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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-#-Mi009-100mg Miraperon impurity 9 (Impurity Reference 9) Product Name:Miraperon impurity 9 (Impurity Reference 9) CAS No.:1884646-38-1 Molecular Formula:
Product Number:PCL-#-Nm335-100mg Omeprazole sodium impurity ⅲ (CP); Esomeprazole sodium impurity ⅲ; 5- methoxy -2-[[(4- methoxy -3,5- dimethyl -2- pyridyl) methyl] sulfinyl ]-1- methylbenzimidazole and 6- methoxy -2-[[(4- methoxy -3,5- dimethyl- ... Product Name:Omeprazole sodium impurity ⅲ (CP); Esomeprazole sodium impurity ⅲ; 5- methoxy -2-[[(4- methoxy -3,5- dimethyl -2- pyridyl) methyl] sulfinyl ]-1- methylbenzimidazole and 6- methoxy -2-[[(4- methoxy -3,5- dimethyl- ... CAS No.:784143-42-6/89352-76-1 Molecular Formula:
Product Number:PCL-#-Az008-100mg Methyl 2-[2-(4- chlorophenyl) acetyl] benzoate (azelastine hydrochloride impurity SM3-I10 reference substance) Product Name:Methyl 2-[2-(4- chlorophenyl) acetyl] benzoate (azelastine hydrochloride impurity SM3-I10 reference substance) CAS No.:61653-04-1 Molecular Formula:
Product Number:PCL-#-Da166-50mg Esomeprazole sodium impurity Ⅱ1,4- dihydro -1-(5- methoxy -1H- benzimidazole -2- yl) -3,5- dimethyl -4- oxo -2- pyridinecarboxylic acid Product Name:Esomeprazole sodium impurity Ⅱ1,4- dihydro -1-(5- methoxy -1H- benzimidazole -2- yl) -3,5- dimethyl -4- oxo -2- pyridinecarboxylic acid CAS No.:1227380-90-6 Molecular Formula:
Product Number:PCL-#-Re0564-50mg Ethyl 2- formyl -3- oxopropionate Product Name:Ethyl 2- formyl -3- oxopropionate CAS No.:80370-42-9 Molecular Formula:
Product Number:PCL-#-Bz0031-50mg M-hydroxylamine isomer 3 Product Name:M-hydroxylamine isomer 3 CAS No.:4956-27-8 Molecular Formula:
Product Number:PCL-#-Z098-25mg Zopiclon Product Name:Zopiclon CAS No.:43200-80-2 Molecular Formula:
Product Number:PCL-#-De007-50mg Deoxydonepezil (donepezil impurity I) Product Name:Deoxydonepezil (donepezil impurity I) CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Os105-100mg (3R, 4R, 5S)-4- acetamido -5- amino -3- (sec-butoxy) cyclohexyl -1- ene -1- carboxylate; Oseltamivir EP impurity f Product Name:(3R, 4R, 5S)-4- acetamido -5- amino -3- (sec-butoxy) cyclohexyl -1- ene -1- carboxylate; Oseltamivir EP impurity f CAS No.:1052063-37-2 Molecular Formula:
Product Number:PCL-#-Pe030-20mg Pemetrexed EP impurity a Product Name:Pemetrexed EP impurity a CAS No.:869791-42-4 Molecular Formula:
Product Number:PCL-#-Rf100-100mg (5R)-3-[3- fluoro -4-(4- morpholinyl) phenyl ]-5- hydroxymethyl -2- oxazolidinone Product Name:(5R)-3-[3- fluoro -4-(4- morpholinyl) phenyl ]-5- hydroxymethyl -2- oxazolidinone CAS No.:168828-82-8 Molecular Formula:
Product Number:PCL-#-Es472-50mg Dexzopiclone Product Name:Dexzopiclone CAS No.:138729-47-2 Molecular Formula:
Product Number:PCL-#-Ri101-50mg Acetaminophen impurity L Product Name:Acetaminophen impurity L CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Ph105-50mg Phenoxymethylpenicillin EP impurity F (diastereomeric mixture); (4S)-5,5-dimethyl-2-((2-phenoxyacetamido)methyl)thiazolidine-4-carboxylic acid; (Penicillin V potassium impurity F) Product Name:Phenoxymethylpenicillin EP impurity F (diastereomeric mixture); (4S)-5,5-dimethyl-2-((2-phenoxyacetamido)methyl)thiazolidine-4-carboxylic acid; (Penicillin V potassium impurity F) CAS No.:PCL-#-Ph105-N/A Molecular Formula:
Product Number:PCL-#-Di352-100mg (+)-(6R)-2,6-Diamino-4,5,6,7-tetrahydrobenzothiazole;Pramipexole impurity 43 Product Name:(+)-(6R)-2,6-Diamino-4,5,6,7-tetrahydrobenzothiazole;Pramipexole impurity 43 CAS No.:106092-11-9 Molecular Formula:
Product Number:PCL-#-Pr153-50mg Pramipexole hydrochloride impurity I Product Name:Pramipexole hydrochloride impurity I CAS No.:N/A Molecular Formula:
Product Number:PCL-#-De025-50mg Dexamethasone impurity 2 Product Name:Dexamethasone impurity 2 CAS No.:84449-15-0 Molecular Formula:
Product Number:PCL-#-Fu004-25mg Furosemide EP impurity B Product Name:Furosemide EP impurity B CAS No.:2736-23-4 Molecular Formula:
Product Number:PCL-#-Pr022-50mg Pranoprofen impurity F Product Name:Pranoprofen impurity F CAS No.:N/A Molecular Formula:
Product Number:PCL-#-AZ0919-50mg Azithromycin EP impurity G Product Name:Azithromycin EP impurity G CAS No.:612069-31-5 Molecular Formula:
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