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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-#-Se002-5ml 3-methylbutyl chloroformate Product Name:3-methylbutyl chloroformate CAS No.:17462-58-7 Molecular Formula:
Product Number:PCL-#-Pe021-100mg 2-(2-Cyanophenyl)benzonitrile Product Name:2-(2-Cyanophenyl)benzonitrile CAS No.:4341-02-0 Molecular Formula:
Product Number:PCL-#-Ar115-50mg H-Arg(Pbf)-OH Product Name:H-Arg(Pbf)-OH CAS No.:200115-86-2 Molecular Formula:
Product Number:PCL-#-Ch905-50mg 4-(Methylsulfonyl)benzeneacetic acid, the control product Product Name:4-(Methylsulfonyl)benzeneacetic acid, the control product CAS No.:90536-66-6 Molecular Formula:
Product Number:PCL-#-Me054-100mg N-methyl-2-(3,4-dimethoxyphenyl)ethylamine Product Name:N-methyl-2-(3,4-dimethoxyphenyl)ethylamine CAS No.:3490-06-0 Molecular Formula:
Product Number:PCL-#-Fm014-500mg Fmoc-L-phenylalanine (Fmoc-Phe-OH) Product Name:Fmoc-L-phenylalanine (Fmoc-Phe-OH) CAS No.:35661-40-6 Molecular Formula:
Product Number:PCL-#-Chp0418-50mg Clonoxicam impurityⅠ Product Name:Clonoxicam impurityⅠ CAS No.:504-29-0 Molecular Formula:
Product Number:PCL-#-Ch040-1g 2-chloropropane Product Name:2-chloropropane CAS No.:75-29-6 Molecular Formula:
Product Number:PCL-#-Pe022-100mg 2-Methoxy-5-(pyridin-2-yl)pyridine (pirempanel SM01-3) Product Name:2-Methoxy-5-(pyridin-2-yl)pyridine (pirempanel SM01-3) CAS No.:381725-49-1 Molecular Formula:
Product Number:PCL-#-Co360-20mg Coumarin 6 Product Name:Coumarin 6 CAS No.:38215-36-0 Molecular Formula:
Product Number:PCL-#-Et001-100mg 4-ethylmorpholine Product Name:4-ethylmorpholine CAS No.:100-74-3 Molecular Formula:
Product Number:PCL-#-Nd101-5ml N,N-Diisopropylethylamine; Ethyl-N,N-diisopropylamine Product Name:N,N-Diisopropylethylamine; Ethyl-N,N-diisopropylamine CAS No.:7087-68-5 Molecular Formula:
Product Number:PCL-#-Gu001-125mg guanfacine hydrochloride Product Name:guanfacine hydrochloride CAS No.:29110-48-3 Molecular Formula:
Product Number:PCL-#-Di095-50mg Donepezil impurities; Product Name:Donepezil impurities; CAS No.:2107-70-2 Molecular Formula:
Product Number:PCL-#-Py004-500mg 5-(2-Fluorophenyl)-1-[(pyridin-3-yl)sulfonyl]-1H-pyrrole-3-carbaldehyde Product Name:5-(2-Fluorophenyl)-1-[(pyridin-3-yl)sulfonyl]-1H-pyrrole-3-carbaldehyde CAS No.:881677-11-8 Molecular Formula:
Product Number:PCL-#-Ac987-25mg 2-Amino-6-acetyl-4,5,6,7-tetrahydrobenzothiazole; 2-Amino-6-acetyl-4,5,6,7-tetrahydrobenzothiazole; 2-Amino-6-acetyl-4,5,6,7-tetrahydrobenzothiazol Product Name:2-Amino-6-acetyl-4,5,6,7-tetrahydrobenzothiazole; 2-Amino-6-acetyl-4,5,6,7-tetrahydrobenzothiazole; 2-Amino-6-acetyl-4,5,6,7-tetrahydrobenzothiazol CAS No.:106006-80-8 Molecular Formula:
Product Number:PCL-#-Me084-50mg Venlafaxine EP impurity C; 1-[2-Amino-1-(4-methoxyphenyl)ethyl]cyclohexanol Product Name:Venlafaxine EP impurity C; 1-[2-Amino-1-(4-methoxyphenyl)ethyl]cyclohexanol CAS No.:93413-77-5 Molecular Formula:
Product Number:PCL-#-Va003-50mg Vadixib isomers Product Name:Vadixib isomers CAS No.:181695-72-7 Molecular Formula:
Product Number:PCL-#-Ch180-20mg Chondroitin A sulfate Product Name:Chondroitin A sulfate CAS No.:39455-18-0 Molecular Formula:
Product Number:PCL-#-Me066-25mg N-methylimidazole Product Name:N-methylimidazole CAS No.:616-47-7 Molecular Formula:
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