Pharma Analysis 1 Flashcards
total amount of a class or a group of active plant principles in a given sample
Proximate analysis
Amount of a specific constituent
or a single chemical specified
present in the sample.
Ultimate analysis
Other names for Classical Method
General/ Chemical/ Wet/ Stoichiometric
VOLUME of standard solution reacting with
the analyte
Titrimetric→ Volumetric Analysis
WEIGHT of pure analyte or compound of known stoichiometry
Gravimetric Analysis
Based on a specific PHYSICAL or
CHEMICAL PROPERTIES of the
analyte
Instrumental method
More accurate analysis
Instrumental method
Method for (Light Absorbed/
Transmitted)
Spectrophotometry
Method for (Optical Activity)
Polarimetry
Method for (Separation, Identification,
Determination)
Chromatography
involves crude drugs (collection
and drying)
Miscellaneous or
Special method
transferring of a proton from one
molecule to another
Protolysis
gives up a proton per molecule
or ion
Monoprotic Acids
can accept one proton
Monoprotic Bases-
transferring of a proton from one
molecule to another IDENTICAL MOLECULE
Autoprotolysis
Property where a substance can act
either as acid or base
Amphotheric
Ability of a buffer solution to resist
changes in pH upon addition of
acid/alkali
Buffer Capacity
Amount in g/L of strong base
required to be added to a
solution to change its pH by 1
unit
Van Slyke
Higher buffer capacity, the ___ change in pH
lower
change in pH
number of moles of solute per liter of
solution
MOLARITY
the number of moles of solute
present per kg of solvent
MOLALITY
the gram equivalent weight per liter
of solution.
NORMALITY
Determination of volume (mL/ liter) of soln.of known concentration
required to react with a given amount of substance to be analyzed.
VOLUMETRIC ANALYSIS
A K A TITRATION
Sample of substance being analyzed
Active constituent to be analyzed
ANALYTE
Aka Titrand
Volumetric or standard solution of known concentration
TITRANT
Aka Standard
Solution
chemical capable of changing color at or very near endpoint
INDICATOR
shown by the changes of color
→ Practical point / OBSERVABLE
ENDPOINT
Theoretical point at which Equivalent amt.of substance have
reacted
EQUIVALENCE/
STOICHIOMETRIC
POINT
grams of substance that is chemically equivalent to 1 mL of a
volumetric solution.
TITER
is a solution of known concentration or a solution
whose exact concentration is known.
Standard Solutions
process of determining the exact concentration of a
solution.
Standardization
Substance of
known conc. and
high degree of
purity (99.9%)
Primary std.
Solid
Std. Solution of known conc.
Usually standardized by primary std.
Lower degree of purity
Secondary std.
Liquid
Type of Titration
Only 1 volumetric solution/standard solution
Direct
Type of Titration
Uses 2 volumetric solution
Residual/Back
Titration
Types of Titration
Preliminary preparation/ treatment of the sample before introducing the titrant in the analyte
Indirect
Types of Titration
Perform the entire titration procedure without the
ANALYTE
To correct errors
Blank
determination
Burettes used in titration:
MOHR/ base
Rubber tube + pinchcock
Burettes used in titration:
GEISSLER/ acid
Glass Stopper
NEUTRALIZATION
TITRANT + ANALYTE =
SALT AND WATER
A method designed to determine and
quantify ammonia in ammonium sulfate obtained by
decomposing organic substance with sulfuric acid
Kjeldahl Method
To determine composition of certain mixtures (alkaline)
Double Indicator
Titration
Analyte is titrated with a standard solution of a
precipitating agent in the presence of suitable
indicator.
PRECIPITATION METHOD
The process based on the formation of a complex substance in the
course of analysis.
COMPLEXATION METHOD
Molecules which provide a group of attachment to
metal ion
Ligand
bind to a metal ion through only one atom
Monodentate
ligand
more than 1 group that binds the metal ion
Multidentate
ligand
Measure of the strength of the interaction
between the reagents that come together to form
the complex.
Stability Constant
release the metal ion from the masking
agent
Demasking agents
Transfer of electrons from one species
of the reactant to another.
REDUCTION-OXIDATION METOD
is the number having the positive,
negative or zero value that may be assigned to an
atom of that element in a compound
▪Oxidation number
Assays of the SULFA DRUGS and other compounds
containing an ARYLAMINO group
DIAZOTIZATION
Analysis wherein the constituents of a sample are separated and the product is weighed.
GRAVIMETRIC METHODS
-Determination of ash content: igniting the sx in to dull redness
-Residue should not exceed 500microgram
RESIDUE ON
IGNITION
RESIDUE ON
IGNITION
LOSS ON
IGNITION
amount of volatile matter that is driven off at 110-
120deg.c
LOSS ON
DRYING
800±25c
2 consecutive weighings do not differ by more than
0.5mg/g
Additional 15 min. Ignition period
IGNITE TO
CONSTANT
WEIGHT
110-120c
2 consecutive weighings do not differ by more than
0.5mg/g
Additional hour. Ignition period
DRYING TO
CONSTANT
WEIGHT
- Residue remaining after incineration
- represents inorganic salts
- Serve as a basis for judging the identity and cleanliness of a drug
ASH CONTENT DETERMINATION
No treatment
Carbonates, phosphates, sulfates, cl, oxides,
mg
TOTAL ASH
Represents silica
Part of total ash not soluble in dilute (3N) HCl
(determines silicates)
ACID INSOLUBLE
ASH
Represents sol. chlorides, alkali and NH4
salts
WATER SOLUBLE
ASH
WATER SOLUBLE
ASH
SULFURATED ASH
WATER CONTENT DETERMINATION
=for crystalline cpds
that contain water of
hydration or absorbed
water
Method I
WATER CONTENT DETERMINATION
=most rapid, requires
only a small sx and is
specific for water
Method I
WATER CONTENT DETERMINATION
=specified for the
determination of
moisture content of
many veg drugs
containing 2% or more
of moisture.
