Method Validation
Residual Solvents test method validation
Instrument:Agileng 6890N(TCD,FID)
Design and Development Qualification: Agilent
Installation Qualification: Agilent
Operational Qualification: Agilent
Performance Qualification:Agilent
Validation Items: System Suitability, Precision (Repeatability, Intermediate Precision), Specificity,
Linearity, Accuracy, Quantitation Limit and Detection Limit, Range
System suitability: Resolution (R) ≥2.0
RSD ≤3.9891*(%of analyte)-0.1502
Precision: Repeatability RT RSD ≤3.9891*(%of analyte)-0.1502
Peak area RSD ≤3.9891*(%of analyte)-0.1502
Intermediate precision: By different persons in the same day
RSD ≤3.9891*(%of analyte)-0.1502
By the same person in the different days
RSD ≤3.9891*(%of analyte)-0.1502
Specificity:
R. ≥2.0
Recovery between 90%-110%
Linearity:
The linearity range is from 50% of residual solvent limit to 200% of the limit.
For each solvent R ≥ 0.995
LOD:
Signal / Noise ≥ 3
LOQ:
Signal / Noise ≥ 10
Accuracy:
Recovery was between 90% and 110%
Other method validation services
Method validation for Quality impurities, Quantity impurities, Assay, water, specificrotation, identification
A lot of methods or equipments could be involved such as: HPLC, GC, UV, Polarmeter, KF water, titration and so on. |