Pharmaceutical analysis documentation

In 1975 the World Health Organization produced a guideline for the establishment, maintenance and distribution of chemical reference substances (WHO 1975). This document was intended to foster collaboration and harmonization of approval for the provision of reference substances by national authorities and organizations responsible for reference substances collections. This guideline was revised in 1982 (WHO 1982) and a further revision was completed more recently (WHO 1999) to take into account progress in pharmaceutical analysis. The latest guidehne defines both primary chemical reference substance and secondary chemical reference substance as follows ... 

When the registration document (Decision of the BPR) is present there are no predictable problems with importation of registered drugs. The following documents are sufficient for customs the approval of the PC of the MOH of Ukraine and a certificate of quality from pharmaceutical company (if relevant). The check-up procedure may take up to 4-6 weeks (depending on the availability of the necessary reagents for pharmaceutical analysis). 

The response time is one of the main factors for ISME validation, because these electrodes must be used to perform dissolution tests of pharmaceuticals and potentiometrical titrations. Recovery studies are a very important means of documenting the reliability of a method. Recovery studies give information about accuracy and repeatability of the analytical method. For accurate analytical information, both the repeatability and the reliability are given by relative standard deviation (RSD) values. When ISMEs are used for pharmaceuticals analysis, the reliability must have the maximum value and RSD <1.5%. 

An analysis of self-reported interventions by hematology-oncology pharmacists and staff was also performed to document pharmaceutical care interventions over a period of approximately 8 months at the Walter Reed Army Medical Center.The interventions were analyzed to determine the types of interventions that are most frequently performed, prescribing errors encountered, medication cost avoidance that resulted from the interventions and types of interventions that are associated with medication cost interventions, and intervention acceptance rate by physicians. Interventions were entered into a personal computer and analyzed using CliniTrend Web Support System software (ASHP). Medication cost avoidance was determined if less medication was used, an equally effective but less costly medication was used, or a medication that could not be reused was not prepared. 

Chemical pretreatments may be required due to lack of selectivity and/or sensitivity of direct spectrophotometry. The chemistry of spectrophotometric determinations in pharmaceutical analysis is by now well documented common procedures are redox reactions metal ion chelation reactions for the determination of organic compound or metal ion components charge transfer complex formation reactions ion pairing and diazotization. 

DESI as with DART has found a number of applications in forensics. The lack of sample preparation and ease of surface examination makes it suited to examination for screening for explosives [203-205], forensic applications such as document ink analysis [206], latent fingerprints [207] and counterfeit pharmaceuticals [208,209],... 

Pharmaceuticals and drugs] ruggedness test, 848-864 system suitability test, 865 ralidation data elements specific to TLC, 848 mobile phase selection, 822 quality assurance of experimental data and documentation, 865-867 role of TLC in drug analysis, 868-873 chromatqgrapliic identification. 871 spectroscopic identification, 871-873 role of TLC in pharmaceutical analysis, 867-868 sensitivity to experimental conditions 821-822 stationary phase selection, 822 types of analytical aims in pharmaceutical analysis, 823... 

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