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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-#-G511-20mg 4-Guanidinobutyric acid Product Name:4-Guanidinobutyric acid CAS No.:463-00-3 Molecular Formula:
Product Number:PCL-#-Ph102-50mg Phenylephrine EP impurity E Product Name:Phenylephrine EP impurity E CAS No.:71786-67-9 Molecular Formula:
Product Number:PCL-#-F112-1g 2-(Aminomethyl)-4-(4-fluorobenzyl)morpholine Product Name:2-(Aminomethyl)-4-(4-fluorobenzyl)morpholine CAS No.:112914-13-3 Molecular Formula:
Product Number:PCL-#-Im003-50mg Lidocaine hydrochloride impurity P Product Name:Lidocaine hydrochloride impurity P CAS No.:95-64-7 Molecular Formula:
Product Number:PCL-#-Am102-50mg 4-amino-2-methylbenzoic acid Product Name:4-amino-2-methylbenzoic acid CAS No.:2486-75-1 Molecular Formula:
Product Number:PCL-#-B312-100mg Vortioxetine hydrobromide impurity A ;2-bromoaniline Product Name:Vortioxetine hydrobromide impurity A ;2-bromoaniline CAS No.:615-36-1 Molecular Formula:
Product Number:PCL-#-Cp109-50mg Clindamycin phosphate CP impurity ⅰ; Methyl 7- chloro -6,7,8- tri-deoxy-6-[[(2S, 4R)-4- ethyl -1- methylpyrrolidine -2- yl] carbonyl] amino ]-2-O- phosphine -1- thio -L- threonine -α-D- galactose-octa. Clindamycin phosphate EP impurity b; Clindamycin b phosphate Product Name:Clindamycin phosphate CP impurity ⅰ; Methyl 7- chloro -6,7,8- tri-deoxy-6-[[(2S, 4R)-4- ethyl -1- methylpyrrolidine -2- yl] carbonyl] amino ]-2-O- phosphine -1- thio -L- threonine -α-D- galactose-octa. Clindamycin phosphate EP impurity b; Clindamycin b phosphate CAS No.:54887-31-9 Molecular Formula:
Product Number:PCL-#-Bz0076-50mg Atorvastatin impurity 12 Product Name:Atorvastatin impurity 12 CAS No.:134395-00-9 Molecular Formula:
Product Number:PCL-#-Om001-50mg Omeprazole impurity IX(5-hydroxy-2-[[3,5-dimethyl-2-pyridin-4-one-yl)methyl]sulfinyl]-1H-benzimidazole Product Name:Omeprazole impurity IX(5-hydroxy-2-[[3,5-dimethyl-2-pyridin-4-one-yl)methyl]sulfinyl]-1H-benzimidazole CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Br049-20mg 2,3-Dioxobrommonidine (EP impurity J) Product Name:2,3-Dioxobrommonidine (EP impurity J) CAS No.:182627-95-8 Molecular Formula:
Product Number:PCL-#-Pr002-50mg Propofol impurity C Product Name:Propofol impurity C CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Es003-50mg Escitalopram impurity C Product Name:Escitalopram impurity C CAS No.:372941-54-3 Molecular Formula:
Product Number:PCL-#-Bm173-50mg Captopril impurity D Product Name:Captopril impurity D CAS No.:56970-78-6 Molecular Formula:
Product Number:PCL-#-Bz0192-50mg 5-ethoxymethyl-2-methylpyrimidin-4-ylamine Product Name:5-ethoxymethyl-2-methylpyrimidin-4-ylamine CAS No.:73-66-5 Molecular Formula:
Product Number:PCL-#-Mo107-25mg Moxifloxacin Impurity 17; Ethyl 1-cyclopropyl-6,7,8-trifluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylate Product Name:Moxifloxacin Impurity 17; Ethyl 1-cyclopropyl-6,7,8-trifluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylate CAS No.:94242-51-0 Molecular Formula:
Product Number:PCL-#-Be061-25mg 2-aminobenzothiazole Product Name:2-aminobenzothiazole CAS No.:136-95-8 Molecular Formula:
Product Number:PCL-#-Bz0182-50mg tert-Butyl 2,4-dipiperidone-1-carboxylate Product Name:tert-Butyl 2,4-dipiperidone-1-carboxylate CAS No.:845267-78-9 Molecular Formula:
Product Number:PCL-#-Bz0021-50mg meso-hydroxylamine catalyst Product Name:meso-hydroxylamine catalyst CAS No.:862095-91-8 Molecular Formula:
Product Number:PCL-#-T352-20mg 2,3,5-Trimethyl-2,5-cyclohexadiene-1,4-dione Product Name:2,3,5-Trimethyl-2,5-cyclohexadiene-1,4-dione CAS No.:935-92-2 Molecular Formula:
Product Number:PCL-#-Do048-50mg Donepezil impurity C; Donepezil N-oxide Product Name:Donepezil impurity C; Donepezil N-oxide CAS No.:120013-84-5 Molecular Formula:
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