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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-#-Ai104-50mg Aripiprazole EP impurity D Product Name:Aripiprazole EP impurity D CAS No.:203395-82-8 Molecular Formula:
Product Number:PCL-#-Ol028-25mg Olopatadine impurity 10 Product Name:Olopatadine impurity 10 CAS No.:145126-87-0 Molecular Formula:
Product Number:PCL-#-Bd100-25mg 7-(4-Bromobutoxy)-3,4-dihydro-2(1H)-quinolinone Product Name:7-(4-Bromobutoxy)-3,4-dihydro-2(1H)-quinolinone CAS No.:129722-34-5 Molecular Formula:
Product Number:PCL-#-Bz0294-50mg Ertapenem USP impurity B/(S)-hydroxyproline aminobenzoic acid Product Name:Ertapenem USP impurity B/(S)-hydroxyproline aminobenzoic acid CAS No.:盐酸盐444057-62-9/266337-30-8游离 Molecular Formula:
Product Number:PCL-#-Gl003-20mg Glibenclamide impurity B Product Name:Glibenclamide impurity B CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0196-50mg Mannestrone Product Name:Mannestrone CAS No.:517-09-9 Molecular Formula:
Product Number:PCL-#-Va100-50mg Valproic acid EP impurity G Product Name:Valproic acid EP impurity G CAS No.:52061-73-1 Molecular Formula:
Product Number:PCL-#-Bz0382-50mg Propranolol impurity G Product Name:Propranolol impurity G CAS No.:1236367-67-1 Molecular Formula:
Product Number:PCL-#-Ve010-100mg Venlafaxine impurity IM01-C Product Name:Venlafaxine impurity IM01-C CAS No.:N/A Molecular Formula:
Product Number:PCL-#-Bz0450-50mg Ceftriaxone AE active ester (Type E) Product Name:Ceftriaxone AE active ester (Type E) CAS No.:1684396-27-7 Molecular Formula:
Product Number:PCL-#-Mo065-25mg Moxifloxacin impurity B Product Name:Moxifloxacin impurity B CAS No.:1029364-73-5 Molecular Formula:
Product Number:PCL-#-Pr151-50mg Pramipexole hydrochloride impurity F-1 Product Name:Pramipexole hydrochloride impurity F-1 CAS No.:104617-51-8 Molecular Formula:
Product Number:PCL-#-Bz0180-50mg 5-acetyl-2,2-dimethyl-1,3-dioxane-4,6-dione Product Name:5-acetyl-2,2-dimethyl-1,3-dioxane-4,6-dione CAS No.:72324-39-1 Molecular Formula:
Product Number:PCL-#-Az539-50mg Azithromycin impurity IV (impurity I) [Azithromycin I (3'-N-desmethylazithromycin] (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[[2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribulose-cohexylglycopyranosidyl]oxy]-2-ethyl-3,4,10-trihydroxy-3. 5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-methylamino-beta-D-xylulose-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one Product Name:Azithromycin impurity IV (impurity I) [Azithromycin I (3'-N-desmethylazithromycin] (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[[2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribulose-cohexylglycopyranosidyl]oxy]-2-ethyl-3,4,10-trihydroxy-3. 5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-methylamino-beta-D-xylulose-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one CAS No.:172617-84-4 Molecular Formula:
Product Number:PCL-#-Bz0078-50mg Atorvastatin impurity 14 Product Name:Atorvastatin impurity 14 CAS No.:693793-82-7 Molecular Formula:
Product Number:PCL-#-Bz0264-50mg Ethyl glycodeoxycholate Product Name:Ethyl glycodeoxycholate CAS No.:70779-06-5 Molecular Formula:
Product Number:PCL-#-Pr001-25mg Pramipexole EP impurity C (6S,6'S)-N6,N6'-(2-methylpentane-1,3-diyl)bis(4,5,6,7-tetrahydrobenzothiazole)-2,6-diamine Product Name:Pramipexole EP impurity C (6S,6'S)-N6,N6'-(2-methylpentane-1,3-diyl)bis(4,5,6,7-tetrahydrobenzothiazole)-2,6-diamine CAS No.:1973461-14-1 Molecular Formula:
Product Number:PCL-#-D033-25mg Aripiprazole Impurity II Product Name:Aripiprazole Impurity II CAS No.:129722-25-4 Molecular Formula:
Product Number:PCL-#-Et008-50mg Ethambutol EP impurity C Product Name:Ethambutol EP impurity C CAS No.:10054-05-4 Molecular Formula:
Product Number:PCL-#-Az556-50mg Azithromycin EP impurity L; Azithromycin nitrogen oxides Product Name:Azithromycin EP impurity L; Azithromycin nitrogen oxides CAS No.:90503-06-3 Molecular Formula:
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