multi N/C pharma from Analytik Jena

Product Details
Itemmulti N/C pharma
CompanyAnalytik Jena
PriceGet Quote
Sample Volumepharma UV: up to 20 mL (flow injection); pharma HT: up to 3 mL (flow injection); 3100 pharma: up to 1 mL (ceramic valve, flow injection); 2100S pharma: 50–500 µL (direct syringe injection)
Measuring Rangepharma UV: 1 µg/L – 10,000 mg/L C; 3100 pharma: 4 µg/L – 30,000 mg/L C; 2100S pharma: 5 µg/L – 200 mg/L TN
Detection Limitpharma UV: 1 µg/L C (ultra-trace without persulfate); pharma HT: 4 µg/L C; 3100 pharma: 4 µg/L C; 2100S pharma: 5 µg/L TN
Measurement Mode(s)TOC, NPOC, TC, TIC; optional TNb (chemiluminescence, CLD) for combustion models; multi N/C 2100S pharma: TN only for total protein determination
Oxidation Methodpharma UV: UV wet chemical digestion (254 nm + 185 nm, High Power Long Life UV reactor); pharma HT and 3100 pharma: thermocatalytic high-temperature combustion up to 950°C
ApplicationsWFI and purified water TOC monitoring; TOC cleaning validation (swab extraction and final rinse); plastic packaging leachables testing (USP 661); total protein determination in vaccines and pharmaceutical biologics; pharmaceutical quality control
Compliance / StandardsFDA 21 CFR Part 11 (multiWin software); USP 643, USP 661 (TOC); USP 1057/7.2 (total protein); EP 2.2.44 (TOC); EP 2.5.33/7B (total protein); JP XVII Total Protein Assay/7B; GxP compliance
Combustion Temperature950°C (combustion-based models: pharma HT, 3100 pharma, 2100S pharma); High Power Long Life UV reactor (pharma UV model)
SoftwaremultiWin software with FDA 21 CFR Part 11 compliance: individual e-signatures (3-stage: created/examined/authorized), audit trail, user management with configurable password complexity, SST sequence with automatic report generation, LIMS import/export, PDF/CSV export
Measurement Range0-50,000 mg/L TC
CatalystThermocatalytic (high-temperature catalyst) for combustion models
Tn DetectionOptional TNb upgrade by CLD (chemiluminescence) for pharma HT and 3100 pharma; multi N/C 2100S pharma: dedicated TN by CLD with AS 60 autosampler (protein determination per Pharm. Eur. 2.5.33/7B, USP 1057/7.2, JP XVII)
Product Modelsmulti N/C pharma UV (UV digestion, up to 20 mL injection, 1 µg/L LOD); multi N/C pharma HT (combustion 950°C, up to 3 mL injection, 4 µg/L LOD, swab module optional); multi N/C 3100 pharma (combustion 950°C, up to 1 mL ceramic valve, 4 µg/L – 30,000 mg/L); multi N/C 2100S pharma (TN/protein dedicated, 50–500 µL, 5 µg/L TN LOD)
Unique FeaturesAutomatic TIC control for complete TIC elimination in NPOC; pharma HT has Swab Test Module for direct swab combustion (quartz-fiber swabs only); auto-protection drying without desiccants; Self-Check System (SCS) for automatic parameter monitoring and tightness check; 10-year warranty on NDIR detector and furnace; 3-year warranty on UV reactor