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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-#-Ch0231-50mg 2-Chloromethyl-3,4-dimethoxypyridine hydrochloride Product Name:2-Chloromethyl-3,4-dimethoxypyridine hydrochloride CAS No.:72830-09-2 Molecular Formula:
Product Number:PCL-#-Fl026-25mg 4-fluoronitrobenzene Product Name:4-fluoronitrobenzene CAS No.:350-46-9 Molecular Formula:
Product Number:PCL-#-Ri109-50mg Racemic Cadotril intermediate impurity R, Product Name:Racemic Cadotril intermediate impurity R, CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Fo003-50mg Calcium levofolinate impurity C Product Name:Calcium levofolinate impurity C CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0307-50mg Flurbiprofen impurity 15 Product Name:Flurbiprofen impurity 15 CAS No.:87657-78-1 Molecular Formula:
Product Number:PCL-#-Az949-100mg 3-chlorophenylacetic acid Product Name:3-chlorophenylacetic acid CAS No.:1878-65-5 Molecular Formula:
Product Number:PCL-#-Ai225-25mg Acetaminophen EP impurity E (p-hydroxyacetophenone) Product Name:Acetaminophen EP impurity E (p-hydroxyacetophenone) CAS No.:99-93-4 Molecular Formula:
Product Number:PCL-#-Th091-50mg Lipoic acid impurity 14 Product Name:Lipoic acid impurity 14 CAS No.:25636-58-2 Molecular Formula:
Product Number:PCL-#-Bz0126-50mg Hydroxyethyl p-toluenesulfonate Product Name:Hydroxyethyl p-toluenesulfonate CAS No.:42772-85-0 Molecular Formula:
Product Number:PCL-#-Bz0042-50mg Pantoprazole impurity 16 Product Name:Pantoprazole impurity 16 CAS No.:141854-21-9 Molecular Formula:
Product Number:PCL-#-Fm102-500mg Fmoc-S-trityl-D-cysteine Product Name:Fmoc-S-trityl-D-cysteine CAS No.:167015-11-4 Molecular Formula:
Product Number:PCL-#-B1464-20mg benzyl benzoate Product Name:benzyl benzoate CAS No.:120-51-4 Molecular Formula:
Product Number:PCL-#-Li084-25mg Linezolid impurity A Product Name:Linezolid impurity A CAS No.:78692-88-3 Molecular Formula:
Product Number:PCL-#-Ar053-50mg Aripiprazole impurity D; Aripiprazole USP impurity D Product Name:Aripiprazole impurity D; Aripiprazole USP impurity D CAS No.:882880-12-8 Molecular Formula:
Product Number:PCL-#-Ab539-500mg 2-aminobenzenethiol Product Name:2-aminobenzenethiol CAS No.:137-07-5 Molecular Formula:
Product Number:PCL-#-To599-100mg p-Toluenesulfonyl chloride Product Name:p-Toluenesulfonyl chloride CAS No.:98-59-9 Molecular Formula:
Product Number:PCL-#-Is028-50mg 4-Isopropylphenol; p-Isopropylphenol Product Name:4-Isopropylphenol; p-Isopropylphenol CAS No.:99-89-8 Molecular Formula:
Product Number:PCL-#-Qu013-50mg quetiapine ep impurity n. Product Name:quetiapine ep impurity n. CAS No.:1800291-86-4 Molecular Formula:
Product Number:PCL-#-Am0968-25mg Amoxicillin impurity G Product Name:Amoxicillin impurity G CAS No.:188112-75-6 Molecular Formula:
Product Number:PCL-#-Cl038-25mg 6-chloro-3-methyluracil Product Name:6-chloro-3-methyluracil CAS No.:4318-56-3 Molecular Formula:
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