KGF-1 Polymer Impurity Analysis System

1、 Basic configuration

1. UV detector 254nm

2. Constant flow plunger pump (flow rate range 0.1-10ml/min) pressure:<2MPa

3. Manual medium low pressure six way injection valve

4. High sensitivity chromatographic signal data processing system

2、 Instrument performance parameters

Sample elution flow<10ml/min (filler: dextran gel G-10, system test: blue dextran 2000)

Analysis flow rate: 0.1-5ml/min

Detector wavelength: 254nm, high sensitivity, high performance, dual beam.

Instrument stability time: Baseline stability within 10 minutes of startup.

Light source lifespan:>20000 hours

Injection quantitative tube: 200ul optional (standard 200ul)

Specialized glass polymer chromatography column (configured according to the 10th edition pharmacopoeia)

Minimum detection limit: 1 × 10-8g/ml; (Methanol solution of naphthalene)

Baseline noise: ≤ 1.0 × 10-5AU;? （≤10uv）

Baseline drift: ≤ 1 × 10-4AU/hr;? （≤200uv）

System repeatability testing accuracy

Repeated precision of 5 injections with 0.1mg/ml blue glucose: 1. Retention time difference ≥ 0.5%, 2. Peak height: ≥ 0.5%, 3. Peak area: ≥ 0.5%

3、 Instrument features

*The use of constant current and constant pressure medium and low pressure plunger pumps greatly improves the service life and testing accuracy.

*Specialized polymer impurity trace analyzer: It has the characteristics of high sensitivity, high performance, dual beam, long light source service life, long-term use without shutting down, and strong reliability.

*The equipped chromatographic acquisition and analysis software has functions such as data reanalysis and archiving, and the data results can be operated with Excl