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摘要：Quality control is one of a number of concerted measures that analytical chemists can take to ensure that the data produced in the laboratory are fit for their intended purpose.

quality control of sampling is a separate subject and in many areas is not fully developed. Moreover, in many instances analytical laboratories have no control over sampling practice and quality.

2.In-line analysis and continuous monitoring. In this style of analysis there is no possibly of repeating the measurement, so the concept of IQC as used in this document is inapplicable.

3.Multivariate IQC. Multivariate methods in IQC are still the subject of research and cannot be regarded as sufficiently established for inclusion here. The current document regards multianalyte data as requiring a series of univariate QC tests. Caution is necessary in the interpretation of this type of data to avoid inappropriately frequent rejection of data.

4.Statutory and contractual requirements.

5.Quality assurance measures such as checks on instrumental stability before and during analysis, wavelength calibration, balance calibration, tests on resolution of chromatography columns, and problem diagnostics are not included. For present purposes they are regarded as part of the analytical protocol, and QC tests their effectiveness together with the other aspects of the methodology.
Bi-Profenid

Ketoprofen150 mg

Ketoprofen

Analgesic

3-Benzoyl-α-methylbenzeneacetic acid

C16H14O3=254.3

A white crystalline powder. M.p. 93° to 96°.

Slightly soluble in water, soluble in acetone, ethyl acetate, ethanol ,chloroform and ether.

Dissociation Constant:-PKa4.5.

Partition Coefficient:-LogP(octanol/buffer pH 7.4), 0.

Colour Tests.

Aromaticity (Method 2)—colourless/yellow; Koppanyi-Zwikker Test—violet.

Thin-layer Chromatography.

System TD—Rf 27; system TE—Rf 06; system TF—Rf 25; system TG—Rf 14; system TAD—Rf 41; system TAE—Rf 85; system TAJ—Rf 54; system TAK—Rf 82; system TAL—Rf 98. (Ludy Tenger reagent, orange.)

Gas Chromatography.

System GA—ketoprofen RI 2245; ketoprofen-Me RI 2090; system GD—Retention time of methyl derivative 1.45 relative to n-C16H34; system GL—ketoprofen-Me RI 2090; M(OH-)-Me2 RI 2250.

High Performance Liquid Chromatography.

System HAA—Retention time(s) 19.6min; system HD—k 2.4; system HV—Retention time 0.66 relative to meclofenamic acid; system HX—RI 495; system HZ—Retention time(s) 6.4min.

Ultraviolet Spectrum.

Aqueous acid—260 (A11=665a); aqueous alkali—262nm (A11=647a).

Infra-red Spectrum.

Principal peaks at wavenumbers 1656, 1693, 1284, 714, 690, 1226cm−1 (KBr disk). Two polymorphic forms may occur.

, 210, 103, 181.

Quantification

Gas chromatography

In plasma: limit of detection 130μg/L, ECD—P.

Gas chromatography-mass spectrometry.

In plasma or synovial fluid: ketoprofen and ibuprofen, limit of detection for ketoprofen <2μg/L.

Disposition in the Body

Ketoprofen is readily absorbed after oral, rectal, or IM administration. About 75% of a single oral dose is excreted in the urine in 24h, mostly in the first 6h, about 90% of which is the glucuronide conjugate; hydroxylation may also occur.

Therapeutic concentration

After oral administration of 100mg as capsules, to 7 subjects, peak plasma concentrations of 6.0 to 14.3 (mean 10)mg/L were attained in 0.45 to 2.5h; a single rectal dose of 100mg produced peak 本论文由英语论文网提供整理，提供论文代写，英语论文代写，代写论文，代写英语论文，代写留学生论文，代写英文论文，留学生论文代写相关核心关键词搜索。