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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-#-Ur004-25mg Urapidil Impurity IV Product Name:Urapidil Impurity IV CAS No.:769-42-6 Molecular Formula:
Product Number:PCL-#-Ur007-100mg Urapidil impurity VII Product Name:Urapidil impurity VII CAS No.:108997-11-1 Molecular Formula:
Product Number:PCL-#-Ur006-25mg Urapidil impurity VI Product Name:Urapidil impurity VI CAS No.:35386-24-4 Molecular Formula:
Product Number:PCL-#-Ur002-50mg Urapidil impurity II Product Name:Urapidil impurity II CAS No.:91453-03-1 Molecular Formula:
Product Number:PCL-#-Ur008-50mg Urapidil impurity VIII Product Name:Urapidil impurity VIII CAS No.:34654-80-3 Molecular Formula:
Product Number:PCL-#-Ur005-150mg Urapidil Impurity V Product Name:Urapidil Impurity V CAS No.:20529-23-1 Molecular Formula:
Product Number:PCL-#-Ur001-50mg Urapidil impurity I Product Name:Urapidil impurity I CAS No.:34654-81-4 Molecular Formula:
Product Number:PCL-#-Ur003-50mg Urapidil impurity III Product Name:Urapidil impurity III CAS No.:34661-73-9 Molecular Formula:
Product Number:PCL-#-Li403-50mg Lithium bis(trimethylsilyl)amine Product Name:Lithium bis(trimethylsilyl)amine CAS No.:4039-32-1 Molecular Formula:
Product Number:PCL-#-Nc025-50mg N-nitroso-ciprofloxacin Product Name:N-nitroso-ciprofloxacin CAS No.:864443-44-7 Molecular Formula:
Product Number:PCL-#-Yx765-100mg 2-chloro-5-methyl-4-nitropyridine-N-oxide Product Name:2-chloro-5-methyl-4-nitropyridine-N-oxide CAS No.:60323-96-8 Molecular Formula:
Product Number:PCL-#-Ax765-100mg 2-chloro-4-amino-5-methylpyridine Product Name:2-chloro-4-amino-5-methylpyridine CAS No.:79055-62-2 Molecular Formula:
Product Number:PCL-#-Fi055-25mg Fenelidone impurity 8 (intermediate FNLT-4) Product Name:Fenelidone impurity 8 (intermediate FNLT-4) CAS No.:1050477-45-6 Molecular Formula:
Product Number:PCL-#-Fi034-50mg Fenelidone impurity GT0001-1A Product Name:Fenelidone impurity GT0001-1A CAS No.:914106-35-7 Molecular Formula:
Product Number:PCL-#-Fi035-100mg 4-Cyano-2-methoxybenzaldehyde Product Name:4-Cyano-2-methoxybenzaldehyde CAS No.:21962-45-8 Molecular Formula:
Product Number:PCL-#-Fi057-25mg Fenelidone impurity 10 (intermediate FNLT-6) Product Name:Fenelidone impurity 10 (intermediate FNLT-6) CAS No.:1050477-43-4 Molecular Formula:
Product Number:PCL-#-Fi048-100mg Fenelidone impurity GT0001-3-E formula Product Name:Fenelidone impurity GT0001-3-E formula CAS No.:1870824-79-5 Molecular Formula:
Product Number:PCL-#-Fi036-50mg 4-amino-5-methyl-2-hydroxypyridine Product Name:4-amino-5-methyl-2-hydroxypyridine CAS No.:95306-64-2 Molecular Formula:
Product Number:PCL-#-Chp0401-100mg Isepamicin sulfate impurity II (Gentamicin B) O-6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)-O-[3-deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)]-2-deoxy-D-streptamine Product Name:Isepamicin sulfate impurity II (Gentamicin B) O-6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)-O-[3-deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)]-2-deoxy-D-streptamine CAS No.:36889-15-3 Molecular Formula:
Product Number:PCL-#-Nm324-50mg N-Methyl Loratadine Product Name:N-Methyl Loratadine CAS No.:38092-89-6 Molecular Formula:
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