Labels strength

Name (give labeled strength A mlr/la baler, if known) 1... 

According to the FDA guidances, if the drug is sufficiently highly soluble and permeable, and dissolution of the drug from the reference and test products occurs to an extent of 85% of label strength or better within 30 min in three media (pH 1.2, 4.5, and 6.8 are currently recommended), this is viewed as adequate proof of bioequivalence, provided the... 

Amgen, in May 2001, was forced to recall its Epogen when counterfeit vials of the product were discovered in the market. Investigation revealed that the counterfeit drug contained only one-twentieth of the labeled strength. 

Name (give labeled strength mtr/labeler, If known)... 

From 1982 through 1985, few NIR analyses of dosage forms were published. Since 1986, there have been many articles. The first was a 1986 paper by Ciurczak and Maldacker [33] using NIR for tablet formulation blends, examining the use of spectral subtraction, spectral reconstruction, and discriminant analysis. Blends were prepared where actives—aspirin (ASA), butalbital (BUT), and caffeine (CAF)—were omitted from the formulation or varied over a range from 90 to 110% of label strength. 

The third experiment classified samples by discriminant analysis. In one series of blends, the CAF, BUT, and ASA concentrations varied independently between 90 and 110% of labeled claim. In another series, one of the three drugs was excluded from the mixture, while the others were varied between 90 and 110%. The Mahalanobis distance statistic was used for classification of formulations. This technique was used for samples of complete formulations (all three drugs at 100% of label strength), borderline formulations, and samples lacking one active component. 

These researchers also compared the performance of NIR with the UV reference method in the determination of cimetidine content. Samples of 100% label strength were prepared and analyzed by both methods. The standard errors for the NIR (2.73%) and the UV (2.97%) assays were virtually identical. 

HPLC was used as the reference method and the tablets were found to vary between 96 and 102% of labeled strength. To determine the accuracy and precision of the method, one tablet was analyzed ten times with sample removal and replacement between scans. The NIR-determined value was within 0.5 mg of the HPLC-determined value, indicating the accuracy of the method. Tablet placement on the spectrometer played an important role in the precision of the method, even with the use of the aperture plate. 

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