HOGON MT-V6 Automatic Potentiometric Titrator for Clenbuterol Hydrochloride Content Determination
| Brand | HOGON |
|---|---|
| Origin | Shanghai, China |
| Manufacturer | HOGON Scientific Instruments Co., Ltd. |
| Type | Universal Automatic Potentiometric Titrator |
| Application Scope | General-purpose |
| pH Range | 0.000–14.000, Resolution: 0.001 pH |
| mV Accuracy | ±0.1 mV |
| mV Resolution | 0.1 mV |
| Burette Precision | 20 mL standard burette (1 µL increment), 10 mL optional burette (0.5 µL increment) |
| mV Input Range | ±2000 mV, Resolution: 0.1 mV |
Overview
The HOGON MT-V6 Automatic Potentiometric Titrator is a dedicated analytical platform engineered for high-reproducibility quantitative determination of clenbuterol hydrochloride — a β₂-adrenergic agonist widely used in respiratory therapeutics and subject to strict pharmacopeial control. Unlike generic titrators, the MT-V6 integrates a purpose-configured amperometric (dead-stop) titration module optimized for the diazotization-coupling reaction between clenbuterol hydrochloride and sodium nitrite under acidic conditions. This electrochemical endpoint detection method relies on real-time monitoring of current flow across dual platinum microelectrodes, enabling unambiguous identification of the stoichiometric equivalence point without reliance on visual indicators or derivative-based pH inflection analysis. The instrument adheres to core principles of potentiometric and amperometric titrimetry as defined in ISO 8587:2006 and USP , with hardware architecture designed to meet GLP-compliant data integrity requirements.
Key Features
- Dual-platinum amperometric sensor system with low-noise signal conditioning circuitry, delivering stable baseline current measurement and sub-microampere endpoint resolution.
- High-precision 20 mL glass burette (±1 µL dispensing resolution) calibrated per ISO 8655-3, with optional 10 mL burette (±0.5 µL) for trace-level titrant delivery.
- Programmable titration parameters including minimum/maximum incremental volume (50 µL default), stirrer speed (adjustable 0–120 rpm; 30 rpm recommended for homogeneous diazotization), and inter-drop delay (2000 ms) to ensure complete reaction kinetics before potential sampling.
- Integrated pH/mV meter with 0.001 pH resolution and ±0.1 mV absolute accuracy across ±2000 mV range, compliant with IEC 60746-1 for electrochemical instrumentation.
- 100 mL PTFE-coated titration vessel with magnetic stirring and gas-tight lid interface, minimizing NO gas loss during nitrous acid generation and preventing atmospheric interference.
Sample Compatibility & Compliance
The MT-V6 supports aqueous and partially miscible organic-aqueous matrices typical of pharmaceutical raw material and dosage form extracts (e.g., HCl-dissolved clenbuterol samples in 10% v/v acetic acid). It complies with pharmacopeial methodologies described in Chinese Pharmacopoeia (ChP) Volume II, Section 0401 (Potentiometric Titration), and aligns with validation requirements of ICH Q2(R2) for assay procedures. Instrument qualification includes factory-installed IQ/OQ documentation, and its audit trail functionality satisfies FDA 21 CFR Part 11 criteria for electronic records when operated with HOGON’s certified software suite. All wetted components are chemically resistant to nitrous acid, sodium nitrite, and hydrochloric acid solutions.
Software & Data Management
The proprietary HOGON TitraSoft™ v3.2 software provides full method development, sequence automation, and GLP-compliant data handling. Each titration run automatically logs timestamped electrode potential, current, burette position, stirrer speed, ambient temperature/humidity (via optional external probe), and user ID. Raw data files are stored in encrypted .hdt binary format with SHA-256 checksums; export options include CSV, PDF reports with embedded chromatogram-style titration curves, and XML for LIMS integration. Audit trail records all parameter modifications, result deletions, and reprocessing events with immutable timestamps and operator attribution — fully traceable for regulatory inspection.
Applications
Beyond clenbuterol hydrochloride quantification in APIs and finished products, the MT-V6 serves validated applications in: (1) assay of other primary aromatic amines (e.g., procaine, sulfadiazine); (2) redox titrations involving Ce⁴⁺/Fe²⁺ or KMnO₄ systems; (3) argentometric determination of halides; and (4) acid-base titrations requiring sub-pH-unit resolution in non-aqueous media. Its modular design permits rapid reconfiguration between amperometric, potentiometric, conductometric, and thermometric modes via firmware-selectable electrode interfaces and algorithm libraries.
FAQ
What electrochemical principle does the MT-V6 use for clenbuterol hydrochloride assay?
It employs amperometric (dead-stop) detection during sodium nitrite-mediated diazotization, measuring current interruption at the equivalence point via dual platinum electrodes.
Is the instrument compliant with FDA 21 CFR Part 11 for electronic records?
Yes — when used with TitraSoft™ v3.2 and enabled audit trail, electronic signatures, and role-based access control.
Can the MT-V6 perform multiple titration modes beyond amperometry?
Yes — it supports potentiometric, conductometric, and thermometric titration through interchangeable electrode modules and firmware configuration.
What calibration standards are required for routine operation?
NIST-traceable pH buffer solutions (pH 4.01, 7.00, 10.01) and certified mV reference solutions (e.g., ±100 mV, ±500 mV) are recommended biweekly; burette volumetric calibration follows ISO 8655-3 using gravimetric water delivery.
How is method transfer supported between laboratories?
Method files (.hmf) encapsulate all parameters, electrode definitions, endpoint algorithms, and report templates — enabling direct import/export across MT-V6 units without revalidation of core settings.
