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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-#-Ph014-20mg 2,6-Dichlorophenol (EP Impurity I) Product Name:2,6-Dichlorophenol (EP Impurity I) CAS No.:87-65-0 Molecular Formula:
Product Number:PCL-#-Ch657-25mg 1-methylpentyl chloroformate Product Name:1-methylpentyl chloroformate CAS No.:265659-62-9 Molecular Formula:
Product Number:PCL-#-Me149-25mg 4-Methylpiperazine-1-carbonyl chloride hydrochloride Product Name:4-Methylpiperazine-1-carbonyl chloride hydrochloride CAS No.:55112-42-0 Molecular Formula:
Product Number:PCL-#-Fl019-100mg 2'-Fluoroacetophenone Product Name:2'-Fluoroacetophenone CAS No.:445-27-2 Molecular Formula:
Product Number:PCL-#- CB825-1ml di-ethylene phthalate Product Name:di-ethylene phthalate CAS No.:84-75-3 Molecular Formula:
Product Number:PCL-#-C1364-25mg Ursodeoxycholic acid EP impurity B; 3α,7α,12α-trihydroxy-5β-bilirubin-24-oleic acid (bile acid) Product Name:Ursodeoxycholic acid EP impurity B; 3α,7α,12α-trihydroxy-5β-bilirubin-24-oleic acid (bile acid) CAS No.:81-25-4 Molecular Formula:
Product Number:PCL-#-Di0391-500mg o-Phenylenediamine; o-Phenylenediamine Product Name:o-Phenylenediamine; o-Phenylenediamine CAS No.:95-54-5 Molecular Formula:
Product Number:PCL-#-Hi010-20mg Histamine Product Name:Histamine CAS No.:51-45-6 Molecular Formula:
Product Number:PCL-#-Pr041-100mg Pramoxine hydrochloride Product Name:Pramoxine hydrochloride CAS No.:637-58-1 Molecular Formula:
Product Number:PCL-#-Ph009-20mg 1,2,4-Benzenetriol (EP impurity E) Product Name:1,2,4-Benzenetriol (EP impurity E) CAS No.:533-73-3 Molecular Formula:
Product Number:PCL-#-Mi000-100mg Mirabelon Product Name:Mirabelon CAS No.:223673-61-8 Molecular Formula:
Product Number:PCL-#-Pr1081-25mg Propofol impurity EP Product Name:Propofol impurity EP CAS No.:2416-95-7 Molecular Formula:
Product Number:PCL-#- Em118-20mg ethyl maltol Product Name:ethyl maltol CAS No.:4940-11-8 Molecular Formula:
Product Number:PCL-#-Am098-25mg Isoniazid impurity 6 Product Name:Isoniazid impurity 6 CAS No.:38634-05-8 Molecular Formula:
Product Number:PCL-#-Te105-10ml tert-butyl alcohol Product Name:tert-butyl alcohol CAS No.:75-65-0 Molecular Formula:
Product Number:PCL-#-Ab008-20mg 3-bromopropene Product Name:3-bromopropene CAS No.:106-95-6 Molecular Formula:
Product Number:PCL-#-Me051-25mg Methyl p-chlorobenzoate Product Name:Methyl p-chlorobenzoate CAS No.:1126-46-1 Molecular Formula:
Product Number:PCL-#-Me812-50mg Venlafaxine hydrochloride impurity IM01-A Product Name:Venlafaxine hydrochloride impurity IM01-A CAS No.:55-81-2 Molecular Formula:
Product Number:PCL-#-Al007-10ml Chloropropylene Product Name:Chloropropylene CAS No.:107-05-1 Molecular Formula:
Product Number:PCL-#-Fl006-100mg Fmoc-Pbf-arginine Product Name:Fmoc-Pbf-arginine CAS No.:N/A Molecular Formula:
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