Determination of Moisture Content in Pharmaceutical Intermediate 3-Chloro-4-fluoroaniline

Reference standard: YY/T 0213-1995 Pharmaceutical Intermediate 3-Chloro-4-fluoroaniline

[Subject Matter and Scope of Application]

This standard specifies the technical requirements, test methods, inspection rules, packaging, labeling, transportation, and storage requirements for the pharmaceutical intermediate 3-chloro-4-fluoroaniline.

This standard applies to 3-chloro-4-fluoroaniline produced by chemical synthesis, which is used as an intermediate in the pharmaceutical industry for drugs such as norfloxacin.

Referenced standard: Pharmacopoeia of the People’s Republic of China, 2020 Edition, Volume IV, Method 0832 for Moisture Determination

Chemical name: 3-Chloro-4-fluoroaniline 3-chloro-4-fluoro aniline

Molecular formula: C ₈ H ₅ ClFN

Structural formula:

Molecular weight: 145.57

[Technical Requirements]

Trait: This product is a colorless to pale yellow to light brown crystal that gradually darkens in color when exposed to air. It is readily soluble in benzene and ethanol, but insoluble in water.

Projects and Indicators

[Experimental Method]

Determination of moisture content: Take an appropriate amount of sample and determine the moisture content according to Method 1 in Volume IV, Chapter 0832 of the 2020 Edition of the Chinese Pharmacopoeia.

[Recommended]

Karl Fischer Moisture Analyzer CA-310 Volumetric Method

Instrument features:

1. Higher detection accuracy: Under ideal conditions, it can detect trace amounts of moisture (absolute water content as low as 5 μg) with excellent repeatability.

2. The console can connect to up to 4 detection channels. Multiple channels provide better reference for experimental results and also enhance detection efficiency.

3. Standard Operating Procedure (S.O.P.) Recording: A standard operating procedure for testing a specific sample can be entered into the instrument. Subsequently, the instrument will automatically prompt the operator to perform the sample test according to the standard operating method.

Technical specifications:

Technical Specifications of the CA-310 Volumetric Micro Moisture Analyzer
Measurement method	Karls Fischer volumetric titration Simultaneous 4-channel measurement (optional)
Moisture determination range	0.1 ~ 999.999 mg H ₂ O
Display screen	8.4-inch color LCD touch screen, supports Chinese operation
File storage	Detailed experimental data storage: 9,999 entries Instrument timing start/stop setting options: 99 types
Printer	Optional thermal printer or impact printer.
Moisture vaporization device	Can be used with VA-300, VA-200, VA-210, VA-230, VA-236S, VA-121, and VA-122 gasification units all feature stepwise temperature control functionality.
Bromine detection mode Burette	Volume: 10 ml (2 ml, 5 ml, and 20 ml burettes available as optional accessories) Titration accuracy: 0.1% Reagent filling speed: 0.7 ml/1 sec
External Access I/O	Electronic balance: Automatic weight input 4 USB ports, 1 LAN port Import or export experimental data, backup/restore settings

Keywords:

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