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-#-Bz0358-50mg Pitavastatin 5-oxo-calcium salt Product Name:Pitavastatin 5-oxo-calcium salt CAS No.:2180095-22-9 Molecular Formula:
Product Number:PCL-#-Bz0158-50mg Salbutamol impurity H Product Name:Salbutamol impurity H CAS No.:132183-64-3 Molecular Formula:
Product Number:PCL-#-Op167-50mg Octanoylbenzene Product Name:Octanoylbenzene CAS No.:1674-37-9 Molecular Formula:
Product Number:PCL-#-V033-50mg Vonorazan fumarate impurity 12 Product Name:Vonorazan fumarate impurity 12 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0024-50mg meso-hydroxylamine positional isomers Product Name:meso-hydroxylamine positional isomers CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Vo113-50mg Vonorazan fumarate impurity 11 Product Name:Vonorazan fumarate impurity 11 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Di0029-50mg Methyl 2,4-dichlorophenylacetate Product Name:Methyl 2,4-dichlorophenylacetate CAS No.:55954-23-9 Molecular Formula:
Product Number:PCL-#-Mo108-25mg Moxifloxacin Impurity 10; Ethyl 1-cyclopropyl-8-ethoxy-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate Product Name:Moxifloxacin Impurity 10; Ethyl 1-cyclopropyl-8-ethoxy-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylate CAS No.:172602-83-4 Molecular Formula:
Product Number:PCL-#-Me040-25mg Moxifloxacin impurity C Product Name:Moxifloxacin impurity C CAS No.:1029364-75-7 Molecular Formula:
Product Number:PCL-#-Do042-50mg 5,6-Dimethyl-1-indone Product Name:5,6-Dimethyl-1-indone CAS No.:16440-97-4 Molecular Formula:
Product Number:PCL-#-Am397-100mg 1-amino-4-cyclopentylpiperazine Product Name:1-amino-4-cyclopentylpiperazine CAS No.:61379-64-4 Molecular Formula:
Product Number:PCL-#-Os138-100mg Omeprazole impurity 10 Product Name:Omeprazole impurity 10 CAS No.:158812-85-2 Molecular Formula:
Product Number:PCL-#-Fi101-50mg Fasudil impurity 2 Product Name:Fasudil impurity 2 CAS No.:1352414-81-3 Molecular Formula:
Product Number:PCL-#-He0653-50mg 1,1,1,3,3,3 hexamethyldisilazane Product Name:1,1,1,3,3,3 hexamethyldisilazane CAS No.:999-97-3 Molecular Formula:
Product Number:PCL-#-Cp105-50mg Clindamycin phosphate impurity L(7 epiclindamycin phosphate) Product Name:Clindamycin phosphate impurity L(7 epiclindamycin phosphate) CAS No.:620181-05-7 Molecular Formula:
Product Number:PCL-#-Na2341-50mg 4- amino -1- naphthalene sulfonic acid Product Name:4- amino -1- naphthalene sulfonic acid CAS No.:84-86-6 Molecular Formula:
Product Number:PCL-#-Br045-20mg 4,5- Didehydrobrimonidine (EP impurity F) Product Name:4,5- Didehydrobrimonidine (EP impurity F) CAS No.:151110-15-5 Molecular Formula:
Product Number:PCL-#-Bz0243-50mg Acyclovir EP impurity j Product Name:Acyclovir EP impurity j CAS No.:166762-90-9 Molecular Formula:
Product Number:PCL-#-Bz0171-50mg Diltiazem acetyl and lactam double hydrolysis products Product Name:Diltiazem acetyl and lactam double hydrolysis products CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0426-50mg Nifedipine impurity g Product Name:Nifedipine impurity g CAS No.:74378-10-2 Molecular Formula:
  1. <
  2. 99
  3. 100
  4. 101
  5. 102
  6. 103
  7. >
1
2
3
4
5
6
HomeEmailContact