Method II
WATER CONTENT DETERMINATION
=when drug contains
matter other than water
which is volatile at
105C, the volatile ether
soluble extractive must
be determined
Method III
=for determining water at very low
concn
DEW POINT METHOD
=for determining extremely low concn
of water
ELECTROLYTIC HYGROMETIC METHOD
value or number of physical and chemical properties.
Constant
compounds consisting of fatty acids combined with glycerol via ester linkages.
FATS
contain relatively high quantities of liquid glycerides (glyceryl oleate).
FIXED OILS
are esters of high molecular weight monohydric
alcohols and high molecular weight fatty acids.
WAXES
are substances containing benzoic or cinnamic acids.
BALSAMS
are natural or induced solid or semi-solid exudates
from plants characterized by being insoluble in water,
soluble in alcohol and ether, crystallizable and
softening or melting at a moderate heat.
RESINS
Neutralize the free acids in 1g
ACID VALUE
Neutralize the free acids in 1g
ESTER VALUE
of KOH equivalent to OH content of 1 g subs
Hydroxyl Value
Neutralize free fatty acids and saponify esters
Saponification
Value/ Koettsdorfer Value
Neutralize acetic acid obtained by the
saponification of 1g of acetylated fatty
acids
ACETYL VALUE
of mg of Iodine absorbed by 100 g
substance
Measures degree of unsaturation
IODINE VALUE
for the analysis of beeswax for adulterants (parafin)
* for the analysis of waxes for adulterants (rosin, stearic
acid)
Ester Value
gives an indication of the identity and purity of fatty
substances possessing alcoholic hydroxyl groups
Hydroxyl Value
for the detection of glycerides of fatty acids w/c
contains < 16 or >18 C atoms
Saponification Value/
Koettsdorfer Value
this is impt as this indicates whether they are pure or a
mixture, for detecting adulteration
* indicate the class of an unknown fat/oil
Iodine Value
corresponds closely to the OH value of fatty alcohol
and the two constants
Acetyl Value
Present in oils/fats that are not saponified by alakali oh
but soluble in ordinary fat solvents
Unsaponifiable Matter
unsaponifiable petroleum oil
(Vegetable Origin)
Phytosterol
unsaponifiable petroleum oil
(Animal Origin)
Cholesterol
The number, in mEq of oxygen, of peroxides in 1g of
sample
Peroxide Value
Defined as 100x the absorbance (at 350nm) of a
solution resulting from reaction of 1g of fat in 100mL of
solvent
Anisidine Value
Combined PV and Ansidine Value (2PV + AV)
Total Oxidation Value
Congealing point
Solidification
Temperature of FA
Measure of gas liberated or removed under the
conditions described by the assay
Gasometric assay
Instrument for Gasometric assay
Nitrometer
Measures optical activity (levo and dextro)
Polarization
bending of light passing from one
medium to another
Refraction
ratio of velocity of light in air to
velocity of light in medium
Index of refraction
Bisulfite method - uses what flask
Cassia Flask
The ______ is provided with a long neck
calibrated into eight divisions of 0.2 mL each.
Babcock Bottle
They are generally complex products composed of mixtures of compounds of widely variant chemical characteristics.
VOLATILE OILS (Ethereal Oils or Essential Oils or Essences)
determined by the Westphal balance or pycnometer.
Specific gravity
measured by a polarimeter.
Rotatory power
most commonly used instrument is the Abbe Refractometer.
Refractive index
provides the official method for determining the distilling range.
Distilling range
determines possible presence of alcohol which
distills or boils below 100°C.
Fractional
distillation
Product of extraction procedure
EXTRACTIVES
generally used for
extraction with volatile
solvents where small
quantities of a drug are
extracted.
Soxhlet apparatus
Solvent used for resinous matter is
ALCOHOL
The combination of attributes or characteristics of a product which ,
when compared to a standard, serves as a basis for measuring the
degree of acceptability
Quality
Measure to prevent or eliminate drugs’ risks
Control
A tool that gives the assurance that a product conforms to standards
Quality Control
The sum of total organizes activities performed with the intent to
ensure that all active pharmaceutical ingredients are of quality
Quality
Assurance
This system is a combination of those administrative and technical
procedures, which must be used to produce safe, effective, quality
products
Quality Control
System
Process inside the org that aims to improve the performance by
learning about good practices through looking at other organizations
Benchmarking
A mngt approach, centered on quality, based on the participation of
all its members and aiming at long-term success
Total Quality
Management
Quality assessment with an attached judgement that the evaluated
unit is good enough to exist. This is repeated in a cyclical process.
Accreditation
A UN agency that promoted devt of standardization and related activities to facilitate intl trades in goods and services
ISO
An undesirable characteristic of a product
DEFECTS
Unit of a product which contains one or more defects
Defective
The method of withdrawing unsafe health products
Product Recall
Sources of Quality
Variation (4Ms)
Materials, Machines, Methods, Men
Measure of the central tendency
Mean
Most common occurring value
MODE
Difference between the largest value and
smallest value
Range
Measures the amt of data dispersion around the mean
SD
Measures the diff of actual values with the mean value
AD
