Physicochemical Analysis Platform

Physicochemical Analysis Platform

PharmaAnalytica has established a comprehensive, compliant routine Physical and Chemical Analysis Platform equipped with high-performance instruments, fully meeting pharmacopeial requirements for pharmaceutical quality control. The platform supports full-coverage detection of physical and chemical properties for APIs, excipients and finished pharmaceutical products, ensuring accurate, stable and traceable test results.

Dissolution & Release Testing

RCZ-12A Intelligent Dissolution Tester

  • Features

12-vessel 12-shaft configuration, paddle-basket coaxial design, independent real-time temperature measurement for each vessel with precision ±0.1℃, rotation speed deviation ≤±1%, low oscillation amplitude. It supports manual & automatic simultaneous dosing, auto sampling positioning, and sealed anti-evaporation caps to reduce medium volatilization. Built-in three-level user authority management, audit trail, and data integrity functions, fully compliant with USP and mechanical validation guidelines, and supports IQ/OQ certification documentation.

  • Applications

Dissolution rate testing for tablets, capsules; release profile testing for extended‑release, controlled‑release formulations; in vitro release evaluation and consistency assessment.

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RCZ-8N Intelligent Dissolution Tester

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  • Features

8-channel high-performance dissolution system, fully compliant with USP and consistency evaluation standards. Equipped with high-precision thermostatic control, dual over-temperature protection, automatic centering of dissolution vessels and stirrers, and supports basket method, paddle method, small-cup method and other pharmacopeial methods. Features manual synchronous dosing, user authority management, audit trail, data storage & USB export, ensuring test accuracy and data traceability.

  • Applications

Routine dissolution testing of oral solid preparations; formulation screening; quality consistency evaluation; compliance testing in pharmaceutical R&D and quality control.

Disintegration, Friability & Hardness Analysis

SY-6DN Intelligent Tablet Four-Usage Tester

  • Features

This integrated tester combines disintegration, friability, hardness and dissolution detection in one unit, with high-precision sensors, stable operation and user-friendly operation interface. It features accurate hardness measurement (10–350 N), automatic timing for disintegration, standard cylinder for friability test, and 6-channel dissolution measurement. The system supports programmable parameter settings, data storage, and full compliance with pharmacopoeial requirements for oral solid dosage forms.

  • Applications

Determination of disintegration time limit, friability, crushing hardness and dissolution of tablets and capsules; widely used for formulation optimization, quality control and consistency evaluation of solid preparations.

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Moisture, Loss on Drying, pH & Osmolality

PHSJ-6L Laboratory pH Meter

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  • Features

High resolution (0.001 pH), automatic temperature compensation, multi‑point calibration, GLP data management; suitable for solutions, suspensions and semi‑solids.

  • Applications

pH testing of injections, oral liquids, creams and gels.

SFK-506VC Karl Fischer Moisture Titrator

  • Features

SFK-506VC integrates both volumetric Karl Fischer method and coulometric Karl Fischer method in one unit, supporting direct measurement and Karl Fischer oven sampling mode to cover both macro and trace moisture detection. Measurement units including μg, mg, %, ppm, μg/L and mg/L are available, with data storage up to 2000 sets for volumetric and coulometric methods respectively. Communication via WLAN, USB and RS-232 is supported, enabling data export in CSV or PDF format and connection with printers, balances and Karl Fischer ovens.

  • Applications

Specific and accurate water content determination for APIs, excipients, finished pharmaceutical products, injections, raw materials and complex samples, fully complying with pharmacopeial requirements for moisture testing.

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SFS-101J Halogen Moisture Analyzer

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  • Features

SFS-101J adopts a high-efficiency annular halogen heating device, enabling rapid and uniform drying of samples within a temperature range from room temperature to 200°C. It provides three heating modes: standard drying, fast drying and slow drying, as well as three measuring modes: automatic measurement, continuous measurement and timed measurement (0–90 min). The instrument displays real-time temperature, heating duration and moisture results, and supports multiple result display modes including moisture content (M%), dry matter content (D%), ATRO moisture content (AM%) and ATRO wet basis (AD%).

  • Applications

Rapid determination of loss on drying (LOD) for APIs, excipients, raw materials and solid preparations, providing efficient data support for daily quality control and raw material incoming inspection.

STY-1A Osmometer

  • Features

Freezing point depression method, measurement range 0–3000 mOsmol/kg, low sample consumption, dual semiconductor cooling, high repeatability, compliant with USP requirements for injections.

  • Applications

Osmolality testing for injections, eye drops and biological fluids.

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Melting Point, Viscosity & Optical Rotation

RY-1G Automatic Melting Point Apparatus

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  • Features

Capillary method, electronic heating, visual observation with magnifier, temperature resolution ±0.1℃, cost‑effective and stable.

  • Applications

Melting point measurement for APIs and solid raw materials; crystal property evaluation.

NDJ-8S Digital Viscometer

  • Features

Wide viscosity range, multiple rotors, temperature matching, automatic measurement, high repeatability.

  • Applications

Viscosity testing of solutions, syrups, creams, gels and semi-solid preparations.

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SGW®-568A Automatic High-Speed Polarimeter

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  • Features

Delivers accuracy of ±0.003°, readability of 0.0001°, and excellent reproducibility (≤0.002°). Built-in 10–50°C thermostat for temperature-dependent optical rotation tests. GMP/21 CFR Part 11 compliant.

  • Applications

Specific rotation, optical purity, chiral API/excipient QC, stability monitoring.

Particle Contamination & Clarity

GWJ-8 Subvisible Particle Counter

  • Features

Laser light obscuration, 1–400 μm range, 8 channels, excellent repeatability (RSD<2%), USP compliant.

  • Applications

Detects subvisible particles in injections, infusions, sterile powders and pharmaceutical packaging materials.

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SC-4000A Clarity Tester

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  • Features

The optical system consists of tri-color fluorescent lamps, an electronic ballast and a light-shielding device, which eliminates stroboscopic flicker, enables adjustable illuminance, improves detection resolution and reduces visual fatigue.

  • Applications

Inspects clarity and visible particles in injections, infusions and bottled solutions.

PharmaAnalytica's Physicochemical Analysis Platform integrates comprehensive, high-performance and pharmacopoeia-compliant instruments, covering the full spectrum of pharmaceutical physical and chemical property testing. With robust data integrity, reliable precision and standardized workflows, the platform delivers accurate, traceable and efficient analytical results, fully supporting pharmaceutical R&D, quality control and compliance requirements, and serving as a solid technical foundation for ensuring drug safety, efficacy and quality consistency.

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