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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-#-Cy071-50mg Acetylcysteine impurity A (L-cystine) Product Name:Acetylcysteine impurity A (L-cystine) CAS No.:56-89-3 Molecular Formula:
Product Number:PCL-#-Ra021-50mg Racemic Cardotril impurity P (3-(acetylthio)-2-benzylpropionyl)glycine benzyl ester Product Name:Racemic Cardotril impurity P (3-(acetylthio)-2-benzylpropionyl)glycine benzyl ester CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Chp0317-50mg Nalmefene hydrochloride impurity Product Name:Nalmefene hydrochloride impurity CAS No.:16676-29-2 Molecular Formula:
Product Number:PCL-#-Az540-10mg Azithromycin impurity B Product Name:Azithromycin impurity B CAS No.:307974-61-4 Molecular Formula:
Product Number:PCL-#-Vo008-1g vincristine hydrobromide Product Name:vincristine hydrobromide CAS No.:960203-27-4 Molecular Formula:
Product Number:PCL-#-Et219-1g ethyl trifluoroacetate Product Name:ethyl trifluoroacetate CAS No.:383-63-1 Molecular Formula:
Product Number:PCL-#-Ai114-50mg Aripiprazole Deethylenated Impurity (Deethylenated Aripiprazole) Product Name:Aripiprazole Deethylenated Impurity (Deethylenated Aripiprazole) CAS No.:1216394-63-6 Molecular Formula:
Product Number:PCL-#-Di006-50mg 2,3-dimethylbromobenzene Product Name:2,3-dimethylbromobenzene CAS No.:576-23-8 Molecular Formula:
Product Number:PCL-#-Gr100-100mg Granisetron EP Impurity D; 1-Methyl-1H-indazole-3-carboxylic acid; Granisetron Hydrochloride Impurity D Product Name:Granisetron EP Impurity D; 1-Methyl-1H-indazole-3-carboxylic acid; Granisetron Hydrochloride Impurity D CAS No.:50890-83-0 Molecular Formula:
Product Number:PCL-#-Am003-100mg trans-4-acetamidocyclohexanol Product Name:trans-4-acetamidocyclohexanol CAS No.:27489-60-7 Molecular Formula:
Product Number:PCL-#-De036-10mg Dexamethasone EP impurity C Product Name:Dexamethasone EP impurity C CAS No.:426-17-5 Molecular Formula:
Product Number:PCL-#-Bz0221-50mg N-methyl-3-phenyl-2-propen-1-amine Product Name:N-methyl-3-phenyl-2-propen-1-amine CAS No.:83554-67-0 Molecular Formula:
Product Number:PCL-#-Bz0166-50mg Chlorpheniramine N-oxide Product Name:Chlorpheniramine N-oxide CAS No.:142494-45-9 Molecular Formula:
Product Number:PCL-#-D697-100mg Diethyl fumarate Product Name:Diethyl fumarate CAS No.:623-91-6 Molecular Formula:
Product Number:PCL-#-Bz0352-50mg Nicorandil dimer nitrate Product Name:Nicorandil dimer nitrate CAS No.:2250142-73-1 Molecular Formula:
Product Number:PCL-#-To001-100mg Tolvaptib impurity B Product Name:Tolvaptib impurity B CAS No.:1092578-48-7 Molecular Formula:
Product Number:PCL-#-Da166-100mg Omeprazole impurity 2 Product Name:Omeprazole impurity 2 CAS No.:1227380-90-6 Molecular Formula:
Product Number:PCL-#-Bz0035-50mg Pantoprazole impurity 7 Product Name:Pantoprazole impurity 7 CAS No.:953787-47-8 Molecular Formula:
Product Number:PCL-#-Ro020-100mg Ropivacaine EP impurity D Product Name:Ropivacaine EP impurity D CAS No.:98626-59-6 Molecular Formula:
Product Number:PCL-#-Ap004-50mg Apremilast impurity A Product Name:Apremilast impurity A CAS No.:635705-72-5 Molecular Formula:
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