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-#-At001-50mg Atropine EP impurity A Product Name:Atropine EP impurity A CAS No.:500-55-0 Molecular Formula:
Product Number:PCL-#-Di097-50mg Donepezil impurity; 5,6-Dimethoxy-2-(4-piperidinylmethyl)-1-indanone hydrochloride Product Name:Donepezil impurity; 5,6-Dimethoxy-2-(4-piperidinylmethyl)-1-indanone hydrochloride CAS No.:120013-39-0 Molecular Formula:
Product Number:PCL-#-Li158-50mg Lidocaine impurity G Product Name:Lidocaine impurity G CAS No.:42459-30-3 Molecular Formula:
Product Number:PCL-#-Me125-100mg Epiprazole impurity 52 Product Name:Epiprazole impurity 52 CAS No.:15116-41-3 Molecular Formula:
Product Number:PCL-#-Pe031-20mg Pemetrexed EP impurity B/C Product Name:Pemetrexed EP impurity B/C CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0115-50mg Eperisone impurity E Product Name:Eperisone impurity E CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Ol004-100mg Olopatadine E-isomer impurity Product Name:Olopatadine E-isomer impurity CAS No.:949141-22-4 Molecular Formula:
Product Number:PCL-#-Fl012-100mg Fmoc-L-isoleucine (Fmoc-lle-OH) Product Name:Fmoc-L-isoleucine (Fmoc-lle-OH) CAS No.:71989-23-6 Molecular Formula:
Product Number:PCL-#-Mp134-100mg 4-Methylbenzophenone Product Name:4-Methylbenzophenone CAS No.:134-84-9 Molecular Formula:
Product Number:PCL-#-At002-100mg Atropine EP impurity B Product Name:Atropine EP impurity B CAS No.:16839-98-8 Molecular Formula:
Product Number:PCL-#-Bz0276-50mg Erlotinib impurity 253 Product Name:Erlotinib impurity 253 CAS No.:183320-15-2 Molecular Formula:
Product Number:PCL-#-Bz0344-50mg Montelukastenitrile impurity Product Name:Montelukastenitrile impurity CAS No.:866923-62-8 Molecular Formula:
Product Number:PCL-#-MH02-10mg Matemacrophenol ester impurity H, Product Name:Matemacrophenol ester impurity H, CAS No.:79081-87-1 Molecular Formula:
Product Number:PCL-#-Li102-100mg Linezolid impurity LN-3-F Product Name:Linezolid impurity LN-3-F CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0175-50mg (S)-3-Amino-2-methyl-2-hydroxybutane hydrochloride Product Name:(S)-3-Amino-2-methyl-2-hydroxybutane hydrochloride CAS No.:74608-26-7 Molecular Formula:
Product Number:PCL-#-Ro002-100mg Rotigotine impurity C Product Name:Rotigotine impurity C CAS No.:153409-14-4 Molecular Formula:
Product Number:PCL-#-Bz0436-50mg Amitranan impurity C Product Name:Amitranan impurity C CAS No.:102579-59-9 Molecular Formula:
Product Number:PCL-#-Bz0014-50mg Lipoic acid monooxide impurity 3 Product Name:Lipoic acid monooxide impurity 3 CAS No.:2114407-78-0 Molecular Formula:
Product Number:PCL-#-Te036-100mg 6,7-Dichloro-1,2,3,4-tetrahydro-isoquinoline hydrochloride Product Name:6,7-Dichloro-1,2,3,4-tetrahydro-isoquinoline hydrochloride CAS No.:73075-49-7 Molecular Formula:
Product Number:PCL-#-Bz0371-50mg Pramipexole Impurity BI-II546CL (Racemic Free) Product Name:Pramipexole Impurity BI-II546CL (Racemic Free) CAS No.:1286047-33-3（游离） Molecular Formula:
  1. <
  2. 63
  3. 64
  4. 65
  5. 66
  6. 67
  7. >
1
2
3
4
5
6
HomeEmailContact