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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-#-Na100-100mg N-(3-Bromo-4-oxocyclohexyl)acetamide. Product Name:N-(3-Bromo-4-oxocyclohexyl)acetamide. CAS No.:687639-03-8 Molecular Formula:
Product Number:PCL-#-Ib007-100mg Ibrutinib impurity 6 Product Name:Ibrutinib impurity 6 CAS No.:936563- 92-7 Molecular Formula:
Product Number:PCL-#-Ib006-100mg Ibrutinib impurity 1 Product Name:Ibrutinib impurity 1 CAS No.:936563- 97-2 Molecular Formula:
Product Number:PCL-#-Pr112-25mg Pramipexole impurity M Product Name:Pramipexole impurity M CAS No.:# Molecular Formula:
Product Number:PCL-#-Pa017-20mg Pazufloxacin impurity 14 Product Name:Pazufloxacin impurity 14 CAS No.:127046-18-8 Molecular Formula:
Product Number:PCL-#-Py245-25mg Tofacitib impurity O Product Name:Tofacitib impurity O CAS No.:2459302-77-1 Molecular Formula:
Product Number:PCL-#-Be047-100mg N-(2-bromophenyl)nitrosamide Product Name:N-(2-bromophenyl)nitrosamide CAS No.:876497-67-5 Molecular Formula:
Product Number:PCL-#-Di153-25mg Bromhexine hydrochloride impurity A Product Name:Bromhexine hydrochloride impurity A CAS No.:50739-76-9 Molecular Formula:
Product Number:PCL-MO298-10mg Levofloxacin EP impurity F Product Name:Levofloxacin EP impurity F CAS No.:N/A Molecular Formula:
Product Number:PCL-#- Yk001- 50mg Irinotecan EP impurity G Product Name:Irinotecan EP impurity G CAS No.:947687-01-6 Molecular Formula:
Product Number:PCL-#-Ph110-100mg levophosphoramidite Product Name:levophosphoramidite CAS No.:25383-07-7 Molecular Formula:
Product Number:PCL-NI113-10mg N-nitrosopseudopalmatine (NNN) Product Name:N-nitrosopseudopalmatine (NNN) CAS No.:1133-64-8 Molecular Formula:
Product Number:PCL-RA805-25mg N-nitrosonicotinic acid Product Name:N-nitrosonicotinic acid CAS No.:80508-23-2 Molecular Formula:
Product Number:PCL-CA120-100mg o-Phenylenediol Product Name:o-Phenylenediol CAS No.:120-80-9 Molecular Formula:
Product Number:PCL-PH602-100Mg 9-Phenylanthracene standard substance Product Name:9-Phenylanthracene standard substance CAS No.:602-55-1 Molecular Formula:
Product Number:PCL-#-NB152-100mg butanal 2,4-dinitrophenylhydrazine Product Name:butanal 2,4-dinitrophenylhydrazine CAS No.:1527-98-6 Molecular Formula:
Product Number:PCL-CR152-100mg butenal 2,4 dinitrophenylhydrazine Product Name:butenal 2,4 dinitrophenylhydrazine CAS No.:1527-96-4 Molecular Formula:
Product Number:PCL-#PR725-100mg propionaldehyde 2,4 dinitrophenylhydrazine Product Name:propionaldehyde 2,4 dinitrophenylhydrazine CAS No.:725-00-8 Molecular Formula:
Product Number:PCL-#-FO108-100mg formaldehyde 2,4 dinitrophenylhydrazine Product Name:formaldehyde 2,4 dinitrophenylhydrazine CAS No.:1081-15-8 Molecular Formula:
Product Number:PCL-#-AC156-50mg acetone 2,4 dinitrophenylhydrazine Product Name:acetone 2,4 dinitrophenylhydrazine CAS No.:1567-89-1 Molecular Formula:
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