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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-#-Tr043-50mg Lipoic acid impurity a Product Name:Lipoic acid impurity a CAS No.:1204245-29-3 Molecular Formula:
Product Number:PCL-#-Az534-50mg Azithromycin EP impurity n Product Name:Azithromycin EP impurity n CAS No.:612069-25-7 Molecular Formula:
Product Number:PCL-#-Vo005-50mg Vothioxetine hydrobromide impurity l; Vothioxetine hydrobromide impurity l; 1-[(2- bromophenyl) thio ]-2,4- dimethylbenzene Product Name:Vothioxetine hydrobromide impurity l; Vothioxetine hydrobromide impurity l; 1-[(2- bromophenyl) thio ]-2,4- dimethylbenzene CAS No.:960203-41-2 Molecular Formula:
Product Number:PCL-#-Bz0129-50mg Theophylline EP impurity d Product Name:Theophylline EP impurity d CAS No.:6736-40-9 Molecular Formula:
Product Number:PCL-#-Bz0063-50mg Propanecaine impurity 1 Product Name:Propanecaine impurity 1 CAS No.:59691-14-4 Molecular Formula:
Product Number:PCL-#-Bz0293-50mg Ertapenem dimethylamine Product Name:Ertapenem dimethylamine CAS No.:444057-65-2 Molecular Formula:
Product Number:PCL-#-To002-100mg Torvaltib citrate Product Name:Torvaltib citrate CAS No.:477600-75-2 Molecular Formula:
Product Number:PCL-#-Bz0324-50mg Terazofamide phosphate pyrophosphate impurity SL Product Name:Terazofamide phosphate pyrophosphate impurity SL CAS No.:1239662-48-6 Molecular Formula:
Product Number:PCL-#-Si003-100mg Sildenafil impurity 22 Product Name:Sildenafil impurity 22 CAS No.:200575-15-1 Molecular Formula:
Product Number:PCL-#-Pa102-50mg Phenoxyacetic acid; Phenoxymethyl penicillin EP impurity b Product Name:Phenoxyacetic acid; Phenoxymethyl penicillin EP impurity b CAS No.:122-59-8 Molecular Formula:
Product Number:PCL-#-Ma072-50mg Captopril impurity c; 3- mercaptoisobutyric acid Product Name:Captopril impurity c; 3- mercaptoisobutyric acid CAS No.:26473-47-2 Molecular Formula:
Product Number:PCL-#-Am108-100mg 1,3- Dimethyl -6- Imino -5- Isonitrosourea (Dimethyl Violet Acid) Product Name:1,3- Dimethyl -6- Imino -5- Isonitrosourea (Dimethyl Violet Acid) CAS No.:6632-68-4 Molecular Formula:
Product Number:PCL-#-Az001-100mg 4-[(2- ethoxycarbonyl-ethyl)-methylamino]-ethyl butyrate (azelastine hydrochloride impurity SM1-I9 reference substance) Product Name:4-[(2- ethoxycarbonyl-ethyl)-methylamino]-ethyl butyrate (azelastine hydrochloride impurity SM1-I9 reference substance) CAS No.:109386-70-1 Molecular Formula:
Product Number:PCL-#-H431-50mg methyl palmitate Product Name:methyl palmitate CAS No.:112-39-0 Molecular Formula:
Product Number:PCL-#-Bz0151-50mg Caffeine EP impurity E hydrochloride Product Name:Caffeine EP impurity E hydrochloride CAS No.:20041-90-1 Molecular Formula:
Product Number:PCL-#-Su0311-100mg N-ethyl-2-aminomethylpyrrolidine; Sulpiride EP impurity A Product Name:N-ethyl-2-aminomethylpyrrolidine; Sulpiride EP impurity A CAS No.:26116-12-1 Molecular Formula:
Product Number:PCL-#-Bz0207-50mg 4-(trifluoromethyl)benzenepropanol Product Name:4-(trifluoromethyl)benzenepropanol CAS No.:180635-74-9 Molecular Formula:
Product Number:PCL-#-Fl081-100mg 2-methoxy-5-fluorouracil Product Name:2-methoxy-5-fluorouracil CAS No.:1480-96-2 Molecular Formula:
Product Number:PCL-#-Bz0412-50mg Vildagliptin impurity F Product Name:Vildagliptin impurity F CAS No.:1789703-36-1 Molecular Formula:
Product Number:PCL-#-Bz0321-50mg ribavirin starting material 1 - impurity C Product Name:ribavirin starting material 1 - impurity C CAS No.:30747-23-0 Molecular Formula:
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