occur under ambient conditions—a balance between practicality and preservation.

Isoconazole Nitrate – Impurity B (CAS 1305320-62-0): A Key Reference Standard in Pharma


Role in Pharmaceutical Research & Development

  • Analytical Precision: As a reference standard, it enhances the accuracy of techniques like chromatography, spectroscopy, and method validation.
  • Regulatory Alignment: It supports compliance with pharmacopeial guidelines (EP/BP), playing a role in dossier preparation and regulatory submissions.
  • Broader Context: This impurity is part of a panel that includes related compounds like Impurity A and C—each representing different transformation or degradation outcomes of the parent drug Isoconazole Nitrate.

How It Compares

While this impurity is essential for analytical rigor, it's different from Isoconazole Nitrate – Impurity B (Nitrate Salt)—catalogued under PA 09 0180021 with a distinct CAS 2726492-80-2, molecular formula C₁₅H₁₄Cl₄N₂O₄, and molecular weight 428.09 g/mol PharmaffiliatesVeeprho. Knowing these distinctions is vital for selecting the appropriate standard in experimental and regulatory settings.

Summary Table: Quick Reference

Attribute

Details

Compound Name

Isoconazole Nitrate – Impurity B (Free Base)

CAS Number

1305320-62-0

Molecular Formula/Weight

C₁₅H₁₃Cl₄NO / 365.08 g/mol

Chemical Name

(2RS)-2-[(2,6-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethanamine

Storage

2–8 °C (Refrigerated)

Shipping Conditions

Ambient

Applications

Analytical standards, impurity profiling, method validation, regulatory submission

Related Impurity

Nitrate salt form (CAS 2726492-80-2) with higher molecular weight

So,

This impurity plays an indispensable role in ensuring pharmaceutical quality and compliance. By using well-defined standards like this, laboratories enhance reproducibility, uphold regulatory frameworks, and contribute to safer therapeutic development.

If you'd like guidance on sourcing, analytical methods, or integration into impurity monitoring protocols—just let me know! or visit.

 

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