Pharmaceutical Analysis: Definition and Scope : Pharmaguideline

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Pharmaceutical Analysis: Definition and Scope

The purpose of Pharmaceutical Analysis is to identify substances, purify them, separate them, quantify them, determine the molecular structures.


The purpose of Pharmaceutical Analysis is to identify substances, purify them, separate them, quantify them, determine the molecular structures of chemical compounds that make up pharmaceuticals, and determine how these compounds are combined to make up a pharmaceutical product.

Specifically, it relates to the analysis of raw materials and pharmaceutical formulations, entails the determination of ingredients, impurities, excipients, and uniformity, solubility, and dissolution rate to identify active components, contaminants, and impurities.

Depending on the dosage form and the compound, the sample may be singular or combination. The substance utilized for pharmaceutical purposes is animals, plants, microbes, minerals, and a wide variety of synthetic chemicals. This study focuses mainly on assessing the quantities and quality of drugs and their impurities in the development process. In the discipline of pharmaceutical development, this domain addresses needs related to drug safety, manufacturing efficiency, lowering development expenses, and providing market information on evidence-based information.

Following are the three methods by which a pharmaceutical sample can be analyzed.

The manual method of analysis: Taste, smell, texture, color, and appearance are some of the organoleptic qualities that the senses can perceive.

Chemical method of analysis: There are various methods available for analyzing the samples as well as titrations and microbiological tests (antibiotics). This method of analysis falls under the chemical approach as reagents are chained together in chain reactions.

Instrumental analysis method: A sample can be evaluated using multiple instrumental techniques such as UV spectroscopy, HPLC, fluorescence, atomic absorption spectroscopy, polarography, gravimetry, NMR, infrared spectroscopy, etc.

It is possible to categorize pharmaceutical analysis into two types:

Qualitative analysis: The number one priority of any scientist is to identify the sample; qualitative analysis involves determining what kind of chemical compounds are present, such as elucidating a molecule's structure and determining its molecular weight when present in samples.

Quantitative analysis: Quantitative or quantitative evaluations of the component quantities, weights, or concentrations in the sample are also done.

Pharmaceutical analysis scope

A Career in Pharmaceutical Analysis Requires a Certain Level of Education
  • To become a Pharmaceutical Analyst, students must possess knowledge in the following areas: biology, chemistry, physics, and mathematics.
  • The ideal candidate for the position of Pharmaceutical Analyst will possess a degree in Pharmaceutical Analysis, Pharmacology, Chemistry, or any related subject.
  • For higher positions, companies may prefer candidates with postgraduate degrees or doctorates in a related field and work experience.
  • For a Pharmaceutical Analyst to succeed, he or she needs to possess extensive theoretical and practical knowledge.
Various types of qualitative and quantitative analysis are required in the manufacturing industry to determine whether raw materials meet certain specifications and to verify the quality of final products. To ensure raw materials are free of unusual substances that might impede the manufacturing process or appear as harmful impurities in the final product, raw materials will be examined to see if the essential components are present within the predetermined range of composition.

Suppose you are developing a new product that contains a mixture other than pure material. In that case, you must determine the right composite composition to achieve the optimum characteristics for which the new material has been developed. In order to perform geographical surveys, soil samples and numerous rock samples must be analyzed. Many industrial processes can produce pollutants that are harmful to health. To assess the level of pollution and establish safe limits for pollutants, air, water, and soil samples must be analyzed quantitatively.

Pharmaceutical analysis has a wide range of applications, including:
  • Classification of a compound according to its chemical properties.
  • Analysis of mixtures for compounds.
  • Separating components from mixtures.
  • Purification, identification, and characterization of compounds.
Since pharmaceuticals play a vital role in the health of individuals, pharmaceutical analysis and quality control are highly regarded in pharmaceutical industries. Their quality aspects determine the quality of drugs. Substandard drugs are those that are deviant in these aspects. During the conversion stage, the quality of the raw materials involved in the conversion is assessed. The process continues until the finished product is evaluated.

In manufacturing, products need to be made to meet the pharmacopeia specifications, and the quality of drugs should comply with the standards. In addition, safety and efficacy requirements for drugs should be met. Thus, the quality of all these pharmaceuticals is evaluated through various quality control methods.

A chemical is said to be chemically pure when it does not contain any impurities or contaminants. The manufacturing process makes it difficult to achieve 100% chemical purity, but the results are worth it.

It is possible, however, to achieve optimum purity if you pay special attention to the introduction process. These chemicals contain impurities that may interfere with the action of the drugs. Therefore, before selecting and using them, it is essential to ensure that they are pure. To decide a substance's purity, certain prescribed standards exist. Official monographs in pharmacopeia prescribe these standards.

Pharmaceutical analysis is defined in two different ways: it consists of various techniques which fall into two broad categories:
  • In qualitative analysis, the component to be analyzed is identified whether it is present or absent in the sample to be analyzed.
  • This category of analysis involves determining the number of compounds in the sample in a quantitative way.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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