Friday, November 7, 2008

DISCUSSION ANALYSIS PHARMACEUTICAL REPORTS

Definition of validation, according to Decree No. Menkes RI. 43/MENKES/SK/1998, CPOB is about action by proving that the appropriate materials, procedures, activities, systems, equipment or mechanisms in the production and supervision always achieve the desired results (Anonymous, 2007).

Parameters that will be done in the lab validation is:
1.Akurasi
The accuracy of the results of the test parameters proximity with the actual values. There are several ways to do this parameter, among others, by calculating the value of recovery. Criteria keberterimaannya is RSD <1%.> 0.98. Linearitas expressed in terms of variation sekitas slope and the regression line, which is calculated according to the results of the relationship mathematic obtained from analisi with analit rate varies.

In the groups we use the method spektrofotometer UV and compound drugs, which is defined here Izoniazid (DOT). Izoniazid can be determined with this method because it has a cluster Izoniazid absorptive chromophores, that is not saturated kovalen clusters that can absorb radiation in the UV-Vis region. (Anonymous, 2007).
Structure Izoniazid (DOT)

C - NH - NH2

E1 cm

N
The nature-general
Isoniazid is the chemical name 4 - Piridin - Karboksilat hidrozid compound is a hidrozid from acid isoni katinat.
Isoniazid has the empirical formula with a molecular weight C6H7N3O BM: 14

Slowly influenced by air and light. Easily soluble in water, slightly soluble in ethanol difficult, difficult soluble in ethanol, soluble in difficult Chloroform and ether.

-Benefits
Isoniazid until now still used as medicine in the treatment of all types tuberkolosis mainly in the form of combination. As profilaktik can digunaka in the form of single. Bakterisid as Isoniazid can be used to treat infections, bacterial infection intraseluler and ekstraseluler trutama mikrobakteri requiring biosenteris acid mikolat in the cell wall.
Isoniazid is a derivat acid isoniazid have tuberkolusis most of the strong results that are growing rapidly. Intraseluler active against bacteria in mikrolag and in the uar cells (esktraseluler).
The first step is done to make the stock. With the weighing 0.1 g DOT are dissolved in pure water and then entered in the pumpkin peck ad aquadest 100 ml. Operating Time is not done because the DOT is a stable solution (time serapannya stable). Time Operatig determination of the compound only to establish the complex color. After a mixed solution, then it must be filtered before the absorbansinya read, because there is the possibility of yag difficult once soluble, so look cloudy. In order not to disrupt the reading in spektrofotometer UV filter to the need to be clear.
) from thelThe second step is determining the long-wave ( maximum laruta stock. Wavelength one laruta provide serapan the largest. Serapan measurement using the maximum length of the wave will cause the maximum serapan also. In the long-wave maximum absortivitas molar relatively stable and showed linear calibration curve. Taking stock solution of 1 ml kmudian be aquadest with 10.0 ml. Then read on the wave length 250-300 nm wave. Because the known 226 nm is the wavelength, the DOT aquadest. Serapan obtained from the trial's most high on the wave length

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