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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-#-Li540-25mg Salbutamol impurity Q Product Name:Salbutamol impurity Q CAS No.:54030-32-9 Molecular Formula:
Product Number:PCL-#-Li156-25mg Salbutamol impurity D Product Name:Salbutamol impurity D CAS No.:156339-88-7 Molecular Formula:
Product Number:PCL-#-Li463-25mg Salbutamol impurity F Product Name:Salbutamol impurity F CAS No.:147663-30-7 Molecular Formula:
Product Number:PCL-#-ME660-100mg (z)-2-methylcinnamaldehyde Product Name:(z)-2-methylcinnamaldehyde CAS No.:66051-14-7 Molecular Formula:
Product Number:PCL-#-Tr111-100mg Lipoic acid impurity bis(amide) Product Name:Lipoic acid impurity bis(amide) CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Li131-25mg Lipoic acid impurity 18 Product Name:Lipoic acid impurity 18 CAS No.:# Molecular Formula:
Product Number:PCL-#-Li130-25mg Lipoic acid impurity 40 Product Name:Lipoic acid impurity 40 CAS No.:2114407-76-8 Molecular Formula:
Product Number:PCL-#-Li129-25mg Lipoic acid impurity 39 Product Name:Lipoic acid impurity 39 CAS No.:2114407-78-0 Molecular Formula:
Product Number:PCL-#-Li128-25mg Lipoic acid impurity 34 Product Name:Lipoic acid impurity 34 CAS No.:2114407-82-6 Molecular Formula:
Product Number:PCL-#-Li127-25mg Lipoic acid impurity 33 Product Name:Lipoic acid impurity 33 CAS No.:2114407-83-7 Molecular Formula:
Product Number:PCL-#-Li124-25mg Lipoic acid impurity 19 Product Name:Lipoic acid impurity 19 CAS No.:940-69-2 Molecular Formula:
Product Number:PCL-#-Fi030-100mg Fenelidone impurity 25 Product Name:Fenelidone impurity 25 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fi029-100mg Fenelidone impurity 24 Product Name:Fenelidone impurity 24 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fi028-100mg Fenelidone impurity 23 Product Name:Fenelidone impurity 23 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fi027-100mg Fenelidone impurity 22 Product Name:Fenelidone impurity 22 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fi054-100mg Fenelidone impurity 21 Product Name:Fenelidone impurity 21 CAS No.:2084136-51-4 Molecular Formula:
Product Number:PCL-#-Fi025-100mg Fenelidone impurity 20 Product Name:Fenelidone impurity 20 CAS No.:2640280-84-6 Molecular Formula:
Product Number:PCL-#-Fi024-100mg Fenelidone impurity 19 Product Name:Fenelidone impurity 19 CAS No.:2640280-85-7 Molecular Formula:
Product Number:PCL-#-Fi050-25mg Fenelidone impurity 1 (isomer) Product Name:Fenelidone impurity 1 (isomer) CAS No.:1050477-30-9 Molecular Formula:
Product Number:PCL-#-Fi059-25mg Fenelidone impurity 12 (intermediate FNLT-3) Product Name:Fenelidone impurity 12 (intermediate FNLT-3) CAS No.:1050477-58-1 Molecular Formula:
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