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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-#-Di033-100mg Dipropyl fumarate Product Name:Dipropyl fumarate CAS No.:14595-35-8 Molecular Formula:
Product Number:PCL-#-Di160-5ml 1,2-dibromopropane Product Name:1,2-dibromopropane CAS No.:78-75-1 Molecular Formula:
Product Number:PCL-#-B312-50mg Vortioxetine hydrobromide impurity A Product Name:Vortioxetine hydrobromide impurity A CAS No.:615-36-1 Molecular Formula:
Product Number:PCL-#-Me005-1ml methyl methacrylate Product Name:methyl methacrylate CAS No.:80-62-6 Molecular Formula:
Product Number:PCL-#-Al107-50mg β-Alanine (H-β-Ala-OH) Product Name:β-Alanine (H-β-Ala-OH) CAS No.:107-95-9 Molecular Formula:
Product Number:PCL-#-Mi006-100mg Mirabelone impurity 6 Product Name:Mirabelone impurity 6 CAS No.:391901-45-4 Molecular Formula:
Product Number:PCL-#- CB716-1ml Dibutyl phthalate Product Name:Dibutyl phthalate CAS No.:84-74-2 Molecular Formula:
Product Number:PCL-#-Di 0054-50mg 2,4-Dimethylbenzenesulfonyl chloride (Wolcetin hydrobromide impurity 10) Product Name:2,4-Dimethylbenzenesulfonyl chloride (Wolcetin hydrobromide impurity 10) CAS No.:609-60-9 Molecular Formula:
Product Number:PCL-#-Di0022-20mg Guanfacine hydrochloride impurity C, Product Name:Guanfacine hydrochloride impurity C, CAS No.:54551-83-6 Molecular Formula:
Product Number:PCL-#-Fl013-100mg Fmoc-L-leucine Product Name:Fmoc-L-leucine CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Br035-100mg (1,4-bis-benzo[b]thiophen-4-yl-piperazine) Product Name:(1,4-bis-benzo[b]thiophen-4-yl-piperazine) CAS No.:913614-18-3 Molecular Formula:
Product Number:PCL-#-Zo043-25mg Zolpidem tartrate Product Name:Zolpidem tartrate CAS No.:99294-93-6 Molecular Formula:
Product Number:PCL-#-C025-25mg Cangrelorin Product Name:Cangrelorin CAS No.:842133-18-0 Molecular Formula:
Product Number:PCL-#-A043-50mg Zolmitamide; (s)-4-(4-aminobenzyl)-1,3-oxazolidin-2-one, (s)-4-(4-aminobenzyl)-1,3-oxazolidin-2-one, (s)-4-(4-aminobenzyl)-1,3-oxazolidin-2-one Product Name:Zolmitamide; (s)-4-(4-aminobenzyl)-1,3-oxazolidin-2-one, (s)-4-(4-aminobenzyl)-1,3-oxazolidin-2-one, (s)-4-(4-aminobenzyl)-1,3-oxazolidin-2-one CAS No.:152305-23-2 Molecular Formula:
Product Number:PCL-#-Di405-100mg 2,6-Diaminotoluene Product Name:2,6-Diaminotoluene CAS No.:823-40-5 Molecular Formula:
Product Number:PCL-#-Me065-25mg methylaminoacetaldehyde dimethyl acetal Product Name:methylaminoacetaldehyde dimethyl acetal CAS No.:122-07-6 Molecular Formula:
Product Number:PCL-#-Ph007-1g m-Phenyltriol EP impurity D Product Name:m-Phenyltriol EP impurity D CAS No.:491-45-2 Molecular Formula:
Product Number:PCL-#-Me060-50mg Calcium levofolinate impurity A Product Name:Calcium levofolinate impurity A CAS No.:4271-30-1 Molecular Formula:
Product Number:PCL-#-Am002-100mg 2-amino-4-methylthiazole Product Name:2-amino-4-methylthiazole CAS No.:1603-91-4 Molecular Formula:
Product Number:PCL-#-Ib003-100mg tert-Butyl 2-hydroxypiperidine-1-carboxylate Product Name:tert-Butyl 2-hydroxypiperidine-1-carboxylate CAS No.:86953-81-3 Molecular Formula:
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