M6 QC QA

Practical / Experimental EP

endpoint that is shown by a change color of the soln being titrated

Stoichiometric/Theoretical EP

indicates that equivalent amounts of the titrant and analyte have reacted

Neutralization

depends on the # of replaceable H+/OH

Redox

depends on the amount of electrons lost or gained

Precipitation

depends on the mole ratio between the analyte and titrant

Complexation

depends on the ratio of the metal with EDTA (1:1)

Alkalimetry

neutralization reactions in titrimetric methods of analysis may be

Complexiometry / EDTA titration

metal ion binds to ligand

Precipitimetry

formation of insoluble subs to cause the reaction

Reduction-oxidation

change in valence of reacting subs

Metal ion

acts as the lewis acid

Ligand (titrant)

acts as the Lewis base

Chelate

complex formed when a molecule with >2 groups that donate electrons combine with metal ionb

Triethanolamine

masking agent for Al3+

Gravimetry

assay of NaCl in table salt by precipitation as AgCl filtration, drying and weighing the residue

Fluorometry

measure of excess energy lost by emission (B1, B2)

Turbidimetry

measures transmitted light (antibiotics, B12, Ca pantothenate)

Nephlometry

measures reflected light

Chromatography

Method used to separate and distinguishes the different substances within a mixture

Normal phase

SP is polar and MP is nonpolar

Quality assurance

sum total of the organized arrangements made with the object of ensuring that products will be consistently of the quality required by their intended

GMP

ensure that production consistently produced and controlled according to quality standards & marketing authorization

Quality Control

sum of all tests performed to determine the conformance of the product to specification; a tool for detecting variation in a process

P chart and attribute

Chart used in statistical quality control

Go or no-go and attribute

type of quality control charts based on the # of defective found

Qualification

action of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results

Specification

requirements needed to conform

Reconciliation

theoretical VS actual quantity

sampling plan

A definite working rule regarding: N (pop'n of total parts)

n (sample size)

c (amt of bad parts that will be allowable)

Inspection

comparison of attributes and dimensions of a product against a standard to find out if the product is within the limit

Manuf area,

Warehouse,

Packaging area

Inspection stations

Sampling

removing items from population in order to make interferences to the entire popl'n

Pfizer

has a plier like handles

Stokes-Monsanto

has compressible spring

Strong Cobb

with pressure operated pump

Erweka

uses suspended weight

Schleuniger

electric motor propels an anvil to press a tablet

37 +- 0.5 C

temperature used in dissolution testing

35 - 39 C

media temperature used in disintegration testing

Upward stroke

wire mesh remains at least 15mm below the surface of the fluid

Downward stroke

descends to NLT 25mm from the bottom of the vessel

Bacitracin

the antibiotics assay used for Micrococcus luteus

Streptomycin

the antibiotics assay used for K. pneumoniae

Chloramphenicol

the antibiotics assay used for E.coli

Vancomycin

the antibiotics assay used for Bacillus subtilis