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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-#-Fi021-100mg Fenelidone impurity 16 Product Name:Fenelidone impurity 16 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fi020-100mg Fenelidone impurity 15 Product Name:Fenelidone impurity 15 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fi019-100mg Fenelidone impurity 14 Product Name:Fenelidone impurity 14 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fi018-100mg Fenelidone impurity 13 Product Name:Fenelidone impurity 13 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fi056-25mg Fenelidone impurity 9 (intermediate FNLT-5) Product Name:Fenelidone impurity 9 (intermediate FNLT-5) CAS No.:1050477-44-5 Molecular Formula:
Product Number:PCL-#-Fi016-100mg Fenelidone IM03-4 Product Name:Fenelidone IM03-4 CAS No.:2764833-09-0 Molecular Formula:
Product Number:PCL-#-Fi015-100mg Fenelidone impurity 10 Product Name:Fenelidone impurity 10 CAS No.:2924224-42-8 Molecular Formula:
Product Number:PCL-#-Fi014-100mg Fenelidone impurity 9 Product Name:Fenelidone impurity 9 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fi013-100mg Fenelidone impurity 8 Product Name:Fenelidone impurity 8 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fi012-100mg Fenelidone impurity 7 Product Name:Fenelidone impurity 7 CAS No.:959934-80-6 Molecular Formula:
Product Number:PCL-#-Fi011-100mg Fenelidone impurity 6 Product Name:Fenelidone impurity 6 CAS No.:890038-13-8 Molecular Formula:
Product Number:PCL-#-Fi010-100mg Fenelidone impurity 5 Product Name:Fenelidone impurity 5 CAS No.:2385172-54-1 Molecular Formula:
Product Number:PCL-#-Fi009-100mg Fenelidone impurity 4 Product Name:Fenelidone impurity 4 CAS No.:487060-63-9 Molecular Formula:
Product Number:PCL-#-Fi008-100mg Fenaridone SM03 impurity 4 Product Name:Fenaridone SM03 impurity 4 CAS No.:2733513-87-4 Molecular Formula:
Product Number:PCL-#-Fi007-100mg Fenelidone impurity 2/3-methylpiperidin-4-amine Product Name:Fenelidone impurity 2/3-methylpiperidin-4-amine CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fi006-100mg Fenaridone SM03 impurity 2 Product Name:Fenaridone SM03 impurity 2 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Mi106-10mg Mecuronium chloride Product Name:Mecuronium chloride CAS No.:106861-44-3 Molecular Formula:
Product Number:PCL-#-Pr201-25mg Pramipexole hydrochloride impurity CD10503 Product Name:Pramipexole hydrochloride impurity CD10503 CAS No.:# Molecular Formula:
Product Number:PCL-#-Is210-25mg Seroxipar impurity 1 Product Name:Seroxipar impurity 1 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Mo025-100mg Mosapride citrate. Product Name:Mosapride citrate. CAS No.:636582-62-2 Molecular Formula:
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