Quantitative Pharmaceutical Chemistry Flashcards
Application of the procedures of quantitative analytical chemistry
1. Analysis and determination of the purity and quality of drugs and chemicals
2. Analysis of the chemical constituents found in the human body
3. Analysis of medicinal agents and their metabolites
Quantitative Pharmaceutical Chemistry
The sum of all factors which contributes directly or indirectly to the safety, effectiveness and reliability of the product.
Uniformity, consistency and conformity to standards.
Characteristics that must be built into the product during product and process design
Quality
Begins in research and development (pre-formulation
Physical, chemical and therapeutic considerations,
Considers materials, in-process and product contro
influenced by physical plant design, space, ventilation, cleanliness and sanitation during routine production.
Quality Control
The overall organization body designed to assure product quality.
The sum of all tests performed to determine the conformance of the product to specifications.
Quality Assurance
It is a legally binding collection of standards and quality specifications for medicines used in a country or a region.
It has a set of appropriate tests that will confirm the identity and purity of the product.
olt covers pharmaceutical starting materials, excipients, intermediates and finished pharmaceutical products.
Pharmacopeia
A document containing the result of all the tests conducted on a specific material or product to show compliance or non- compliance with established standards or specifications approved by responsible personnel.
Certificate of analysis
Assess unequivocally the analyte in the presence of component that may be expected to be present.
Specificity
Measure of capacity to be unaffected by small but deliberate variations in method & provides indication of its reliability during normal usage.
Robustness
