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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-#-To021-100mg Tofacitinib impurity N Product Name:Tofacitinib impurity N CAS No.:2459302-85-1 Molecular Formula:
Product Number:PCL-#-Sa002-20mg Albuterol sulfate impurity N, Product Name:Albuterol sulfate impurity N, CAS No.:149222-15-1 Molecular Formula:
Product Number:PCL-#-Pr021-50mg Pranoprofen impurity E Product Name:Pranoprofen impurity E CAS No.:145986-74-9 Molecular Formula:
Product Number:PCL-#-Bz0050-50mg Bile acid impurity 1 Product Name:Bile acid impurity 1 CAS No.:15073-99-1 Molecular Formula:
Product Number:PCL-#-At006-30mg Atorvastatin Calcium Impurity III, a control product Product Name:Atorvastatin Calcium Impurity III, a control product CAS No.:693793-53-2 Molecular Formula:
Product Number:PCL-#-Li006-50mg Linezolid impurity L Product Name:Linezolid impurity L CAS No.:1219708-30-1 Molecular Formula:
Product Number:PCL-#-Bz0203-50mg 9-acridinecarbonyl chloride Product Name:9-acridinecarbonyl chloride CAS No.:66074-67-7 Molecular Formula:
Product Number:PCL-#-Bz0080-50mg cysteine impurities Product Name:cysteine impurities CAS No.:14226-97-2 Molecular Formula:
Product Number:PCL-#-Me019-100mg 2-Hydroxy-3-methoxybenzaldehyde Product Name:2-Hydroxy-3-methoxybenzaldehyde CAS No.:148-53-8 Molecular Formula:
Product Number:PCL-#-Ai102-50mg Aripiprazole EP impurity A Product Name:Aripiprazole EP impurity A CAS No.:22246-18-0 Molecular Formula:
Product Number:PCL-#-Bz0165-50mg Olanzapine thiolactam Product Name:Olanzapine thiolactam CAS No.:1017241-36-9 Molecular Formula:
Product Number:PCL-#-Bz0233-50mg Atorvastatin-amlodipine dimer Product Name:Atorvastatin-amlodipine dimer CAS No.:425408-16-8 Molecular Formula:
Product Number:PCL-#-Bz0364-50mg Sodium picosulfate M2Z2 Product Name:Sodium picosulfate M2Z2 CAS No.:747-36-4 Molecular Formula:
Product Number:PCL-#-Qu005-50mg Quetiapine EP impurity E, Product Name:Quetiapine EP impurity E, CAS No.:1371638-05-9 Molecular Formula:
Product Number:PCL-#-Pr029-25mg Pranoprofen impurity 7 Product Name:Pranoprofen impurity 7 CAS No.:86618-09-9 Molecular Formula:
Product Number:PCL-#-Ai220-100mg acetaminophen impurity B; paracetamol Product Name:acetaminophen impurity B; paracetamol CAS No.:1693-37-4 Molecular Formula:
Product Number:PCL-#-Chp0971-20mg Levofloxacin EP impurity H Product Name:Levofloxacin EP impurity H CAS No.:177472-30-9 Molecular Formula:
Product Number:PCL-#-Bz0093-50mg Tolperisone impurities D Product Name:Tolperisone impurities D CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Am0981-25mg Ambroxol impurity H Product Name:Ambroxol impurity H CAS No.:2088879-81-4 Molecular Formula:
Product Number:PCL-#-Di040-25mg 3,5-Diisopropyl o-hydroxybenzoic acid Product Name:3,5-Diisopropyl o-hydroxybenzoic acid CAS No.:2215-21-6 Molecular Formula:
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