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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-#-Di185-25mg Cabazitaxel Impurity CI-23 Product Name:Cabazitaxel Impurity CI-23 CAS No.:1420767-25-4 Molecular Formula:
Product Number:PCL-#-Di183-25mg Cabazitaxel impurity ZJT1 Product Name:Cabazitaxel impurity ZJT1 CAS No.:183133-94-0 Molecular Formula:
Product Number:PCL-#-Ni112-25mg Nilotinib chloroform Product Name:Nilotinib chloroform CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Na108-25mg Nafurafine impurity 8 (impurity A502S-Z8) Product Name:Nafurafine impurity 8 (impurity A502S-Z8) CAS No.:152658-36-1 Molecular Formula:
Product Number:PCL-#-Na107-25mg Nafurafine impurity 7 (impurity A502S-Z7) Product Name:Nafurafine impurity 7 (impurity A502S-Z7) CAS No.:163712-68-3 Molecular Formula:
Product Number:PCL-#-Di377-100mg Disodium phenyldibenzimidazole tetrasulfonate Product Name:Disodium phenyldibenzimidazole tetrasulfonate CAS No.:180898-37-7 Molecular Formula:
Product Number:PCL-#-De043-50mg N-Desmethylzopiclone Product Name:N-Desmethylzopiclone CAS No.:300701-71-7 Molecular Formula:
Product Number:PCL-#-Os191-100mg Omeprazole isomers Product Name:Omeprazole isomers CAS No.:161796-77-6 Molecular Formula:
Product Number:PCL-#-Vo082-100mg Vonorazan fumarate impurity 6 Product Name:Vonorazan fumarate impurity 6 CAS No.:2250243-23-1 Molecular Formula:
Product Number:PCL-#-Di088-100mg 2,3-Dichloroaniline Product Name:2,3-Dichloroaniline CAS No.:608-27-5 Molecular Formula:
Product Number:PCL-#-Pr121-10mg Promethazine impurity 17 Product Name:Promethazine impurity 17 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Di099-1g Dexamethasone sodium Product Name:Dexamethasone sodium CAS No.:16208-51-8 Molecular Formula:
Product Number:PCL-#-Es009-50mg Escitalopram impurity G Product Name:Escitalopram impurity G CAS No.:1440961-12-5 Molecular Formula:
Product Number:PCL-#-Mh12-100mg Amlodipine impurities Product Name:Amlodipine impurities CAS No.:19532-97-9 Molecular Formula:
Product Number:PCL-#-Ni099-25mg The 5-position methyl isomer of nilotinib Product Name:The 5-position methyl isomer of nilotinib CAS No.:641571-15-5 Molecular Formula:
Product Number:PCL-#-Ni096-25mg Nilotinib ethyl congener Product Name:Nilotinib ethyl congener CAS No.:2119583-24-1 Molecular Formula:
Product Number:PCL-#-Is017-1ml Isopropyl chloroformate Product Name:Isopropyl chloroformate CAS No.:108-23-6 Molecular Formula:
Product Number:PCL-#-Di056-100mg Diisopropyl carbonate Product Name:Diisopropyl carbonate CAS No.:6482-34-4 Molecular Formula:
Product Number:PCL-#-Is008-120mg sec-butylphthalide Product Name:sec-butylphthalide CAS No.:261783-87-3 Molecular Formula:
Product Number:PCL-#-Ni078-100mg Nilotinib impurity SM02- 1 Product Name:Nilotinib impurity SM02- 1 CAS No.:859026-97-4 Molecular Formula:
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