Quality control

How To Know About Pharmaceutical Analysis in Quality Control

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Pharmaceutical Analysis

Pharmaceutical Analysis may be defined as the application of analytical procedures used to determine the purity, safety, and quality of drugs and chemicals.

This pharmaceutical analysis has access to the full range of

  • Titration method
  • Spectroscopic technique
  • Chromatographic method

Titration method:

  • Aqueous acid-base titration: An aqueous acid-base titration is the determination of the concentration of an acid or base by exactly neutralizing the acid or base with an acid or base of known concentration.


  • Non-aqueous acid-base titration: Non-aqueous titration is the titration of substances dissolved in solvents other than water. It provides a solvent in which organic compounds are soluble.


  • Redox titration: A redox titration is a type of titration based on a redox reaction between the analyte and titrant.


  • Complexometric titration: a complexometric titration is a form of volumetric analysis in which the formation of a colored complex is used to indicate the endpoint of a titration.


  • Potentiometric titration: Potentiometric titration is a technique similar to direct titration of a redox reaction. It is a useful means of characterizing an acid.


  • Amperometric titration: Refers to a class of titrations in which the equivalence point is determined through measurement of the electric current produced by the titration reaction.


  • Aquametry: Aquametry in analytical chemistry refers to analytical processes to measure the water present in materials.


  • Refractometry: Refractometry is the method of measuring substances refractive index one of their fundamental physical properties in order to assess their composition or purity.


  • Polarimetry: Polarimetry is a sensitive non-destructive technique for measuring the optical activity exhibited by inorganic and organic compounds.


  • Nephelometry:


Nephelometry is a technique used in immunology to determine the levels of several blood plasma proteins.

Spectroscopy Method:

            Spectroscopy is the science which deals with the interaction between a matter and an electromagnetic radiation.

Ultra Violet and Visible spectroscopy: It is a type of absorption spectroscopy that uses the ultraviolet and visible parts of the electromagnetic spectrum.


Nuclear magnetic resonance spectroscopy:

NMR is a physical phenomenon in which nuclei in a magnetic field absorb and re-emit electromagnetic radiation. This energy is at a specific resonance frequency which depends on the strength of the magnetic field and the magnetic properties of the isotope of the atoms, in practical applications, the frequency is around (60-1000 MHz).


Mass Spectroscopy:

In this spectroscopy, sample molecule is bombarded with an energetic beam of electrons. Molecules are then ionized and fragmented. Each kind of ion has a particular ratio of mass to charge. For most ions, the charge is one and thus m/e ratio is simply the molecular mass of the ion.

Atomic Absorption Spectroscopy:

AAS is a spectro analytical procedure for the quantitative determination of chemical elements using the absorption of optical radiation by free atoms in the gaseous state.

Chromatographic Method:

          Chromatography: Chromatography is usually a technique for separating and identifying the components in a mixture. It is a powerful method in the industry.

Some Important types of chromatography in pharma industry:


  • Paper chromatography
  • Gas chromatography
  • Liquid chromatography
  • High-performance liquid chromatography
  • Gel filtration chromatography


Important of Pharmaceutical Analysis

  • The identity of the drug in the formulated product.
  • Determination of active ingredient or additional impurities.
  • Stability of the drug.
  • The rate of the drug from its formulation.
  • Identity and purity of pure drug that meets specification.
  • Concentrations of specified impurities.
  • Concentrations of drug in plasma or biological fluids.
  • Determine pka values, partition coefficients, solubilities and stability of drug under development.


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