GMP API Product Tolperisone Hydrochloride CAS 3644-61-9 Tolperisone HCL

Tolperisone Hydrochloride

Tolperisone Hydrochloride, The precision is evaluated by the closeness of multiple assay results of Tolpropofol Hydrochloride samples under the assay conditions. Precision is tested at two levels, i.e., repeatability and intermediate precision. For repeatability, prepare 6 Tolpropofol Hydrochloride sample solutions under the assay conditions to assay Tolpropofol Hydrochloride, with the 6 assay results as the repeatability; for intermediate precision, assay 6 replicates by different analysts at different times and under other variable factors, with the assay results as the intermediate precision.

(1) Repeatability

Under the assay conditions, take Tolpropofol Hydrochloride samples, prepare 6 replicates by the analyst (I), and assay with the electrode (9145150) on the potentiometer (ZDJ-400DS) on August 16, 2022.

Solution Preparation:

Sample: Accurately weigh 0.2500 g, 0.2505 g, 0.2498 g, 0.2498 g, 0.2498 g and 0.2497 g of Tolpropofol Hydrochloride sample and transfer into a 100 ml titration vessel, and add 35.0 ml of diluent (mixture of acetic anhydride and glacial acetic acid).

Repeatability Test Results:

1) The maximum content obtained from 6 repeated injections was 100.41%, the minimum content was 100.15%, and the mean content was 100.27%. The repeatability test results met the acceptance criteria;

2) RSD of contents tested from 6 repeated injections = 0.096%;

3) 90% two-sided CI of results obtained from 6 repeated injections: μ = 100.27% ± 0.07942%.

(2) Intermediate Precision

Analyst-1 performed intermediate precision-1 test on Day-2 using a potentiometric titrator (ZDJ-400DS).

Sample: Accurately weigh 0.2496 g, 0.2497 g, 0.2500 g, 0.2500 g, 0.2498 g and 0.2499 g of Tolpropofol Hydrochloride sample and transfer into a 100 ml titration vessel, and add 35.0 ml of diluent (mixture of acetic anhydride and glacial acetic acid).