Industrial Purity Specifications & COA Standards for 3-Chloro-4-Fluoroaniline (CAS 367-21-5)
- Meets stringent industrial purity standards: ≥99.0% assay with single impurity ≤0.3%
- COA includes GC/HPLC validation, moisture content, residual solvents, and heavy metals
- Produced via optimized synthesis route ensuring batch-to-batch consistency for pharma & agrochemical applications
In the global fine chemical supply chain, 3-Chloro-4-fluoroaniline (CAS 367-21-5)—also known as 3-chloro-4-fluorobenzenamine or para-fluoro-meta-chloroaniline—is a critical building block for pharmaceutical intermediates, agrochemicals, and advanced materials. Its utility stems from the strategic positioning of chlorine and fluorine substituents on the aniline ring, enabling selective electrophilic substitution and cross-coupling reactions. However, its efficacy in downstream applications hinges entirely on rigorous quality control, particularly through comprehensive Certificates of Analysis (COA) that validate industrial purity and traceability.
Certificate of Analysis (COA): The Quality Assurance Backbone
A Certificate of Analysis for 3-Chloro-4-fluoroaniline is not merely a compliance document—it is a technical dossier that confirms the compound meets exacting specifications required by regulated industries. Leading manufacturers like NINGBO INNO PHARMCHEM CO.,LTD. provide COAs that include:
- Assay Purity (GC or HPLC): Typically ≥99.0%, verified by calibrated chromatographic methods
- Individual Impurity Profile: No single unknown impurity exceeding 0.3%
- Moisture Content (KF Titration): ≤0.2% to prevent hydrolysis or side reactions
- Residual Solvents (GC-FID): Compliant with ICH Q3C guidelines (e.g., toluene, DMF < 500 ppm)
- Heavy Metals (ICP-MS): Total metals ≤10 ppm, with strict limits on Pb, As, Cd, Hg
- Appearance & Physical State: Pale yellow to amber liquid or low-melting solid, free of particulates
When sourcing high-purity 3-Chloro-4-fluoroaniline, buyers must verify that the COA aligns with pharmacopeial standards (e.g., EP, USP) or internal quality thresholds, especially for use in active pharmaceutical ingredient (API) synthesis.
Industrial Purity Requirements Across Applications
The demand for ultra-pure Benzenamine 3-chloro-4-fluoro varies by sector, but all require tight control over molecular integrity:
Pharmaceutical Development
In API synthesis, even minor impurities can alter pharmacokinetics or trigger genotoxicity. Thus, industrial purity of ≥99.0% with documented impurity structures is non-negotiable. NINGBO INNO PHARMCHEM CO.,LTD. employs multi-stage crystallization and distillation in its manufacturing process to achieve this benchmark consistently.
Agricultural Chemicals
For herbicides and insecticides, cost-effective bulk supply must not compromise reactivity. Impurities can reduce yield in subsequent steps (e.g., diazotization or Suzuki coupling), making COA-backed consistency essential for large-scale production.
Dyes, Pigments & Material Science
Color strength and polymer stability depend on the absence of chromophoric impurities. Here, the synthesis route—typically nitration followed by selective reduction and halogenation—must be meticulously controlled to avoid isomeric byproducts like 2-chloro-4-fluoroaniline.
Technical Specifications & Batch Validation
Below is a representative specification table for high-grade 3-Chloro-4-fluoroaniline as supplied by NINGBO INNO PHARMCHEM CO.,LTD.:
| Parameter | Specification | Test Method |
|---|---|---|
| Chemical Name | 3-Chloro-4-fluoroaniline / 4-fluoro-3-chloro-aniline | IUPAC |
| CAS Number | 367-21-5 | - |
| Molecular Formula | C₆H₅ClFN | - |
| Assay (GC) | ≥99.0% | GC-FID, internal standard |
| Single Impurity | ≤0.3% | HPLC-UV |
| Moisture | ≤0.2% | Karl Fischer |
| Residue on Ignition | ≤0.1% | USP <281> |
| Heavy Metals | ≤10 ppm | ICP-MS |
| Packaging | Drums (200 kg) or IBC totes under N₂ | - |
Why Global Manufacturers Prioritize COA Transparency
As a top-tier global manufacturer, NINGBO INNO PHARMCHEM CO.,LTD. integrates real-time analytics into every production batch. Each lot of CHLOROFLUOROANILINE is assigned a unique batch number, enabling full traceability from raw material sourcing through final QC release. This ensures that clients receive not just a chemical, but a fully documented, audit-ready product compliant with REACH, TSCA, and FDA requirements.
For R&D labs and commercial producers alike, access to reliable COA data minimizes qualification timelines and accelerates regulatory filings. Whether used in novel kinase inhibitors or next-generation crop protection agents, the performance of 3-Chloro-4-fluoroaniline begins with uncompromising quality—validated, certified, and delivered at scale.