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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-#-Bz0169-50mg BETA-hydroxyethyl theophylline Product Name:BETA-hydroxyethyl theophylline CAS No.:519-37-9 Molecular Formula:
Product Number:PCL-#-Bz0040-50mg Pantoprazole impurity 12 Product Name:Pantoprazole impurity 12 CAS No.:122307-41-9 Molecular Formula:
Product Number:PCL-#-Az003-50mg Dimethyl sulfite Product Name:Dimethyl sulfite CAS No.:616-42-2 Molecular Formula:
Product Number:PCL-#-Es001-50mg Escitalopram impurity A Product Name:Escitalopram impurity A CAS No.:64372-56-1 Molecular Formula:
Product Number:PCL-#-Li183-100mg Ritarestat impurity E (Ritarestat impurity IM01 chiral isomer) Product Name:Ritarestat impurity E (Ritarestat impurity IM01 chiral isomer) CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0112-50mg Ethiprone impurity B Product Name:Ethiprone impurity B CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Ep002-100mg 2,2-Bis[4-(acryloyloxy-propoxy)phenyl]propane Product Name:2,2-Bis[4-(acryloyloxy-propoxy)phenyl]propane CAS No.:55818-57-0 Molecular Formula:
Product Number:PCL-#-Pa677-25mg Palonosetron impurity E Product Name:Palonosetron impurity E CAS No.:135729-55-4 Molecular Formula:
Product Number:PCL-#-Mo100-50mg Moxifloxacin impurity H Product Name:Moxifloxacin impurity H CAS No.:1403836-23-6 Molecular Formula:
Product Number:PCL-#-Ni020-100mg Nicorandil impurity B Product Name:Nicorandil impurity B CAS No.:6265-73-2 Molecular Formula:
Product Number:PCL-#-Pr100-25mg Pramipexole EP impurity E Product Name:Pramipexole EP impurity E CAS No.:106006-80-8 Molecular Formula:
Product Number:PCL-#-Fm874-20mg Fmoc-L-citrulline Product Name:Fmoc-L-citrulline CAS No.:133174-15-9 Molecular Formula:
Product Number:PCL-#-Di150-50mg 3,5-Dihydroxyacetophenone Product Name:3,5-Dihydroxyacetophenone CAS No.:51863-60-6 Molecular Formula:
Product Number:PCL-#-Sp100-25mg (S)-(-)- α-methylbenzylamine Product Name:(S)-(-)- α-methylbenzylamine CAS No.:2627-86-3 Molecular Formula:
Product Number:PCL-#-Am100-50mg Sodium p-aminosalicylate impurity Ⅰ m-aminophenol Product Name:Sodium p-aminosalicylate impurity Ⅰ m-aminophenol CAS No.:591-27-5 Molecular Formula:
Product Number:PCL-#-Bz0372-50mg Pramipexole Impurity BI-II546CL (Racemic hydrochloride) Product Name:Pramipexole Impurity BI-II546CL (Racemic hydrochloride) CAS No.:2245708-68-1（HCl) Molecular Formula:
Product Number:PCL-#-Bz0056-50mg Acyclovir impurity F Product Name:Acyclovir impurity F CAS No.:110104-37-5 Molecular Formula:
Product Number:PCL-#-Or001-50mg Ornidazole impurity 7 Product Name:Ornidazole impurity 7 CAS No.:1348117-98-5 Molecular Formula:
Product Number:PCL-#-Bz0225-50mg Paclitaxel EP impurity L Product Name:Paclitaxel EP impurity L CAS No.:92950-39-5 Molecular Formula:
Product Number:PCL-#-Ca044-50mg Sodium carboxysulfonate impurity 6 Product Name:Sodium carboxysulfonate impurity 6 CAS No.:130570-60-4 Molecular Formula:
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