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GC USP-Methods
Permitted deviations without validation
| Parameters | Permitted deviation* |
| Column length | +/- 70 % |
| Packing material | Any (as long as SST criteria are met and the column or support category (GXX or SXX) remains the same ("remaining same chemistry") |
| Injection and split volume | The injection and split volume can be adjusted if detection and repeatability are satisfactory. |
| Oven temperature | +/- 10 °C |
| Oven temperature programme | The temperatures may be adjusted as specified above. If the specified temperature must be maintained or if the temperature must be changed from one value to another, an adjustment of up to ±20% is permitted. |
| Flow rate | +/- 50% (Note - If the monograph specifies a linear velocity parameter, the allowable flow rate adjustment is between +50% and -25%, provided the carrier gas system can be kept under control at the desired setpoints). |
| Particle size | Changing particle sizes of a GC mesh support is allowed as long as the chromatography fulfils the system suitability requirements and the same particle size range ratio is maintained. The particle size ratio is defined as the diameter of the largest particle divided by the diameter of the smallest particle. |
* Modifications outside the specified limits are considered "changes" that require revalidation of the method used