Open Nav
Home Products Pharmaceutical Testing Reference Mterials Impurity reference standards

Products

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-#-Di021-100mg 5'-Deoxy-5-fluorocytidine; Capecitabine impurity A Product Name:5'-Deoxy-5-fluorocytidine; Capecitabine impurity A CAS No.:66335-38-4 Molecular Formula:
Product Number:PCL-#-Va008-50mg Parecoxib sodium impurity 4 Product Name:Parecoxib sodium impurity 4 CAS No.:1373038-60-8 Molecular Formula:
Product Number:PCL-#-Ep600-20mg Prednisolone EP impurity F Product Name:Prednisolone EP impurity F CAS No.:600-90-8 Molecular Formula:
Product Number:PCL-#-Mm418-25mg Esomeprazole sodium impurity V Product Name:Esomeprazole sodium impurity V CAS No.:37052-78-1 Molecular Formula:
Product Number:PCL-#-Me803-20mg Methotrexate impurity L Product Name:Methotrexate impurity L CAS No.:52980-68-4 Molecular Formula:
Product Number:PCL-#-Di570-25mg Droxidopa impurity 2 Product Name:Droxidopa impurity 2 CAS No.:5707-55-1 Molecular Formula:
Product Number:PCL-#-Ni350-25mg Isoprenaline impurity 15 Product Name:Isoprenaline impurity 15 CAS No.:3506-32-9 Molecular Formula:
Product Number:PCL-#-Hi984-25mg 1-Isopropylindoline-3,5,6-triol Product Name:1-Isopropylindoline-3,5,6-triol CAS No.:98496-30-1 Molecular Formula:
Product Number:PCL-#-Ly556-25mg 4-(2-Chloroacetyl)-1,2-phenylene bis(2-chloroacetate) Product Name:4-(2-Chloroacetyl)-1,2-phenylene bis(2-chloroacetate) CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bi105-50mg Hydroxybilastine Product Name:Hydroxybilastine CAS No.:1638785-23-5 Molecular Formula:
Product Number:PCL-#-Me094-10mg Betahistine hydrochloride impurity C Product Name:Betahistine hydrochloride impurity C CAS No.:5452-87-9 Molecular Formula:
Product Number:PCL-#-Vi099-10mg Betahistine hydrochloride impurity A Product Name:Betahistine hydrochloride impurity A CAS No.:100-69-6 Molecular Formula:
Product Number:PCL-#-Ac674-100mg Dienone Product Name:Dienone CAS No.:674-82-8 Molecular Formula:
Product Number:PCL-#-Bi035-50mg Bisoprolol impurity A Product Name:Bisoprolol impurity A CAS No.:62572-93-4 Molecular Formula:
Product Number:PCL-#-Hx589-100mg 5,6-dimethyl-1-nitroso-1H-benzimidazole Product Name:5,6-dimethyl-1-nitroso-1H-benzimidazole CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Ax256-25mg Ambroxol hydrochloride impurity S Product Name:Ambroxol hydrochloride impurity S CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bi097 (1R)-1-((4R,4aR,8aS)-2,6-Bis(3,4-dimethylphenyl)tetrahydro-[1,3]dioxolo[5,4-d][1,3]dioxolan-4-yl)ethane-1,2-diol Product Name:(1R)-1-((4R,4aR,8aS)-2,6-Bis(3,4-dimethylphenyl)tetrahydro-[1,3]dioxolo[5,4-d][1,3]dioxolan-4-yl)ethane-1,2-diol CAS No.:135861-56-2 Molecular Formula:
Product Number:PCL-#-Fi030-50mg Fenelidone nitrosamine impurity Product Name:Fenelidone nitrosamine impurity CAS No.:# Molecular Formula:
Product Number:PCL-#-Fi029-50mg Fenelidone nitrogen oxidizing impurities Product Name:Fenelidone nitrogen oxidizing impurities CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Ni073-100mg Nilotinib nitrosamine impurities Product Name:Nilotinib nitrosamine impurities CAS No.:N/A Molecular Formula:
  1. <
  2. 17
  3. 18
  4. 19
  5. 20
  6. 21
  7. >
1
2
3
4
5
6
HomeEmailContact