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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-#-Bz0398-50mg ceftriaxone impurity B Product Name:ceftriaxone impurity B CAS No.:66340-33-8 Molecular Formula:
Product Number:PCL-#-Bz0131-50mg Doxophylline impurity 6 Product Name:Doxophylline impurity 6 CAS No.:1429636-72-5 Molecular Formula:
Product Number:PCL-#-Br044-20mg 2-(5-Bromoquinazolin-6-yl)guanidine (EP impurity E) Product Name:2-(5-Bromoquinazolin-6-yl)guanidine (EP impurity E) CAS No.:168329-48-4 Molecular Formula:
Product Number:PCL-#-Bz0030-50mg m-Hydroxylamine isomer 2 Product Name:m-Hydroxylamine isomer 2 CAS No.:21480-43-3 Molecular Formula:
Product Number:PCL-#-Bz0206-50mg Ezetimibe tetrahydropyran impurity Product Name:Ezetimibe tetrahydropyran impurity CAS No.:1296129-15-1 Molecular Formula:
Product Number:PCL-#-Bz0159-50mg Ketoconazole Product Name:Ketoconazole CAS No.:65277-42-1 Molecular Formula:
Product Number:PCL-#-Mo125-1g Mosapride Product Name:Mosapride CAS No.:112885-41-3 Molecular Formula:
Product Number:PCL-#-Bu243-50mg Butyl chloroformate Product Name:Butyl chloroformate CAS No.:592-34-7 Molecular Formula:
Product Number:PCL-#-Li332-100mg Ritastat impurity R Product Name:Ritastat impurity R CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Cp104-50mg Clindamycin Phosphate Impurity G(2,4-phosphoryl ester lincomycin) Product Name:Clindamycin Phosphate Impurity G(2,4-phosphoryl ester lincomycin) CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Me084-100mg 1-[2-Amino-1-(4-methoxyphenyl)ethyl]cyclohexanol (venlafaxine hydrochloride IM01); venlafaxine EP impurity C Product Name:1-[2-Amino-1-(4-methoxyphenyl)ethyl]cyclohexanol (venlafaxine hydrochloride IM01); venlafaxine EP impurity C CAS No.:93413-77-5 Molecular Formula:
Product Number:PCL-#-Bz0413-50mg Vildagliptin impurity R Product Name:Vildagliptin impurity R CAS No.:1803168-09-3 Molecular Formula:
Product Number:PCL-#-Ri013-50mg Ritonavir Impurity 06 Product Name:Ritonavir Impurity 06 CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Ra020-50mg Racemic Cardotril impurity G Product Name:Racemic Cardotril impurity G CAS No.:81110-69-2 Molecular Formula:
Product Number:PCL-#-Cp108-50mg Clindamycin Phosphate EP Impurity H,Clindamycin Phosphate Impurity H(Clindamycin 2,3-diphosphate) Product Name:Clindamycin Phosphate EP Impurity H,Clindamycin Phosphate Impurity H(Clindamycin 2,3-diphosphate) CAS No.:N/A Molecular Formula:
Product Number:PCL-#-De006-50mg Donepezil indene (dehydrodeoxydonepezil (donepezil hydrochloride impurity H)) Product Name:Donepezil indene (dehydrodeoxydonepezil (donepezil hydrochloride impurity H)) CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Br043-20mg 5-Bromoquinazolin-6-ylthiourea (EP impurity D) Product Name:5-Bromoquinazolin-6-ylthiourea (EP impurity D) CAS No.:842138-74-3 Molecular Formula:
Product Number:PCL-#-Fu007-25mg Furosemide EP impurity E, Product Name:Furosemide EP impurity E, CAS No.:50-84-0 Molecular Formula:
Product Number:PCL-#-Gu002-50mg Guanfacine hydrochloride impurity B (2,6-dichlorophenylacetic acid) Product Name:Guanfacine hydrochloride impurity B (2,6-dichlorophenylacetic acid) CAS No.:6575-24-2 Molecular Formula:
Product Number:PCL-#-Bz0072-50mg Atorvastatin impurity 7 Product Name:Atorvastatin impurity 7 CAS No.:125971-94-0 Molecular Formula:
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