Pharmaceutical analysis involves analytical procedures to determine the purity, safety, quantity, and quality of drugs and chemicals. It is important for identifying the drug substance and any impurities, determining active ingredient concentrations and specified impurity levels, and ensuring stability of the drug over time. Quantitative analysis measures concentration or quantity, while qualitative analysis identifies substances and impurities. Accuracy refers to closeness to the true value, and precision refers to repeatability of results between measurements. Primary standards are pure reagents used to determine concentrations of secondary standards, which are prepared in the lab.

2. • PHARMACEUTICAL ANALYSIS may be defined as the
application of analytical procedures used to determine the purity,
safety, quantity and quality of drugs and chemicals.
Importance of Pharmaceutical Analysis
• Identity of the drug in the formulated product.
• Determination of active ingredient or additional impurities &
concentrations of specified impurities.
• Stability of the drug.
• Rate of drug release, pka values, partition coefficients , solubilitiy,
and stability of drug from its formulation.
• identity and purity of pure drug that meet specification.

3.  QUALITATIVE ANALYSIS-
To identify drug substance, impurities etc
 QUANTITATIVE ANALYSIS
To determine the conc. Or, to measure the quantity.
 ACCURACY-
Closer to the true value or standard value.
E.g,- in a titration the standard reading for a drug is 10.
after performing the expt. these 3 values are obtained i.e,
9.9,9.8,9.7.
Qus- what is the accuracy here?

4.  PRECISION-
Repeatability of the result or, closeness between a set of condition.
E.G- In a titration after performing the expt. The 3 set of reading are,
1. 9.2, 9.5, 9.9
2. 9.2,9.4,9.6
3. 9.3,9.4,9.5
Qus. What is the precision reading here?
 ERROR- Refers to the difference in the standard values and the true
value/ mistake in expt.
Errors that may be broadly divided into two heads namely :
(i) Absolute error
(ii) Relative / % error

5. (i) Absolute error = standard value- observation value
(ii) Relative / % error = (standard value- observation value /
standard value) x 100
RELATIVE / % ERROR
1. determinate/ systemic- easily determined and rectified.
2. Random/indeterminate/in-systemic – can’t detected and do
not rectified.

6.  Primary Standards (always pure)
A primary standard is a reagent having the known concentration and
used to determine the concentration of the different analyte.
(secondary)
 Secondarystandard
• is a standard that is prepared in the laboratory for a specific
compound or element analysis.
Properties-
• standardized against a primary standard.
• Unknown concentration.
• Not pure

10. METHODS TO EXPRESS CONCENTRATION-
1. Normality(N)= ?
2. Molarity(M)=?
3. Molality(m)=?
4. PPM= (Mass of solute/mass of sample) x 1006
5. % mass=
(Mass of solute/mass of solution) x 100
6. Mole %= mole fraction x 100
7. w/w, v/w, v/v, w/v

11. THEORIES OF ACID- BASE-
1. Arrhenius concept
2. Lewis concept
3. Bronsted- lowery
4. Usanovich concept (combination of above 3)
5. lux- flood
Acid- accept oxide ion.