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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-#-Di013-50mg Ethyl 6,8 dichlorooctanoate Product Name:Ethyl 6,8 dichlorooctanoate CAS No.:1070-64-0 Molecular Formula:
Product Number:PCL-#-Ol140-100mg Acetaminophen impurity M (4,4'-iminodiol) Product Name:Acetaminophen impurity M (4,4'-iminodiol) CAS No.:1752-24-5 Molecular Formula:
Product Number:PCL-#-Chp0027-25mg Propofol impurity II 2,6-diisopropyl-1,4-benzoquinone Product Name:Propofol impurity II 2,6-diisopropyl-1,4-benzoquinone CAS No.:1988-11-0 Molecular Formula:
Product Number:PCL-#-Am895-100mg 5-aminosalicylic acid Product Name:5-aminosalicylic acid CAS No.:89-57-6 Molecular Formula:
Product Number:PCL-#-Be035-100mg Rifepristone impurity SM01 control (benzofuran-6-carboxylic acid (SM01)) Product Name:Rifepristone impurity SM01 control (benzofuran-6-carboxylic acid (SM01)) CAS No.:77095-51-3 Molecular Formula:
Product Number:PCL-#-Ol005-25mg Olopatadine E-isomer isopropyl ester Product Name:Olopatadine E-isomer isopropyl ester CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Pe115-100mg Paramivir impurity K Product Name:Paramivir impurity K CAS No.:288-88-0 Molecular Formula:
Product Number:PCL-#-Pe113-100mg Paramivir Impurity ZEN1904-5 Product Name:Paramivir Impurity ZEN1904-5 CAS No.:19503-26-5 Molecular Formula:
Product Number:PCL-#-Teb153-25mg 2-tert-butyl-1,2,3,4-tetrahydroisoquinoline-4,6,8-triol (terbutaline sulfate impurity B) Product Name:2-tert-butyl-1,2,3,4-tetrahydroisoquinoline-4,6,8-triol (terbutaline sulfate impurity B) CAS No.:153657-83-1 Molecular Formula:
Product Number:PCL-#-Chp0209-50mg Ciprofloxacin impurity D Product Name:Ciprofloxacin impurity D CAS No.:133210-96-5 Molecular Formula:
Product Number:PCL-#-Di751-10mg Disodium 4,4'-(diazamido)dibenzenesulfonate Product Name:Disodium 4,4'-(diazamido)dibenzenesulfonate CAS No.:56120-28-6 Molecular Formula:
Product Number:PCL-#-Di750-20mg 3-Carboxy-1-(4-sulfophenyl)-5-pyrazolone disodium salt Product Name:3-Carboxy-1-(4-sulfophenyl)-5-pyrazolone disodium salt CAS No.:3473-75-4 Molecular Formula:
Product Number:PCL-#-Pc102-20mg 1-(4'-Sulfophenyl)-3-carboxylic acid ethyl esteryl-5-pyrazolone sodium salt Product Name:1-(4'-Sulfophenyl)-3-carboxylic acid ethyl esteryl-5-pyrazolone sodium salt CAS No.:20514-27-6 Molecular Formula:
Product Number:PCL-#-Lo015-25mg Roclofen-related compound 9 (6-(4-carboxy(hydroxy)methyl)phenyl)-5-hydroxyhexanoic acid) Product Name:Roclofen-related compound 9 (6-(4-carboxy(hydroxy)methyl)phenyl)-5-hydroxyhexanoic acid) CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Lo011-25mg Roclofen-related compound 4 (6-[4-(1-carboxyethyl)phenyl]-6-oxohexanoic acid) Product Name:Roclofen-related compound 4 (6-[4-(1-carboxyethyl)phenyl]-6-oxohexanoic acid) CAS No.:2514697-36-8 Molecular Formula:
Product Number:PCL-#-Lo010-25mg Roclofen-related compound 3 (2-(4-acetylbenzyl)cyclopentanone) Product Name:Roclofen-related compound 3 (2-(4-acetylbenzyl)cyclopentanone) CAS No.:96824-28-1 Molecular Formula:
Product Number:PCL-#-Ox347-250mg Ethyl 3-oxopropionate sodium salt Product Name:Ethyl 3-oxopropionate sodium salt CAS No.:34780-29-5 Molecular Formula:
Product Number:PCL-#-Ni010-50mg Nicorandil impurity G Product Name:Nicorandil impurity G CAS No.:4665-58-1 Molecular Formula:
Product Number:PCL-#-On028-50mg Ondansetron hydrochloride impurity G Product Name:Ondansetron hydrochloride impurity G CAS No.:99614-03-6 Molecular Formula:
Product Number:PCL-#-Br121-100mg Brexpiprazole BPZ-36 impurity Product Name:Brexpiprazole BPZ-36 impurity CAS No.:N/A Molecular Formula:
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