Open Nav
Home Products Pharmaceutical Testing Reference Mterials Impurity reference standards

Products

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-#-Os108-100mg Oseltamivir impurity 4; (1R,5S,6R)-ethyl 5-(pentan-3-yloxy)-7-oxa[4.1.0]hept-3-ene-3-carboxylate Product Name:Oseltamivir impurity 4; (1R,5S,6R)-ethyl 5-(pentan-3-yloxy)-7-oxa[4.1.0]hept-3-ene-3-carboxylate CAS No.:347378-74-9 Molecular Formula:
Product Number:PCL-#-Li007-50mg Linezolid impurity M Product Name:Linezolid impurity M CAS No.:189038-36-6 Molecular Formula:
Product Number:PCL-#-Bz0099-50mg Chlorpheniramine EP impurity D Product Name:Chlorpheniramine EP impurity D CAS No.:65676-21-3 Molecular Formula:
Product Number:PCL-#-Bz0215-50mg Thiamine EP impurity G Product Name:Thiamine EP impurity G CAS No.:1037-29-2 Molecular Formula:
Product Number:PCL-#-Bz0071-50mg Atorvastatin impurity 6 Product Name:Atorvastatin impurity 6 CAS No.:693794-20-6 Molecular Formula:
Product Number:PCL-#-Bz0285-50mg Erlotinib Impurity EL-6-102 Product Name:Erlotinib Impurity EL-6-102 CAS No.:236750-62-2 Molecular Formula:
Product Number:PCL-#-Es046-50mg Zopiclone impurity B Product Name:Zopiclone impurity B CAS No.:43200-81-3 Molecular Formula:
Product Number:PCL-#-Am007-50mg 3-Amino-2-cyclohexen-1-one Product Name:3-Amino-2-cyclohexen-1-one CAS No.:5220-49-5 Molecular Formula:
Product Number:PCL-#-Dm105-50mg Dextromethorphan hydrobromide impurity VI Product Name:Dextromethorphan hydrobromide impurity VI CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0029-50mg m-Hydroxylamine isomer 1 Product Name:m-Hydroxylamine isomer 1 CAS No.:21480-44-4 Molecular Formula:
Product Number:PCL-#-Bz0300-50mg Entecavir impurity E Product Name:Entecavir impurity E CAS No.:2203740-23-0 Molecular Formula:
Product Number:PCL-#-Ai229-50mg Acetaminophen EP Impurity I Product Name:Acetaminophen EP Impurity I CAS No.:118-93-4 Molecular Formula:
Product Number:PCL-#-Az537-50mg Azithromycin impurity F Product Name:Azithromycin impurity F CAS No.:612069-28-0 Molecular Formula:
Product Number:PCL#-Et100-50mg Ethylenediaminetriacetic acid; N-(Carboxymethyl)-N-2-(carboxymethyl)aminoethylglycine; Triacetic acid impurity 1 Product Name:Ethylenediaminetriacetic acid; N-(Carboxymethyl)-N-2-(carboxymethyl)aminoethylglycine; Triacetic acid impurity 1 CAS No.:688-57-3 Molecular Formula:
Product Number:PCL-#-De040-50mg Dextromethorphan EP impurity A Product Name:Dextromethorphan EP impurity A CAS No.:1531-23-3 Molecular Formula:
Product Number:PCL-#-Zg035-25mg benzyloxycarbonyl-glycyl-L-tyrosine benzyl ester Product Name:benzyloxycarbonyl-glycyl-L-tyrosine benzyl ester CAS No.:57294-46-9 Molecular Formula:
Product Number:PCL-#-Ii102-50mg Ibuprofen EP impurity L Product Name:Ibuprofen EP impurity L CAS No.:53949-53-4 Molecular Formula:
Product Number:PCL-#-Bz0114-50mg Ethiprone impurity D Product Name:Ethiprone impurity D CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Tr010-150mg 1,1,2-Trimethyl-1H-benzo[e]indole Product Name:1,1,2-Trimethyl-1H-benzo[e]indole CAS No.:41532-84-7 Molecular Formula:
Product Number:PCL-#-Dm122-50mg 1-phenyl-3-methyl-5-pyrazolone Product Name:1-phenyl-3-methyl-5-pyrazolone CAS No.:19735-89-8 Molecular Formula:
  1. <
  2. 85
  3. 86
  4. 87
  5. 88
  6. 89
  7. >
1
2
3
4
5
6
HomeEmailContact