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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-#-Di128-100mg dipropylmalonic acid Product Name:dipropylmalonic acid CAS No.:1636-27-7 Molecular Formula:
Product Number:PCL-#-Bz0142-50mg 1,3,7-trimethyluric acid Product Name:1,3,7-trimethyluric acid CAS No.:5415-44-1 Molecular Formula:
Product Number:PCL-#-Me047-30mg 1,4-Bis-[1-(2,3-dimethylphenyl)-ethyl]-1H-imidazole (impurity L) Product Name:1,4-Bis-[1-(2,3-dimethylphenyl)-ethyl]-1H-imidazole (impurity L) CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Az540-30mg Azithromycin impurity II (impurity B) [Azithromycin B] (2R,3R,4S,5R,8R,10R,11R,12S,13S,14R)-13-[[2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribose-pyranohexyl]oxy]-2-ethyl-4,10-dihydroxy-3,5,6,8,10,12,14-(2,6-dideoxy-3-C-methyl-3-(dimethylamino-β-D-xyloxyhexyl)oxy]-1-oxa-6-azaspirochelate (2,6-dideoxy-3-(dimethylamino-β-D-xyloxyhexyl)oxy]-1-oxa-6-azaspirochelate (2R,6D) heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylulose-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one Product Name:Azithromycin impurity II (impurity B) [Azithromycin B] (2R,3R,4S,5R,8R,10R,11R,12S,13S,14R)-13-[[2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribose-pyranohexyl]oxy]-2-ethyl-4,10-dihydroxy-3,5,6,8,10,12,14-(2,6-dideoxy-3-C-methyl-3-(dimethylamino-β-D-xyloxyhexyl)oxy]-1-oxa-6-azaspirochelate (2,6-dideoxy-3-(dimethylamino-β-D-xyloxyhexyl)oxy]-1-oxa-6-azaspirochelate (2R,6D) heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylulose-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one CAS No.:307974-61-4 Molecular Formula:
Product Number:PCL-#-Bz0026-50mg m-Hydroxylamine impurity 3 Product Name:m-Hydroxylamine impurity 3 CAS No.:1824725-09-8 Molecular Formula:
Product Number:PCL-#-Am707-25mg Bromhexine hydrochloride impurity B; 2-amino-3,5-dibromobenzaldehyde Product Name:Bromhexine hydrochloride impurity B; 2-amino-3,5-dibromobenzaldehyde CAS No.:50910-55-9 Molecular Formula:
Product Number:PCL-#-Up514-100mg Omeprazole impurity 6 Product Name:Omeprazole impurity 6 CAS No.:73590-85-9 Molecular Formula:
Product Number:PCL-#-A043-100mg Zolmitriptan impurity E Product Name:Zolmitriptan impurity E CAS No.:152305-23-2 Molecular Formula:
Product Number:PCL-#-Qu014-50mg Quetiapine EP impurity O Product Name:Quetiapine EP impurity O CAS No.:844639-06-1 Molecular Formula:
Product Number:PCL-#-Bz0441-50mg Bromhexine hydrochloride related impurity 4 Product Name:Bromhexine hydrochloride related impurity 4 CAS No.:21237-84-3 Molecular Formula:
Product Number:PCL-#-Pe033-20mg Pemetrexed EP impurity D Product Name:Pemetrexed EP impurity D CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0272-50mg Erlotinib impurity 367 Product Name:Erlotinib impurity 367 CAS No.:1494468-76-6 Molecular Formula:
Product Number:PCL-#-Ol006-100mg Olopatadine-ɑ-hydroxy impurity USP-A Product Name:Olopatadine-ɑ-hydroxy impurity USP-A CAS No.:1331822-32-2 Molecular Formula:
Product Number:PCL-#-Or101-50mg triphenylphosphine oxide Product Name:triphenylphosphine oxide CAS No.:791-28-6 Molecular Formula:
Product Number:PCL-#-Fl016-50mg Fmoc-β-Ala-His(Trt)-OH Product Name:Fmoc-β-Ala-His(Trt)-OH CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Pr027-50mg Pranoprofen impurity M Product Name:Pranoprofen impurity M CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Ii105-25mg Ibuprofen EP impurity G Product Name:Ibuprofen EP impurity G CAS No.:1391054-15-1 Molecular Formula:
Product Number:PCL-#-Mn100-50mg 2-methyl-4-nitrobenzoic acid Product Name:2-methyl-4-nitrobenzoic acid CAS No.:1975-51-5 Molecular Formula:
Product Number:PCL-#-En003-100mg Enalapril impurity F Product Name:Enalapril impurity F CAS No.:76391-34-9 Molecular Formula:
Product Number:PCL-#-Bz0447-50mg Ivabradine impurity 1 Product Name:Ivabradine impurity 1 CAS No.:85175-52-6 Molecular Formula:
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