Content uniformity assay report

Table 6.4. An Example of Content Uniformity Assay Report...

Another piece of evidence to suggest that content uniformity data is not normally distributed can also be seen in the content uniformity data of Rohrs et al.4 They report the content uniformity assay results for 11 batches of tablets. In every case except one, the actual mean potency is below the target value. If the content uniformity data were normally distributed, as assumed by the Yalkowsky and Bolton approach,2 one might expect to see a more even distribution of mean values above and below the target. The one exception was for the lowest potency batch for which one tablet was assayed to be 292% of intented value, as mentioned above. This characteristic is... 

Content Uniformity/Assay. The question most often asked is when NIR will be able to be used as a release test. In the earliest NIR assays, tablets and capsules were not analyzed intact. Prior to scanning, the active was extracted and scanned in a clear liquid. The first use of NIR for tablets was reported in 1968. Sherken assayed the meprobamate content in tablet mixtures and commercial preparations. Allen used NIR to analyze a three-component mix carisoprodol, phenacetin, and caffeine. The powder was extracted with chloroform and scanned in the NIR. Several other publications took advantage of the dissolve and scan approach.t ... 

HPLC Assay of an ethyl alcohol-acetic acid extract against a Reference Standard material (chromatographic conditions reversed-phase mode Cjo column methanol—water—acetic acid, 50 49 1 (v/v), mobile phase detection at 254 nm [79]) and (c) extraction of tablets with methanol or ethanol and UV measurements at 260 or 262 nm. Linearity in the 3—15 Ug/ml and standard errors of less than 2% were reported [65,109,110]. A similar procedure is used for the determination of the Content Uniformity of the tablets [79].. ... 

A Zymate II Pye system for automated analysis by the Zymark Corporation (USA) with on-line HPLC has been set up and used for content uniformity tests and assays, including process validation, for a variety of drug products in our QC laboratory since January 1992. The robotic system automatically performs the following operations preparation of sample and reference standard solutions, injection into HPLC, HPLC analyses, and generation of reports. 

Almost all aspects of manual analyses have been automated, ranging from sample handling to measurement with automated calculation and report generation. -96 yhgjjg automated analyses have been applied to many types of tests, including assay, content uniformity, dissolution, and moisture, and are routinely used for product release and stability testing. Some companies have constructed complete robotic laboratories in a centralized or decentralized manner to generate tens of thousands of assay results per year. 

Shinkuma et al. [14] reported a spectrophotometric assay of different commercial mefenamic acid capsules. The contents of 20 capsules of each brand were carefully removed and accurately weighed. After finding the mean weight of the capsule contents, the contents were mixed uniformly and used as the brand sample. A weighed amount of this powder, equivalent to about 150 mg of mefenamic acid, was dissolved in 200 mL... 

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