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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-#-Er005-50mg Erythromycin impurity C Product Name:Erythromycin impurity C CAS No.:1675-02-1 Molecular Formula:
Product Number:PCL-#-Ta698-100mg Atropine EP impurity C; scopolamine EP impurity C Product Name:Atropine EP impurity C; scopolamine EP impurity C CAS No.:552-63-6 Molecular Formula:
Product Number:PCL-#-Bz0383-50mg Hydrochlorothiazide EP impurity C/hydrochlorothiazide dimer Product Name:Hydrochlorothiazide EP impurity C/hydrochlorothiazide dimer CAS No.:402824-96-8 Molecular Formula:
Product Number:PCL-#-Bz0036-50mg Pantoprazole impurity 8 Product Name:Pantoprazole impurity 8 CAS No.:953787-51-4 Molecular Formula:
Product Number:PCL-#-Bz0084-50mg Allopurinol impurity H Product Name:Allopurinol impurity H CAS No.:41621-10-7 Molecular Formula:
Product Number:PCL-#-Bz0222-50mg 4-Phenyl-3-morpholinone Product Name:4-Phenyl-3-morpholinone CAS No.:29518-11-4 Molecular Formula:
Product Number:PCL-#-Chp0769-50mg Ciprofloxacin impurity CP impurity D Product Name:Ciprofloxacin impurity CP impurity D CAS No.:526204-10-4 Molecular Formula:
Product Number:PCL-#-Ra010-25mg Racemic Cardotril with impurity B Product Name:Racemic Cardotril with impurity B CAS No.:76721-89-6 Molecular Formula:
Product Number:PCL-#-Os106-50mg Ethyl (3R,4R,5S)-5-acetamido-4-amino-3-(pent-3-yloxy)cyclohex-1-ene-1-carboxylate; oseltamivir EP impurity G Product Name:Ethyl (3R,4R,5S)-5-acetamido-4-amino-3-(pent-3-yloxy)cyclohex-1-ene-1-carboxylate; oseltamivir EP impurity G CAS No.:956267-10-0 Molecular Formula:
Product Number:PCL-#-Su0314-100mg 5-Aminosulfonyl-2-methoxybenzoic acid; Sulpiride EP Impurity D Product Name:5-Aminosulfonyl-2-methoxybenzoic acid; Sulpiride EP Impurity D CAS No.:22117-85-7 Molecular Formula:
Product Number:PCL-#-Ol017-25mg Olopatadine hydrochloride impurity 8 Product Name:Olopatadine hydrochloride impurity 8 CAS No.:113835-92-0 Molecular Formula:
Product Number:PCL-#-Bz0086-50mg Midapril impurity F Product Name:Midapril impurity F CAS No.:107716-98-3 Molecular Formula:
Product Number:PCL-#-Br050-20mg Brimonidine dimer impurity (EP impurity K) Product Name:Brimonidine dimer impurity (EP impurity K) CAS No.:N/A Molecular Formula:
Product Number:PCL-#-A0125-20mg Acylated amino acid hydrolases Product Name:Acylated amino acid hydrolases CAS No.:9012-37-7 Molecular Formula:
Product Number:PCL-#-Bz0043-50mg Omeprazole impurity 5 Product Name:Omeprazole impurity 5 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Es004-100mg Escitalopram USP impurity D Product Name:Escitalopram USP impurity D CAS No.:144025-14-9 Molecular Formula:
Product Number:PCL-#-Te030-100mg 5-Chloro-1,2,3,4-tetrahydroisoquinoline hydrochloride Product Name:5-Chloro-1,2,3,4-tetrahydroisoquinoline hydrochloride CAS No.:799274-05-8 Molecular Formula:
Product Number:PCL-#-Oc063-50mg octyl chloroformate Product Name:octyl chloroformate CAS No.:7452-59-7 Molecular Formula:
Product Number:PCL-#-Pa674-25mg Palonosetron impurity D Product Name:Palonosetron impurity D CAS No.:135755-51-0 Molecular Formula:
Product Number:PCL-#-Nt039-50mg Enalapril impurity G Product Name:Enalapril impurity G CAS No.:N/A Molecular Formula:
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