Metrohm 726 Titroprocessor User Manual

Page 286

13.5 Validation / GLP

726 Titroprocessor, Instructions for use

280

ЪДДД Validation Method Definition ДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДД¿

³ ³

³ Method HCl .mth ³

³ Comment Validation method ³

³ Storage Internal ³

³ ³

³ Limits ³

³ ДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДД ³

³ Mean value 0.990 1.010 ³

³ Standard deviation absolute ñ 0.005 ³

³ relative ñ 0.5 % ³

³ Systematic deviation d(rel) ñ 1.0 % ³

³ Systematic error (intercept) ñ 0.050 mL ³

³ ³

³ Validation interval 12 month(s) ³

³ ³

АДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДДД QUIT ÄÙ

Select a memory area (internal memory or data card) and a stored method.

In order to open a selection list use the space bar or the [Cancel] soft-
key. Enter a comment and set the limits for the validation results.

Limiting values and their meaning

The validation results represent and provide a reliable assessment of the

accuracy and reproducibility of your titration system, including dosing de-

vices and sample changer.

Mean value

The mean value of all determination results (RT1) of the
validation series. At least 10 determinations should be

carried out. We recommend titer determinations as vali-

dation methods.

Standard limiting value 0.990…1.010

Standard deviation absolute

Absolute standard deviation of the results (RT1) of the

validation series.

Standard limiting value ± 0.005 (for titer determinations)

Standard deviation relative

Relative standard deviation in percent.

Standard limiting value ± 0.5%

Systematic deviation d(rel)

Systematic deviation of mean value against theoretical

result (RT2).

rel

−

result

* 100

mean

theo

Standard limiting value ± 1.0%

Systematic error (a

sys

)

Systematic error, caused by interfering influences such

as solvent blank values or method-related problems. It

is determined by the axis intercept of the linear regres-