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Reference materials from the National Institutes for Food and Drug Control (NIFDC)

1. Definition and Significance of NIFDC Reference Standards

NIFDC reference standards are specialized materials prepared, characterized, and supplied by the National Institutes for Food and Drug Control (NIFDC) under China’s State Drug Administration. As a WHO-designated Collaborating Centre for Drug Quality Assurance, NIFDC’s standards are integral to national drug regulations. They serve as authoritative benchmarks for:

  • Drug identification: Distinguishing genuine vs. counterfeit products.
  • Purity and content analysis: Quantifying active ingredients and impurities.
  • Instrument calibration: Validating HPLC, GC-MS, and spectrophotometer performance.

These standards align with both ChP and international pharmacopeias (USP, EP), bridging global quality requirements.

2. Categories and Sources

NIFDC reference materials cover three core domains:

  • Chemical drugs: e.g., impurity standards, residual solvent kits.
  • Biopharmaceuticals: e.g., peptide/protein reference materials.
  • Traditional Chinese Medicine (TCM): e.g., herbal authentication markers.

Sources:

  • Domestic development: Rigorously validated in NIFDC’s ISO 17025-accredited labs.
  • International collaboration: Cross-certified with USP, EP, and WHO standards.

3. Preparation and Characterization

NIFDC’s production follows a strict protocol:

  1. Method design: Based on ChP, WHO guidelines, and ICH Q4B.
  2. Material synthesis: High-purity raw materials processed via advanced chromatography (e.g., preparative HPLC).
  3. Characterization: Multi-laboratory validation using NMR, mass spectrometry, and thermal analysis.
  4. Stability testing: Accelerated aging studies to ensure 5-10-year shelf life.

Key metrics: Purity (≥98%), uncertainty (<0.5%), and traceability (ISO 17034).

4. Applications and Best Practices

Applications:

  • Pharmaceutical R&D: Impurity profiling for ANDA/NDA submissions.
  • GMP compliance: Batch release testing for APIs and finished products.
  • Regulatory audits: Supporting NMPA, FDA, and EMA inspections.

Usage guidelines:

  • Storage: -20°C for biologics; room temperature for chemical standards.
  • Calibration: Revalidate every 6 months or per method lifecycle.
  • Documentation: Lot-specific COA (Certificate of Analysis) available online.

Supplementary Information
For technical queries or custom reference standard requests, contact Hengyuan Fine Chemical.


Henyuan Fine Chemical is a leading Chinese supplier specializing in pharmaceutical and biological testing fields. As an authorized distributor of the PCL (Purechemland) product series, the company operates directly from manufacturers, serving pharmaceutical enterprises, research institutions, and third-party testing platforms.

Hengyuan Fine Chemical provides 3,000-4,000 types of NIFDC (National Institutes for Food and Drug Control) reference standards, covering chemical drugs, biologics, traditional Chinese medicines, and medical devices. All products are directly supplied or authorized by the China National Institutes for Food and Drug Control (NIFDC), strictly adhering to the Chinese Pharmacopoeia and international testing standards (e.g., USP, EP). The PCL series implements a full-process quality control system spanning cold-chain storage, precision packaging, and quality validation, ensuring the stability and traceability of reference materials. Additionally, the company offers customized solutions and technical consulting services to enhance clients' drug R&D efficiency, production compliance, and testing credibility, solidifying its position as a trusted industry benchmark for standardized services.


