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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-#-Cu005-50mg Isopropyl benzenesulfonate Product Name:Isopropyl benzenesulfonate CAS No.:6214-18-2 Molecular Formula:
Product Number:PCL-#-Bz0310-50mg tofacitinib perhydrogenated citrate Product Name:tofacitinib perhydrogenated citrate CAS No.:1809002-40-1 Molecular Formula:
Product Number:PCL-#-Bh100-50mg tert-butyl-4-hydroxyanisole Product Name:tert-butyl-4-hydroxyanisole CAS No.:25013-16-5 Molecular Formula:
Product Number:PCL-#-Bz0191-50mg 2-methyl-5-ethoxymethyl-6-chloropyrimidine Product Name:2-methyl-5-ethoxymethyl-6-chloropyrimidine CAS No.:749835-80-1 Molecular Formula:
Product Number:PCL-#-Di0023-50mg 3,4-Dichlorophenylacetic acid Product Name:3,4-Dichlorophenylacetic acid CAS No.:5807-30-7 Molecular Formula:
Product Number:PCL-#-Ib002-100mg Ibrutinib Impurity IM01-2 Product Name:Ibrutinib Impurity IM01-2 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Pr001-100mg Pramipexole EP impurity C (6S,6'S)-N6,N6'-(2-methylpentane-1,3-diyl)bis(4,5,6,7-tetrahydrobenzothiazole)-2,6-diamine Product Name:Pramipexole EP impurity C (6S,6'S)-N6,N6'-(2-methylpentane-1,3-diyl)bis(4,5,6,7-tetrahydrobenzothiazole)-2,6-diamine CAS No.:1973461-14-1 Molecular Formula:
Product Number:PCL-#-Bz0351-50mg Nicorandil Dimer Chloride Product Name:Nicorandil Dimer Chloride CAS No.:2250142-73-2 Molecular Formula:
Product Number:PCL-#-Ke901-25mg (2S,3R,4S,5R,6R)-2-(((1S,2R,3R)-1-((6R)-4-(6-(2-((2,6-dichlorophenyl)oxy)ethoxy)hexyl)-2-hydroxy-6-(4-hydroxy-3-(hydroxymethyl)phenyl)morpholin-2-yl)-1,3,4-trihydroxybutan-2-yl)oxy)-6-(hydroxymethyl)tetrahydro -2H-pyran-3,4,5-triol; Vilanterol triacetate impurity 9; Vilanterol impurity 27 Product Name:(2S,3R,4S,5R,6R)-2-(((1S,2R,3R)-1-((6R)-4-(6-(2-((2,6-dichlorophenyl)oxy)ethoxy)hexyl)-2-hydroxy-6-(4-hydroxy-3-(hydroxymethyl)phenyl)morpholin-2-yl)-1,3,4-trihydroxybutan-2-yl)oxy)-6-(hydroxymethyl)tetrahydro -2H-pyran-3,4,5-triol; Vilanterol triacetate impurity 9; Vilanterol impurity 27 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Pr392-25mg 2,2-Di-n-propylacetamide; 2-Propylpentanamide Product Name:2,2-Di-n-propylacetamide; 2-Propylpentanamide CAS No.:2430-27-5 Molecular Formula:
Product Number:PCL-#-Me107-100mg 1-Methyl-2-pyrrolidone; N-Methylpyrrolidone Product Name:1-Methyl-2-pyrrolidone; N-Methylpyrrolidone CAS No.:872-4 Molecular Formula:
Product Number:PCL-#-E664-25mg Dexzopiclone process impurity P, Product Name:Dexzopiclone process impurity P, CAS No.:1122549-43-2 Molecular Formula:
Product Number:PCL-#-Bz0077-50mg Atorvastatin impurity 13 Product Name:Atorvastatin impurity 13 CAS No.:581772-29-4 Molecular Formula:
Product Number:PCL-#-Bz0061-50mg Acyclovir impurity M Product Name:Acyclovir impurity M CAS No.:91702-60-2 Molecular Formula:
Product Number:PCL-#-Bz0376-50mg Prucalopride intermediate 3 impurity 3 Product Name:Prucalopride intermediate 3 impurity 3 CAS No.:137211-64-4 Molecular Formula:
Product Number:PCL-#-Ch121-50mg N,N-dimethyl-3-chloropropylamine Product Name:N,N-dimethyl-3-chloropropylamine CAS No.:109-54-6 Molecular Formula:
Product Number:PCL-#-Di0054-50mg 2,4-Dimethylbenzenesulfonyl chloride Product Name:2,4-Dimethylbenzenesulfonyl chloride CAS No.:609-60-9 Molecular Formula:
Product Number:PCL-#-Zo009-50mg Zoledronic acid impurity C(1,3-bis-(2-hydroxy-2,2-bisphosphonoethyl)-3H-imidazole-1-trimethyl) Product Name:Zoledronic acid impurity C(1,3-bis-(2-hydroxy-2,2-bisphosphonoethyl)-3H-imidazole-1-trimethyl) CAS No.:1632236-60-2（2043362-88-3氯盐） Molecular Formula:
Product Number:PCL-#-Bu208-100mg Butyl nipagin; Butyl 4- hydroxybenzoate Product Name:Butyl nipagin; Butyl 4- hydroxybenzoate CAS No.:94-26-8 Molecular Formula:
Product Number:PCL-#-Ve802-100mg Venlafaxine N- oxide (venlafaxine impurity L) Product Name:Venlafaxine N- oxide (venlafaxine impurity L) CAS No.:1094598-37-4 Molecular Formula:
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