API Tests or Pharmaceutical Tests: How to Understand

Introduction and Outcome: API Tests or Pharmaceutical tests

API Tests or Pharmaceutical tests play a vital role in maintaining quality, safety and efficacy in any pharmaceutical industry. In this article, you will learn the different API tests/Pharmaceutical tests and their importance with FAQs.

API Tests or Pharmaceutical tests

The process of evaluating the suitability (quality, safety and efficacy) of a Pharmaceutical for intended use is called Pharmaceutical tests. When this process is applied to an API then it is called API tests. API Tests or Pharmaceutical tests may include several tests.

Type of API Tests or Pharmaceutical tests

API Tests or Pharmaceutical tests may include several tests such as:

Description
Identification
Solubility
Water content test
LOD test
Optical purity test
Related substances test
Assay test
Purity test
Organic volatile impurity rests or residual solvent tests
Content tests
Residue on Ignition test
Heavy metals test
Limit tests
Polymorphic tests

Description Test

This test confirms whether the pharmaceutical meets with defined description test or not. It is performed on all types of pharmaceuticals (raw materials, intermediates and APIs) and dosage forms. This test is performed by visual inspection.

Identification Test

This test is performed to identify the concerned pharmaceuticals and it is performed on all types of pharmaceuticals (raw materials, intermediates and APIs) and dosage forms. The following techniques are used for identification tests:

At least two identification tests should be kept in any pharmaceutical monograph. Out of two tests, one should be by spectroscopic method and the second may be by chromatographic method or chemical method

Solubility Test

Solubility testing measures the solubility of solid pharmaceuticals in various polar and nonpolar solvents. It is an integral part of the API specifications.

Water content test

The water content test is performed to determine the presence of water in any pharmaceuticals. Generally KF apparatus is used to determine the water in any pharmaceutical.

LOD Test

LOD Test is performed to determine the presence of both water and organic solvent in any pharmaceuticals. Generally, loss on the drying chamber and halogen moisture balance is used to perform the LOD test.

Optical purity test

This test is performed for only chiral pharmaceuticals. The following techniques are used to see optical purity:

Specific optical rotation &
Chiral chromatography

Among the above techniques, chiral chromatography is more specific and accurate.

Related substances/Impurity profile test

This testing is very important to maintain the quality of any drug and it is performed at each stage during drug development. The following techniques are widely used for this test:

HPLC
GC
TLC
LC-MS and
GCMS

Both area-normalisation and external standard methods are used to calculate impurity in related substances tests.

Assay Test

This test is performed to determine the exact content of the pharmaceuticals. It is an integral part of the API specification. For other pharmaceutical, this test may orb may not be kept. It is the quantitative test and the following techniques are used to perform this test:

HPLC
GC and
Titration &
Spectroscopic techniques (UV or FT IR)

Purity test

This is a qualitative test and it is generally performed at pharmaceutical intermediate stages. HPLC and GC are used to perform this test,

Organic volatile impurity rests or residual solvent tests

This test is performed to determine volatile organic solvents in pharmaceuticals. It is an integral part of the API specification. For other pharmaceutical stages may or may not be performed based on rational justification. GC-GS is used to perform this test.

Content tests

This test may be performed at any stage of the pharmaceutical based on the requirement,

Check out this article: Content Test in Pharmaceuticals

Residue on Ignition test

This test is performed to determine the presence of inorganic impurities in the pharmaceuticals. This test is an integral part of the API specification and for other stages, it may or may not be performed based on rational justification. This test is performed at high temperatures using furnace.

Heavy metals test

This test is performed to determine the content of the metallic impurities. Generally, ICIMS is used to perform this test.

Polymorphic tests

This test is performed at the API stage to determine the form. Different forms may have different bioavailability which is why this test is needed. Generally, XRD is used to perform this test.

Check out this article to learn more about XRD: XRD analysis in APIs development

Applications

To maintain the quality, safety and efficacy of the pharmaceuticals

Conclusion

I hope this article has helped you understand API Tests or Pharmaceutical Tests their importance.You may also want to check out other articles on my blog, such as GLP, GMP and Data Integrity.

FAQs

How many tests are kept in identification test?

At least two tests must be kept in the identification test. out of two one should be spectroscopic and the second may be a chromatographic or chemical test.

What are the identity tests for pharmaceutical substances?

Using FT IR, UV spectrophotometer, TLC, HPLC, GC and chemical method identification tests can be kept for any pharmaceutical.

How to test pharmaceutical drugs?

Pharmaceutical drugs can be tested using various techniques like HPLC, GC, GTIR, UV spectrophotometer, GCMS, LCMS etc.

What is the objective of basic test of drugs?

To maintain quality, safety and efficacy drugs are tested

What is the importance of pharmaceutical testing?

Pharmaceutical testing is required to monitor the quality of the pharmaceuticals