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Impurity reference standards

Impurity Reference Standards
Impurity reference standards are physical benchmarks for implementing pharmaceutical quality standards. They serve as critical carriers for metrological traceability, acting as specialized tools to assess drug quality, establish measurement baselines, determine drug authenticity and efficacy, and calibrate testing instruments and methodologies. Within national drug standards, they are state-issued reference materials for both quantitative and qualitative analysis of pharmaceuticals.

Primary Functions

  1.Quality Control Applications:
  • Used as standard substances for drug identification, purity testing, and content determination.
  • Function as specialized "measuring tools" that directly impact the accuracy and reproducibility of test results.
  2.Targeted Impurity Control:

  • Essential for increasingly stringent impurity profiling, including localization, quantification, and response factor determination of specific impurities mandated by modern pharmacopeial standards.


Selection Criteria

  1.Source Availability:
  • Common Process-Related Impurities (e.g., by-products) are typically obtainable from pharmacopeial authorities (USP, EP) or certified suppliers (e.g., LGC).
  • Unique or Rare Impurities often require in-house synthesis, extraction, or isolation. Such impurities lack commercially available reference standards and necessitate method development, validation, and calibration to enable accurate quantification in active pharmaceutical ingredients (APIs).
  2.Critical Parameters for Procurement:
  • Purity: The cornerstone of reference standard quality (e.g., ≥98% by HPLC).
  • Shelf Life: Indicates stability under specified storage conditions.
  • Documentation: Complete Certificate of Analysis (COA) and spectral data (e.g., NMR, LC-MS).
  • Supplier Credentials: ISO/IEC 17034 accreditation, GMP compliance, and traceability to international standards.
Hengyuan Fine Chemical’s PCL Impurity Reference Standards
  Hengyuan Fine Chemical supplies PCL-branded impurity reference standards with the following advantages:
  • Full Documentation: Batch-specific COA and spectral data provided.
  • Direct Manufacturing Supply: Eliminates intermediaries, ensuring cost-effectiveness and rapid delivery.
  • Comprehensive Portfolio: Covers a wide range of pharmacopeial and custom-synthesized impurities.
  • Regulatory Readiness: Supports compliance with ICH, USP, and ChP requirements.
Contact us for technical specifications or procurement inquiries.

Product Number Image Product Name CAS No. Molecular Formula
Product Number:PCL-#-Mi651-50mg M4-10 (cabozantinib impurity 38) Product Name:M4-10 (cabozantinib impurity 38) CAS No.:651054-52-3 Molecular Formula:
Product Number:PCL-#-Di190-50mg 4-[(6,7-dimethoxyquinolin-4-yl)oxy]aniline Product Name:4-[(6,7-dimethoxyquinolin-4-yl)oxy]aniline CAS No.:190728-25-7 Molecular Formula:
Product Number:PCL-#-Di217-50mg 1-[[4-[(6,7-dimethoxyquinolin-4-yl)oxy]phenyl]carbamoyl]cyclopropanecarboxylic acid Cabozantinib imp Product Name:1-[[4-[(6,7-dimethoxyquinolin-4-yl)oxy]phenyl]carbamoyl]cyclopropanecarboxylic acid Cabozantinib imp CAS No.:849217-77-2 Molecular Formula:
Product Number:PCL-#-Di849-50mg M4-7 (N-(4-((6,7-dimethoxyquinolin-4-yl)oxy)phenyl)-N-phenylcyclopropane-1,1-dicarboxamide) Product Name:M4-7 (N-(4-((6,7-dimethoxyquinolin-4-yl)oxy)phenyl)-N-phenylcyclopropane-1,1-dicarboxamide) CAS No.:849221-94-9 Molecular Formula:
Product Number:PCL-#-Nf849-50mg Cyclopropane-1,1-dicarboxylic acid N-(4-fluorophenyl)amide N'-(4-hydroxyphenyl)amide Product Name:Cyclopropane-1,1-dicarboxylic acid N-(4-fluorophenyl)amide N'-(4-hydroxyphenyl)amide CAS No.:849217-60-3 Molecular Formula:
Product Number:PCL-#-Mt127-50mg M2-9 Product Name:M2-9 CAS No.:1275738-77-6 Molecular Formula:
Product Number:PCL-#-Fl918-50mg 1-[(2-Fluorophenyl)carbamoyl]cyclopropanecarboxylic acid Product Name:1-[(2-Fluorophenyl)carbamoyl]cyclopropanecarboxylic acid CAS No.:918642-61-2 Molecular Formula:
Product Number:PCL-#-Fl849-50mg M2-7 (M3-1; 1-(4-fluorophenylcarbamoyl)cyclopropanecarboxylic acid) Product Name:M2-7 (M3-1; 1-(4-fluorophenylcarbamoyl)cyclopropanecarboxylic acid) CAS No.:849217-48-7 Molecular Formula:
Product Number:PCL-#-Ca113-50mg M2-5 (cabozantinib impurity 47) Product Name:M2-5 (cabozantinib impurity 47) CAS No.:113136-79-1 Molecular Formula:
Product Number:PCL-#-Ca145-50mg M2-4 (cabozantinib impurity 3) Product Name:M2-4 (cabozantinib impurity 3) CAS No.:145591-80-6 Molecular Formula:
Product Number:PCL-#-Ca143-50mg M2-3 (cabozantinib impurity EXA) Product Name:M2-3 (cabozantinib impurity EXA) CAS No.:1431468-36-8 Molecular Formula:
Product Number:PCL-#-Fl37-50mg 4-fluoroaniline Product Name:4-fluoroaniline CAS No.:371-40-4 Molecular Formula:
Product Number:PCL-#-Cy598-50mg 1,1-Cyclopropanedicarboxylic acid Product Name:1,1-Cyclopropanedicarboxylic acid CAS No.:598-10-7 Molecular Formula:
Product Number:PCL-#-Ch998-50mg 4-Chloro-7,8-dimethoxyquinoline Product Name:4-Chloro-7,8-dimethoxyquinoline CAS No.:99878-79-2 Molecular Formula:
Product Number:PCL-#-Fl134-50mg 4-Hydroxy-6,7-dimethoxyquinoline Product Name:4-Hydroxy-6,7-dimethoxyquinoline CAS No.:13425-93-9 Molecular Formula:
Product Number:PCL-#-Di155-50mg Diethyl 1,1-cyclopropanedicarboxylate Product Name:Diethyl 1,1-cyclopropanedicarboxylate CAS No.:1559-02-0 Molecular Formula:
Product Number:PCL-#-Et369-50mg SM3 (M2-Z6; monoethyl cyclopropyl-1,1-dicarboxylate) Product Name:SM3 (M2-Z6; monoethyl cyclopropyl-1,1-dicarboxylate) CAS No.:3697-66-3 Molecular Formula:
Product Number:PCL-#-Di113-50mg 3,4-Dimethoxyacetophenone Product Name:3,4-Dimethoxyacetophenone CAS No.:1131-62-0 Molecular Formula:
Product Number:PCL-#-Pr129-50mg SM1-1 Product Name:SM1-1 CAS No.:1293935-84-8 Molecular Formula:
Product Number:PCL-#-Me009-25mg Morinidazole impurity G Product Name:Morinidazole impurity G CAS No.:62580-80-7 Molecular Formula:
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