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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-#-S0131-10mg Atorvastatin calcium impurity S Product Name:Atorvastatin calcium impurity S CAS No.:1315629-79-8 Molecular Formula:
Product Number:PCL-#-Py015-100mg [Des-Pyr1] treprostinil Product Name:[Des-Pyr1] treprostinil CAS No.:N/A Molecular Formula:
Product Number:PCL-#-At011-25mg Atorvastatin epoxypyrrolizine 6-hydroxy analog Product Name:Atorvastatin epoxypyrrolizine 6-hydroxy analog CAS No.:1316291-19-6 Molecular Formula:
Product Number:PCL-#-At010-25mg atorvastatin pyrrolidone analogs Product Name:atorvastatin pyrrolidone analogs CAS No.:148217 -40-7 Molecular Formula:
Product Number:PCL-#-Or010-100mg [Orn8] treprostinil Product Name:[Orn8] treprostinil CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Gl013-100mg [Glu1] treprostinil Product Name:[Glu1] treprostinil CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Ty002-100mg [Des-Tyr5] treprostinil Product Name:[Des-Tyr5] treprostinil CAS No.:N/A Molecular Formula:
Product Number:PCL-#-At013-25mg Atorvastatin epoxy tetrahydrofuran analogs Product Name:Atorvastatin epoxy tetrahydrofuran analogs CAS No.:873950-19-7 Molecular Formula:
Product Number:PCL-#-Ep004-50mg Epinastine EP impurity B Product Name:Epinastine EP impurity B CAS No.:1217052-16-8 Molecular Formula:
Product Number:PCL-#-Mo012-50mg Moxifloxacin impurity 29 Product Name:Moxifloxacin impurity 29 CAS No.:1620445-12-6 Molecular Formula:
Product Number:PCL-#-Ap006-50mg Apixaban Impurity 116 Product Name:Apixaban Impurity 116 CAS No.:1998079-16-5 Molecular Formula:
Product Number:PCL-#-De039-100mg Rocuronium bromide impurity VI Product Name:Rocuronium bromide impurity VI CAS No.:1190105-67-9 Molecular Formula:
Product Number:PCL-#-De064-20mg Ursodeoxycholic acid EP impurity E Product Name:Ursodeoxycholic acid EP impurity E CAS No.:83-44-3 Molecular Formula:
Product Number:PCL-#-U374-20mg Ursodeoxycholic acid; Product Name:Ursodeoxycholic acid; CAS No.:128-13-2 Molecular Formula:
Product Number:PCL-#-C1364-100mg Ursodeoxycholic acid EP impurity B Product Name:Ursodeoxycholic acid EP impurity B CAS No.:81-25-4 Molecular Formula:
Product Number:PCL-#-F1272-50mg Fumaric acid Product Name:Fumaric acid CAS No.:110-17-8 Molecular Formula:
Product Number:PCL-#-Ci327-0.5ml trans-Cinnamaldehyde Product Name:trans-Cinnamaldehyde CAS No.:14371-10-9 Molecular Formula:
Product Number:PCL-#-Az533-10mg Azithromycin impurity M Product Name:Azithromycin impurity M CAS No.:765927-71-7 Molecular Formula:
Product Number:PCL-#-Ur104-25mg Ursodeoxycholic acid EP impurity I; 5β-cholan-3α,7β,24 triol Product Name:Ursodeoxycholic acid EP impurity I; 5β-cholan-3α,7β,24 triol CAS No.:130593-75-8 Molecular Formula:
Product Number:PCL-#-Bz0110-50mg Chlorpheniramine impurity S Product Name:Chlorpheniramine impurity S CAS No.:N/A Molecular Formula:
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