Product Number Image Product Name CAS No. Molecular Formula
Product Number:101333 Lamivudine impurity mixture Product Name:Lamivudine impurity mixture CAS No.:101333-N/A Molecular Formula:
Product Number:100002 Anacin Product Name:Anacin CAS No.:68-89-3 Molecular Formula:
Product Number:101332 Iodophorol impurity II (N,N'-bis(2,3-dihydroxypropyl)-5-(2-(2-hydroxyacetamido)-2-oxoethoxy)- 2,4,6-triiodo-1,3-benzenedicarboxamide) Product Name:Iodophorol impurity II (N,N'-bis(2,3-dihydroxypropyl)-5-(2-(2-hydroxyacetamido)-2-oxoethoxy)- 2,4,6-triiodo-1,3-benzenedicarboxamide) CAS No.:101332-N/A Molecular Formula:
Product Number:101342 Tropicamide impurityⅠ[N-(4-pyridinylmethyl)ethylamine] Product Name:Tropicamide impurityⅠ[N-(4-pyridinylmethyl)ethylamine] CAS No.:101342-N/A Molecular Formula:
Product Number:100011 Chlormadinone acetate Product Name:Chlormadinone acetate CAS No.:100011-N/A Molecular Formula:
Product Number:101341 Piperaquine phosphate impurity III [1,4bis(7-chloro-quinolin-4-yl)piperazine] Product Name:Piperaquine phosphate impurity III [1,4bis(7-chloro-quinolin-4-yl)piperazine] CAS No.:101341-N/A Molecular Formula:
Product Number:100009 Fludrocortisone acetate Product Name:Fludrocortisone acetate CAS No.:100009-N/A Molecular Formula:
Product Number:101340 Piperaquine phosphate impurity II (7-chloro-4-hydroxyquinoline) Product Name:Piperaquine phosphate impurity II (7-chloro-4-hydroxyquinoline) CAS No.:101340-N/A Molecular Formula:
Product Number:101328 Emtricitabine Impurity V ((2R,5S)-5-(5-fluorocytosine-1-yl)-1,3-oxathiolane-2-carboxylic acid menthol ester) Product Name:Emtricitabine Impurity V ((2R,5S)-5-(5-fluorocytosine-1-yl)-1,3-oxathiolane-2-carboxylic acid menthol ester) CAS No.:101328-N/A Molecular Formula:
Product Number:101327 Emtricitabine impurity IV Product Name:Emtricitabine impurity IV CAS No.:101327-N/A Molecular Formula:
Product Number:101326 Emtricitabine Impurity II [(2R,3R,5S)-5-fluoro-1-[2-hydroxymethyl-3-oxo-1,3-oxathiolan-5-yl]cytosine] Product Name:Emtricitabine Impurity II [(2R,3R,5S)-5-fluoro-1-[2-hydroxymethyl-3-oxo-1,3-oxathiolan-5-yl]cytosine] CAS No.:101326-N/A Molecular Formula:
Product Number:101325 Aplindin hydrochloride Product Name:Aplindin hydrochloride CAS No.:101325-N/A Molecular Formula:
Product Number:101324 Artemether impurity II {2-[4-methyl-2-oxo-3-(3-oxobutyl)cyclohexyl]propionaldehyde} Product Name:Artemether impurity II {2-[4-methyl-2-oxo-3-(3-oxobutyl)cyclohexyl]propionaldehyde} CAS No.:101324-N/A Molecular Formula:
Product Number:101323 alpha-artemether Product Name:alpha-artemether CAS No.:71939-51-0 Molecular Formula:
Product Number:101322 Benfluorenol impurity Ι｛(RS,Z)-2-(dibutylamino)-2-[2,7-dichloro-9-(4-chlorophenylmethylene)9H-fluoren-4-yl]ethanol }} Product Name:Benfluorenol impurity Ι｛(RS,Z)-2-(dibutylamino)-2-[2,7-dichloro-9-(4-chlorophenylmethylene)9H-fluoren-4-yl]ethanol }} CAS No.:101322-N/A Molecular Formula:
Product Number:101321 Benfluorenol Product Name:Benfluorenol CAS No.:101321-N/A Molecular Formula:
Product Number:101329 Emtricitabine Isomer Check System Suitability Test Mixture Product Name:Emtricitabine Isomer Check System Suitability Test Mixture CAS No.:101329-N/A Molecular Formula:
Product Number:101331 Iodophorol impurity I (N,N'-bis(2,3-dihydroxypropyl)-5-amino-2,4,6-triiodo-1,3-benzenedicarboxamide) Product Name:Iodophorol impurity I (N,N'-bis(2,3-dihydroxypropyl)-5-amino-2,4,6-triiodo-1,3-benzenedicarboxamide) CAS No.:101331-N/A Molecular Formula:
Product Number:101330 iophorol Product Name:iophorol CAS No.:101330-N/A Molecular Formula:
Product Number:100029 menaquinone Product Name:menaquinone CAS No.:58-27-5 Molecular Formula:
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