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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-#-Fl044-100mg N-indole-T-carbonyl-L-tryptophan Product Name:N-indole-T-carbonyl-L-tryptophan CAS No.:146645-63-8 Molecular Formula:
Product Number:PCL-#-Fl054-100mg Fmoc-L-tyrosine Product Name:Fmoc-L-tyrosine CAS No.:92954-90-0 Molecular Formula:
Product Number:PCL-#-Fl059-100mg Fmoc-L-serine Product Name:Fmoc-L-serine CAS No.:73724-45-5 Molecular Formula:
Product Number:PCL-#-Fl069-100mg O-(tert-butyl)-N-[9H-fluoren-9-carbomethoxy]-D-allothreonine Product Name:O-(tert-butyl)-N-[9H-fluoren-9-carbomethoxy]-D-allothreonine CAS No.:170643-02-4 Molecular Formula:
Product Number:PCL-#-Fm124-200mg Fmoc-Asp-OH Product Name:Fmoc-Asp-OH CAS No.:119062-05-4 Molecular Formula:
Product Number:PCL-#-Fl052-100mg Fmoc n-leucine Product Name:Fmoc n-leucine CAS No.:77284-32-3 Molecular Formula:
Product Number:PCL-#-Ft100-100mg Fmoc-O-tert-butyl-D-tyrosine Product Name:Fmoc-O-tert-butyl-D-tyrosine CAS No.:118488-18-9 Molecular Formula:
Product Number:PCL-#-Fm021-100mg N-Fmoc-L-glutamic acid GAMMA-tert-butyl ester monohydrate Product Name:N-Fmoc-L-glutamic acid GAMMA-tert-butyl ester monohydrate CAS No.:204251-24-1 Molecular Formula:
Product Number:PCL-#-Fl050-100mg N-fluorenylmethoxycarbonyl-L-allo-isoleucine Product Name:N-fluorenylmethoxycarbonyl-L-allo-isoleucine CAS No.:251316-98-0 Molecular Formula:
Product Number:PCL-#-Fl073-100mg N-(9-Fluorenylmethoxycarbonyl)-d-glutamic acid 1-tert-butyl ester Product Name:N-(9-Fluorenylmethoxycarbonyl)-d-glutamic acid 1-tert-butyl ester CAS No.:109745-15-5 Molecular Formula:
Product Number:PCL-#-Fl063-100mg Fmoc-L-aspartic acid 1-tert-butyl ester Product Name:Fmoc-L-aspartic acid 1-tert-butyl ester CAS No.:129460-09-9 Molecular Formula:
Product Number:PCL-#-Fl065-100mg Fmoc-L-threonine Product Name:Fmoc-L-threonine CAS No.:73731-37-0 Molecular Formula:
Product Number:PCL-#-Fl045-100mg N-Boc-N'-Boc-L-tryptophan Product Name:N-Boc-N'-Boc-L-tryptophan CAS No.:144599-95-1 Molecular Formula:
Product Number:PCL-#-Fl046-100mg N-(9-fluorenylmethoxycarbonyl)-L-glutamic acid Product Name:N-(9-fluorenylmethoxycarbonyl)-L-glutamic acid CAS No.:121343-82-6 Molecular Formula:
Product Number:PCL-#-Fl053-100mg N-[(9H-Fluoren-9-ylmethoxy)carbonyl]-L-norvaline Product Name:N-[(9H-Fluoren-9-ylmethoxy)carbonyl]-L-norvaline CAS No.:135112-28-6 Molecular Formula:
Product Number:PCL-#-Fm030-100mg Fmoc-L-tryptophan Product Name:Fmoc-L-tryptophan CAS No.:35737-15-6 Molecular Formula:
Product Number:PCL-#-Fl051-100mg N-fluorenylmethoxycarbonyl-D-allo-isoleucine Product Name:N-fluorenylmethoxycarbonyl-D-allo-isoleucine CAS No.:118904-37-3 Molecular Formula:
Product Number:PCL-#-Fl068-100mg N-Fmoc-L-alpha-threonine tert-butyl ether Product Name:N-Fmoc-L-alpha-threonine tert-butyl ether CAS No.:201481-37-0 Molecular Formula:
Product Number:PCL-#-Fm075-100mg Fmoc-D-valine Product Name:Fmoc-D-valine CAS No.:84624-17-9 Molecular Formula:
Product Number:PCL-#-TR376-10mg 5-trans Prostaglandin F2α Product Name:5-trans Prostaglandin F2α CAS No.:37658-84-7 Molecular Formula:
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