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Pharmaceutical Testing Reference Mterials

Pharmaceutical Reference Materials (PRMs) refer to substances with defined characteristic values used for calibrating instruments, evaluating measurement methods, or assigning values to tested pharmaceuticals in physical/chemical tests and biological assays specified by pharmacopoeial standards. These include reference standards, comparators, herbal reference materials, and reference preparations.

Hengyuan Fine Chemical specializes in providing cost-effective reference material solutions for pharmaceutical quality control, encompassing:

  • Drug testing reference standards
  • Pharmaceutical impurity reference standards
  • NIFDC-certified reference materials
  • Chemical analysis reference standards
  • Traditional Chinese Medicine (TCM) analytical standards
  • TCM reference standards
  • Herbal blank matrices for pesticide residue testing
  • Bio-peptide reference standards
All products under our PCL brand comply with both national standards and international guidelines. Our accreditations include:

  • CNAS certification (China National Accreditation Service for Conformity Assessment)
  • ISO 17034:2016 certification for reference material producers
  • ISO 9001:2015 quality management system certification We implement a comprehensive quality management system supported by Certificates of Analysis (COA), ensuring high purity (>98%), batch-to-batch consistency, and full traceability. Our solutions are widely applied in pharmaceutical R&D, QC testing, and analytical verification to enhance testing accuracy and operational efficiency.

Through our vertically integrated business model (R&D-production-sales), we eliminate intermediaries to deliver:

 ✓ Bulk supply capacities for routine QC needs 

✓ Custom synthesis services for specialized compounds 

✓ 30-50% cost reduction versus market averages 

✓ Streamlined procurement workflows 

This dual approach establishes economically optimized yet reliable quality control frameworks for clients across the pharmaceutical value chain.



Product Number Image Product Name CAS No. Molecular Formula
Product Number:PCL-#-Do056-25mg Donepezil impurity B Product Name:Donepezil impurity B CAS No.:120013-45-8 Molecular Formula:
Product Number:PCL-#-Ni005-100mg N-nitrosodiphenylamine Product Name:N-nitrosodiphenylamine CAS No.:86-30-6 Molecular Formula:
Product Number:PCL-#-Li012-50mg Lidocaine EP impurity A (2,6-dimethylaniline) Product Name:Lidocaine EP impurity A (2,6-dimethylaniline) CAS No.:87-62-7 Molecular Formula:
Product Number:PCL-#-To003-100mg Tofacitinib impurity J Product Name:Tofacitinib impurity J CAS No.:2328165-36-0 Molecular Formula:
Product Number:PCL-#-Me017-100mg N-methylaniline Product Name:N-methylaniline CAS No.:100-61-8 Molecular Formula:
Product Number:PCL-#-Ri026-50mg Rivaroxaban impurity G (5-chlorothiophene-2-carboxamide) Product Name:Rivaroxaban impurity G (5-chlorothiophene-2-carboxamide) CAS No.:97799-98-9 Molecular Formula:
Product Number:PCL-#-Su0312-50mg Methyl 2-methoxy-5-sulfamoylbenzoate; Product Name:Methyl 2-methoxy-5-sulfamoylbenzoate; CAS No.:33045-52-2 Molecular Formula:
Product Number:PCL-#-Gr101-100mg Granisetron EP impurity C; N-(3-lactam)-9-azabicyclo[3.3.1]non-3-yl-1-methyl-1H-indazole-3-carboxamide Product Name:Granisetron EP impurity C; N-(3-lactam)-9-azabicyclo[3.3.1]non-3-yl-1-methyl-1H-indazole-3-carboxamide CAS No.:160177-67-3 Molecular Formula:
Product Number:PCL-#-Ii110-25mg Ibuprofen EP impurity M Product Name:Ibuprofen EP impurity M CAS No.:60057-62-7 Molecular Formula:
Product Number:PCL-#-Ca043-50mg Carbol sulfonate sodium impurity 9 Product Name:Carbol sulfonate sodium impurity 9 CAS No.:70063-07-9 Molecular Formula:
Product Number:PCL-#-Bz0391-50mg Cefmetazole sodium catabolite II Product Name:Cefmetazole sodium catabolite II CAS No.:55817-29-3 Molecular Formula:
Product Number:PCL-#-Et374-50mg Ethyl 2-(1-imidazolyl)acetate Product Name:Ethyl 2-(1-imidazolyl)acetate CAS No.:17450-34-9 Molecular Formula:
Product Number:PCL-#-Li003-50mg Linezolid impurity H Product Name:Linezolid impurity H CAS No.:333753-69-8 Molecular Formula:
Product Number:PCL-#-Pr025-50mg Pranoprofen impurity I Product Name:Pranoprofen impurity I CAS No.:52549-44-7 Molecular Formula:
Product Number:PCL-#-Ap105-100mg Atropine sulfate impurity G Product Name:Atropine sulfate impurity G CAS No.:21956-47-8 Molecular Formula:
Product Number:PCL-#-Bz0122-50mg Terbutaline impurity 6 Product Name:Terbutaline impurity 6 CAS No.:882066-15-1 Molecular Formula:
Product Number:PCL-#-Az532-25mg Azithromycin EP impurity H; Azithromycin impurity III (impurity H) 3'-N-[[4-(acetylamino)phenyl]sulfonyl]-3'-N-desmethyl azithromycin Product Name:Azithromycin EP impurity H; Azithromycin impurity III (impurity H) 3'-N-[[4-(acetylamino)phenyl]sulfonyl]-3'-N-desmethyl azithromycin CAS No.:612069-30-4 Molecular Formula:
Product Number:PCL-#-Chp0125-50mg Zidoramidovudine tablets impurity V Salicylic acid Product Name:Zidoramidovudine tablets impurity V Salicylic acid CAS No.:69-72-7 Molecular Formula:
Product Number:PCL-#-Sc003-25mg Sodium carboxysulfonate impurity L Product Name:Sodium carboxysulfonate impurity L CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Qu008-100mg Quetiapine fumarate impurity H, Product Name:Quetiapine fumarate impurity H, CAS No.:1076199-40-0 Molecular Formula:
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