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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-#-Bz0078-50mg Atorvastatin impurity 14 Product Name:Atorvastatin impurity 14 CAS No.:693793-82-7 Molecular Formula:
Product Number:PCL-#-Bz0264-50mg Ethyl glycodeoxycholate Product Name:Ethyl glycodeoxycholate CAS No.:70779-06-5 Molecular Formula:
Product Number:PCL-#-Pr001-25mg Pramipexole EP impurity C (6S,6'S)-N6,N6'-(2-methylpentane-1,3-diyl)bis(4,5,6,7-tetrahydrobenzothiazole)-2,6-diamine Product Name:Pramipexole EP impurity C (6S,6'S)-N6,N6'-(2-methylpentane-1,3-diyl)bis(4,5,6,7-tetrahydrobenzothiazole)-2,6-diamine CAS No.:1973461-14-1 Molecular Formula:
Product Number:PCL-#-D033-25mg Aripiprazole Impurity II Product Name:Aripiprazole Impurity II CAS No.:129722-25-4 Molecular Formula:
Product Number:PCL-#-Et008-50mg Ethambutol EP impurity C Product Name:Ethambutol EP impurity C CAS No.:10054-05-4 Molecular Formula:
Product Number:PCL-#-Az556-50mg Azithromycin EP impurity L; Azithromycin nitrogen oxides Product Name:Azithromycin EP impurity L; Azithromycin nitrogen oxides CAS No.:90503-06-3 Molecular Formula:
Product Number:PCL-#-Bz0058-50mg Acyclovir impurity H Product Name:Acyclovir impurity H CAS No.:133186-23-9 Molecular Formula:
Product Number:PCL-#-Bz0244-50mg Acyclovir EP impurity I Product Name:Acyclovir EP impurity I CAS No.:1797832-75-7 Molecular Formula:
Product Number:PCL-#-A612-100mg Aripiprazole impurityⅠ (Aripiprazole N-oxide) Product Name:Aripiprazole impurityⅠ (Aripiprazole N-oxide) CAS No.:573691-09-5 Molecular Formula:
Product Number:PCL-#-At105-100mg Atropine EP impurity G Product Name:Atropine EP impurity G CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0143-50mg benzoylacetonitrile Product Name:benzoylacetonitrile CAS No.:614-16-4 Molecular Formula:
Product Number:PCL-#-Pr187-50mg Pramipexole impurity 820BS Product Name:Pramipexole impurity 820BS CAS No.:1001648-71-0 Molecular Formula:
Product Number:PCL-#-Am2333-25mg (S)-1-Amino-3-chloro-2-propanol hydrochloride Product Name:(S)-1-Amino-3-chloro-2-propanol hydrochloride CAS No.:34839-13-9 Molecular Formula:
Product Number:PCL-#-Br014-100mg R-chloromethylhexanoic acid (brivaracetam impurity 14) Product Name:R-chloromethylhexanoic acid (brivaracetam impurity 14) CAS No.:2101641-90-9 Molecular Formula:
Product Number:PCL-#-At100-25mg 1-(4-Amino-2-methylbenzoyl)-7-chloro-1,2,3,4-tetrahydro-5H-1-benzazepin-5-one Product Name:1-(4-Amino-2-methylbenzoyl)-7-chloro-1,2,3,4-tetrahydro-5H-1-benzazepin-5-one CAS No.:137977-97-0 Molecular Formula:
Product Number:PCL-#-Bz0430-50mg Imipenem EP impurity B Product Name:Imipenem EP impurity B CAS No.:780001-33-4/1197869-90-1 Molecular Formula:
Product Number:PCL-#-Pd144-25mg 1,5-Pentanediol diacrylate Product Name:1,5-Pentanediol diacrylate CAS No.:36840-85-4 Molecular Formula:
Product Number:PCL-#-Ri120-100mg Rivaroxaban enantiomers, rivaroxaban impurity F Product Name:Rivaroxaban enantiomers, rivaroxaban impurity F CAS No.:865479-71-6 Molecular Formula:
Product Number:PCL-#-Oi456-100mg Omeprazole impurity 4 Product Name:Omeprazole impurity 4 CAS No.:1803449-15-1 Molecular Formula:
Product Number:PCL-#-Pr900-100mg Pramipexole impurity Product Name:Pramipexole impurity CAS No.:1867177-06-7 Molecular Formula:
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