Optical Rotation Test

Optical rotation test is a cornerstone of chiral analysis in pharmaceuticals, providing essential data for quality control, regulatory compliance, and research and development. Protheragen-ING Lab is committed to delivering precise and dependable optical rotation testing services to support your pharmaceutical projects.

About optical rotation of drugs

In the context of pharmaceuticals, optical rotation can provide important information about the molecular structure and stereochemistry of an active ingredient. Many drugs are chiral molecules whose enantiomers can exhibit different biological activities. The optical rotation of a drug can indicate the specific enantiomeric form present.

Fig. 1 Structures of chiral drugs^[1].

Importance of optical rotation in pharmaceuticals

• Chiral purity assessment: Optical rotation testing helps to assess the chiral purity of these compounds to ensure that the desired therapeutic effect is achieved.
• Quality Control: Regular optical rotation measurements are part of the quality control process and are used to confirm the consistency and purity of drug product batches.
• Regulatory Compliance: Compliance with regulatory guidelines from organizations such as the FDA and EMA often requires detailed optical rotation data to support drug approval applications.

Protheragen-ING Lab's testing capabilities

We provide comprehensive optical rotation testing services utilizing state-of-the-art polarimeters. A polarimeter shines polarized light onto a sample and measures the optical rotation. The magnitude and direction of the optical rotation can provide insight into the stereochemistry and purity of a drug. Our skilled analysts ensure that measurements are accurate and reliable and adhere to strict quality standards. Our services include:

a. Routine Optical Rotation Testing: for raw materials, intermediates, and final products.

b. Method Development and Validation: Customization of test methods to meet specific customer requirements.

c. Regulatory Support: Detailed reports are provided to support regulatory submissions.

Applications of optical rotation test

Identification of Compounds

Determining the optical rotation of a substance can help in identifying it by comparing the measured specific rotation with known values from the literature.

Verification of Enantiomeric Purity

Optical rotation measurements can verify the enantiomeric purity of chiral compounds, which is crucial for the development of enantiomerically pure drugs.

Monitoring Stability

Changes in optical rotation can indicate alterations in the chemical structure of a compound over time, making it a valuable tool for stability testing.

For more information on our optical rotation test services or to request a quote, please contact us.