E.coli Host Cell DNA Residue Detection Kit (2G) _ 41308ES

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E.coli Host Cell DNA Residue Detection Kit is used for the quantitative analysis of E.coli host cell DNA residuce in intermediate samples, semi-finished and finished products of va rious biological products. This kit adopts Taqman fluorescent probe and the polymerase chain reaction (PCR) method, which has fg level minimum detection limit and can specifically and quickly detect the residual E.coli cell DNA. The kit needs to be used together with the the Residual DNA Sample Preparation Kit (Cat# 18461ES). Validation Report Features High Interference Resistance: For complex matrices, sample spike recovery rates reach at least 70%–130%. High Sensitivity: Lower limit of quantitation (LLOQ) is 30 fg/μL. High Precision: High intra-assay repeatability (CV < 10%) and low inter-assay variation (intermediate precision CV < 15%). High Specificity: Specifically detects residual E. coli DNA without interference from other exogenous genomic DNA. Comprehensive Validation: Validated according to ICH Q2 (R2) guidelines for analytical procedure validation, with comprehensive validation reports available. Regulatory Compliance: Validated in compliance with EP 2.6.7, JP G3, and USP pharmacopeia requirements, meeting international regulatory standards. Guaranteed Quality: All enzyme raw materials required for the kit are produced in-house at an industrial scale, ensuring stable supply. Specifications Cat.No. 41308ES50-EN / 41308ES60-EN Size 50 T-EN / 100 T-EN Components Components No. Name 41308ES50-EN 41308ES60-EN 41308-A E.coli qPCR Mix 0.75 mL 1.5 mL 41308-B E.coli Primer&Probe Mix 250 μL 500 μL 41308-C DNA Dilution Buffer 2×1.8 mL 4×1.8 mL 41308-D E.coli DNA Control（30 ng/μL） 25 μL 50 μL Storage This product should be stored at -25~-15℃ for 2 years. Both 41308-A and 41308-B should be stored protected from light. Applicable instrument models Include but not limited to: Bio-Rad: CFX96 Optic Module. Thermo Scientific: ABI 7500; ABI Quant Studio 5. Instructions Figures 1.Good linearity: Linear range from 30 fg/μL ~ 300 pg/μL, R²= 1.000, Eff=101.74%, CV Show more