Safety testing system C850M

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The C850M Integrated water‑insoluble matter testing system is an automated gravimetric analyzer for detection of water‑insoluble matter in chemical reagents and pharmaceutical excipients. It automates dissolution, filtration, washing, drying and weighing to support traceable results and optional GMP/21 CFR Part 11 compliance.

Characteristics
Traceable data

• Fully automatic manipulator for rapid handling and weighing of 12 test crucibles, enabling traceable measurements.
• Dual‑chamber design separates evaporation and weighing to prevent high temperature and humidity from affecting the balance.
• High‑precision electronic balance with optional repeatability to 0.05 mg; balance visible through an observation panel and removable for calibration with standard weights.
• Quick‑release balance for simplified maintenance and calibration.

Safe & compliant

• Fully enclosed, zero‑leakage water bath to prevent harmful gas escape.
• Automatic filter residue cleaning and drainage to reduce manual intervention.
• Rapid liquid cooling system to enable room‑temperature weighing and minimize thermal disturbance.
• Nitrogen purge cycling and independent electrical control for safer testing with hazardous gases.
• Condensate recovery system to limit environmental discharge.

Intelligent control

• 10.1" medical‑grade touchscreen; instrument operates independently without a PC.
• Desktop mainframe to save bench space; automated sequences for washing, drying, cooling and room‑temperature weighing.
• Multiple sensors and audible/visual alarms for operator safety.
• Network port for remote control and firmware upgrades.
• Professional software supporting data traceability, multi‑level user management and optional electronic signature per 21 CFR Part 11.

Testing principle
The sample is dissolved in water, insoluble matter is retained on a filter, the residue is washed, dried and weighed. The gravimetric result determines the amount of water‑insoluble matter.

Test standard compliance

• Designed to meet GB/T 9738 and other relevant standards for water‑insoluble matter testing in chemical reagents and pharmaceutical excipients.

Applications

• Chemical reagents: Determination of water‑insoluble matter in various reagents.
• Pharmaceutical excipients: Determination of water‑insoluble matter in excipient materials.

Technical specifications (key)

• Model: C850M
• Test range (mg): 0.3 – 80,000; optional 0.05 – 10,000
• Resolution (mg): standard 0.1; optional 0.01
• Repeatability (mg): standard ±0.3; optional ±0.05
• Temperature range: room temperature – 130 °C
• Temperature fluctuation: ±0.5 °C
• Extended functions (optional): 21 CFR Part 11; GMP computer system support
• Test stations: 12
• Glass filter crucible volume: 100 mL (customizable)
• Glass filter crucible pore size: 5 μm – 15 μm (customizable)
• Gas specification: compressed air (user‑supplied)
• Gas source pressure: ≥ 72.5 PSI / 500 kPa
• Port size: Φ8 mm polyurethane tube
• Instrument dimensions: 24.8" H × 41.3" W × 28.7" D (63 cm × 105 cm × 73 cm)
• Power supply: 120 VAC ±10% 60 Hz or 220 VAC ±10% 50 Hz
• Net weight: 396 lbs (180 kg)
• Standard configuration: mainframe with balance (0.1 mg), electrical control module, reagent collection module, liquid cooling module, 12 glass filter crucibles, Φ8 mm polyurethane tube
• Optional parts: software, GMP computer system, 21 CFR Part 11 support, air compressor (>200 L/min exhaust), 100 mL glass filter crucibles, balance (0.01 mg), calibration weight (50 g)

Notes

• Glass crucible volume and pore size can be customized; this may affect the test range — final configuration governs capability.
• Manufacturer can provide custom production within capability to meet special requirements; specifications and functions are subject to change and final delivery.