ABSTRACT
Objective: To evaluate the quality status of piroxicam tablets. Methods: The samples were examined by the statutory standard,and the exploratory studies were carried out. The results were statistically analyzed. Results: Totally 138 batches were exam-ined according to the statutory standard, and among them, 135 batches were qualified with the qualified rate of 97. 8% . The unquali-fied item of 3 unqualified batches was dissolution. The exploratory studies showed that there were two crystal forms of piroxicam used in the tablets, and the dissolution of the two crystal forms was different with form 1 less than form 2. An inspection method for the relative substance was established. Totally 14 impurities were detected out and the structures of 8 impurities were identified. The impurities were mainly derived from the raw materials, and many batches of samples were with single largest impurity content exceeding 0. 5% , and the total of impurity content above 1. 0% . A class I solvent 1,2-dichloroethane was detected out in 13 batches of tablets by GC and confirmed by GC-MS. Through the dissolution consistency test, it was found that there was a great difference in the dissolution behavior among the products from different manufacturers. Conclusion: The overall quality of piroxicam tablets is not ideal, and the production process of some manufacturers needs to be improved.
ABSTRACT
Objective:To evaluate the quality status of lithium carbonate tablets and lithium carbonate sustained-release tablets. Methods:The samples were examined in accordance with the statutory standard,and the exploratory studies were carried out. The results were statistically analyzed. Results:In accordance with the statutory standard,among 120 batches of samples, only one was unqualified in dissolution,and the others were qualified. The qualified rate was 99. 2% . Conclusion:The quality of the most products meets the current standard and the quality evaluation standard needs to be improved.
ABSTRACT
Objective:To examine the osmolality of domestic recombinant human interferon α2b injection to provide evidence for the improvement of the national quality standard. Methods:Totally 66 batches of recombinant human interferonα2b injection produced by 9 manufacturers were withdrawn, and the osmolality was determined according to the appendix of Chinese Pharmacopoeia Ⅲ(2010 edition). The results were analyzed with statistical methods. Results:The pass rate of osmolality was 98. 5%. The osmolality of more than 90% of the batches was between 85% and 115% of the intermediate value set by the manufacturers. Conclusion:Comprehensive understanding of the quality control of osmolality of domestic recombinant human interferon α2b injection is obtained, which provides data support for the improvement of quality standard of osmolality.
ABSTRACT
Objective: To evaluate the quality status of recombinant human interferon α2a injections and find out some quality problems. Methods:The statutory testing methods combining with the exploratory studies were used to examine the samples, and the quality status of recombinant human interferon α2a injections was evaluated by statistical analysis of the results. Results: All 28 bat-ches of the injections were qualified using the statutory testing methods. The exploratory studies showed that if the specific activity was determined, the qualified rate was only 87. 0%. All 7 batches of drug substances were qualified using the statutory testing methods. The exploratory studies showed that if the related protein was determined, the qualified rate was 57. 1%. Conclusion:At present the quality of recombinant human interferonα2a injections is generally good. The current standards are feasible;however, improvement is still needed. Specific activity determination should be supplemented the standards for drug products and related protein determination should be supplemented the standards of drug substances.