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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-#-Ni023-100mg Nicorandil impurity H Product Name:Nicorandil impurity H CAS No.:107833-98-7 Molecular Formula:
Product Number:PCL-#-Bz0385-50mg Tazobactam bromide Product Name:Tazobactam bromide CAS No.:24138-28-1 Molecular Formula:
Product Number:PCL-#-Chp0018-50mg Dehydroinosine impurity Ⅰ hypoxanthine Product Name:Dehydroinosine impurity Ⅰ hypoxanthine CAS No.:68-94-0 Molecular Formula:
Product Number:PCL-#-Nd100-25mg 2,9-Diacetylguanine Product Name:2,9-Diacetylguanine CAS No.:3056-33-5 Molecular Formula:
Product Number:PCL-#-Bz0342-50mg Meropenem side chain dimer-S Product Name:Meropenem side chain dimer-S CAS No.:936226-36-7 Molecular Formula:
Product Number:PCL-#-Py103-100mg Tandospirone impurity II (3aR,4S,7R,7aS)-2-[4-(4-pyrimidin-2-ylpiperazin-1-yl)butyl]-3a,4,7,7a-tetrahydro-1H-4,7-methylheteropolyol-1,3-dione Product Name:Tandospirone impurity II (3aR,4S,7R,7aS)-2-[4-(4-pyrimidin-2-ylpiperazin-1-yl)butyl]-3a,4,7,7a-tetrahydro-1H-4,7-methylheteropolyol-1,3-dione CAS No.:138332-79-3 Molecular Formula:
Product Number:PCL -#-I022-20mg Isobutylboronic acid Product Name:Isobutylboronic acid CAS No.:84110-40-7 Molecular Formula:
Product Number:PCL-#-C356-25mg Calcium carbapenems Product Name:Calcium carbapenems CAS No.:5749-67-7 Molecular Formula:
Product Number:PCL-#-No092-25mg Norfloxacin EP impurity H Product Name:Norfloxacin EP impurity H CAS No.:105440-01-5 Molecular Formula:
Product Number:PCL-#-Br012-100mg Brivaracetam impurity 12 Product Name:Brivaracetam impurity 12 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0156-50mg 2-[3-[1-(2-Hydroxyethyl)-4(1H)-quinolinylidene]-1-propen-1-yl]-3-methylbenzothiazole tetrafluoroborate Product Name:2-[3-[1-(2-Hydroxyethyl)-4(1H)-quinolinylidene]-1-propen-1-yl]-3-methylbenzothiazole tetrafluoroborate CAS No.:1029939-19-2 Molecular Formula:
Product Number:PCL-#-Me026-100mg p-Toluenesulfonylurea Product Name:p-Toluenesulfonylurea CAS No.:1694-06-0 Molecular Formula:
Product Number:PCL-#-Ta103-50mg trans-4-Aminocyclohexanol hydrochloride Product Name:trans-4-Aminocyclohexanol hydrochloride CAS No.:50910-54-8 Molecular Formula:
Product Number:PCL-#-Am117-50mg 4-Aminopiperidine (procaine impurity K) Product Name:4-Aminopiperidine (procaine impurity K) CAS No.:13035-19-3 Molecular Formula:
Product Number:PCL-#-Mi002-100mg Mirabelone impurity 2 Product Name:Mirabelone impurity 2 CAS No.:2489747-26-2 Molecular Formula:
Product Number:PCL-#-Er004-50mg Erythromycin impurity B Product Name:Erythromycin impurity B CAS No.:527-75-3 Molecular Formula:
Product Number:PCL-#-Di047-30mg 4-[1-(2,4-dimethylphenyl)-ethyl]-1H-imidazole (dexmedetomidine impurity D) Product Name:4-[1-(2,4-dimethylphenyl)-ethyl]-1H-imidazole (dexmedetomidine impurity D) CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Pi118-100mg Pimovanserin degradation impurity 3 (N-[(4-fluorophenyl)methyl]-1-methyl-4-piperidinamine) Product Name:Pimovanserin degradation impurity 3 (N-[(4-fluorophenyl)methyl]-1-methyl-4-piperidinamine) CAS No.:359878-47-0 Molecular Formula:
Product Number:PCL-#-Ch029-25mg Chlorpheniramine maleate impurity B Product Name:Chlorpheniramine maleate impurity B CAS No.:1202-34-2 Molecular Formula:
Product Number:PCL-#-Gu101-25mg Guaiacol EP impurity C Product Name:Guaiacol EP impurity C CAS No.:1797132-23-0 Molecular Formula:
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