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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:

Method design: Based on ChP, WHO guidelines, and ICH Q4B.
Material synthesis: High-purity raw materials processed via advanced chromatography (e.g., preparative HPLC).
Characterization: Multi-laboratory validation using NMR, mass spectrometry, and thermal analysis.
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	Product Name	CAS No.	Molecular Formula
Product Number:800009	Product Name:Listeria monocytogenes for food testing	CAS No.:#	Molecular Formula:
Product Number:800008	Product Name:Cronobacter sakazakii for food testing	CAS No.:#	Molecular Formula:
Product Number:510112	Product Name:pantoprazole sodium impurity B	CAS No.:#	Molecular Formula:
Product Number:101133	Product Name:Difenidol hydrochloride impurity (ene compound)	CAS No.:101133-N/A	Molecular Formula:
Product Number:510113	Product Name:pantoprazole sodium impurity C	CAS No.:#	Molecular Formula:
Product Number:101132	Product Name:Etomidate	CAS No.:101132-N/A	Molecular Formula:
Product Number:101131	Product Name:Amiloride hydrochloride impurity (4-amino-6-chloro-1,3-phenyl disulfide)	CAS No.:101131-N/A	Molecular Formula:
Product Number:510111	Product Name:pantoprazole sodium impurity A	CAS No.:#	Molecular Formula:
Product Number:101130	Product Name:Riclamin hydrobromide	CAS No.:101130-N/A	Molecular Formula:
Product Number:101159	Product Name:Sodium p-aminosalicylate	CAS No.:6018-19-5	Molecular Formula:
Product Number:140766	Product Name:Cyclo-(L-alanyl-L-glutamic acid)	CAS No.:#	Molecular Formula:
Product Number:101158	Product Name:Nisoldipine Impurity II	CAS No.:101158-N/A	Molecular Formula:
Product Number:140765	Product Name:L-alanyl-L-glutamic acid	CAS No.:13187-90-1	Molecular Formula:
Product Number:101157	Product Name:Nisoldipine impurity I (methyl isobutyl 2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylate)	CAS No.:101157-N/A	Molecular Formula:
Product Number:140764	Product Name:D-alanyl-L-glutamine	CAS No.:205252-36-4	Molecular Formula:
Product Number:101156	Product Name:Nimodipine impurity Ⅰ (2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid-2-methoxyethyl isopropyl ester)	CAS No.:101156-N/A	Molecular Formula:
Product Number:140762	Product Name:L-pyroglutamyl-L-alanine	CAS No.:21282-08-6	Molecular Formula:
Product Number:140761	Product Name:Cyclo-(L-alanyl-L-glutamine)	CAS No.:#	Molecular Formula:
Product Number:101166	Product Name:FURANTOIN	CAS No.:67-20-9	Molecular Formula:
Product Number:101165	Product Name:Leflunomide impurity II{2-cyano-3-hydroxy-N-[4′-(trifluoromethyl)phenyl]but-2-en-amide}	CAS No.:101165-N/A	Molecular Formula: