Search results
Results from the WOW.Com Content Network
An analytical balance (or chemical balance) is a class of balance designed to measure small mass in the sub-milligram range. The measuring pan of an analytical balance (0.1 mg resolution or better) is inside a transparent enclosure with doors so that dust does not collect and so any air currents in the room do not affect the balance's operation.
[3] [4] The most common approach for accounting for matrix effects is to build a calibration curve using standard samples with known analyte concentration and which try to approximate the matrix of the sample as much as possible. [2] This is especially important for solid samples where there is a strong matrix influence. [5]
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
Validation of analytical procedures is imperative in demonstrating that a drug substance is suitable for a particular purpose. [5] Common validation characteristics include: accuracy, precision (repeatability and intermediate precision), specificity, detection limit, quantitation limit, linearity, range, and robustness.
In United States Pharmacopeia (USP) General Chapter <711> Dissolution, there are four dissolution apparatuses standardized and specified. [6] They are: USP Dissolution Apparatus 1 – Basket (37 °C ± 0.5 °C ) USP Dissolution Apparatus 2 – Paddle (37 °C ± 0.5 °C) USP Dissolution Apparatus 3 – Reciprocating Cylinder (37 °C ± 0.5 °C)
The calibration curve that does not use the internal standard method ignores the uncertainty between measurements. The coefficient of determination (R 2) for this plot is 0.9985. In the calibration curve that uses the internal standard, the y-axis is the ratio of the nickel signal to the yttrium signal.
The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF. [2] If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF".
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.