Lab 11: Quality Control FT-IR - Pharmaceutics II

What is FT-IR Spectroscopy?

Analytical technique used to obtain the infrared absorption or transmission spectrum of a sample

How is FT-IR used for quality control?

Used to verify the identity and purity of raw materials and finished products, and ensures compliance with regulatory standards

What four ways is FT-IR used for drug formulation?

Helps assess compatibility between APIs and excipients, safeguarding stability and effectiveness of a formulation

Aids in studying drug encapsulation within carriers like Liposomes or Nanoparticles, which helps ensure accurate release profiles

Verifies uniform distribution of APIs and excipients in formulation

Monitors water content in formulations, which helps maintain stability and extend shelf life

How is FT-IR used for Polymorphic Analysis?

Helps in studying different crystalline forms of a drug, which can affect its solubility, bioavailability, and stability

How is FT-IR used for Counterfeit Drug Detection?

Can identify counterfeit drugs by analyzing their chemical composition and comparing them to authentic samples

How is FT-IR used for Inhaled Drug Products?

Used to analyze the sprayed profile of inhaled drugs, ensuring proper distribution and agglomeration of particles

What does FT-IR excel at identifying and quantifying?

Functional Groups with characteristic absorption frequencies

What are six main advantages to FT-IR?

1. SPEED - rapid analysis for quick identification and verification

2. MINIMAL SAMPLE PREPARATION

3. NON-DESTRUCTIVE - can analyze without altering sample

4. VERSATILITY - suitable for solids, liquids, gases, and multiple dosage form

5. QUANTITATIVE AND QUALITATIVE ANALYSIS - identify compounds and measure concentration accurately

6. REGULATORY ACCEPTANCE - widely recognized and accepted for pharmaceutical testing

What are four main disadvantages to FT-IR?

1. SENSITIVITY - struggles to detect components present in very low concentrations (<5%)

2. COMPLEX MIXTURES - overlapping absorption bands can make it challenging to distinguish individual components

3. QUANTIFICATION - less effective for precise quantification

4. INSTRUMENT COST - high quality FT-IR instruments can be expensive

What four sampling techniques does FT-IR use to analyze samples?

1. Transmission

2. Attenuated Total Reflection (ATR)

3. Specular Reflection

5. Diffuse Reflectance

What is Transmission technique for FT-IR Sampling?

What types of preparations is it suitable for?

What is required for this technique?

Infrared light passes through the sample and the transmitted light is measured

Suitable for liquids, gases, and thin solid films

Requires sample preparation (pellets or mulls for solids)

What is Attenuated Total Reflection (ATR) technique for FT-IR Sampling?

What types of preparations is it suitable for?

Why is it a popular choice?

Infrared light reflects internally within a crystal, creating an evanescent wave that interacts with the sample

Suitable for solids, liquids, and pastes

Minimal sample preparation is required

What is Specular Reflection technique for FT-IR Sampling?

What types of preparations is it suitable for?

Infrared light scatters of the surface of a powdered or rough sample and the reflected light is analyzed

Suitable for powders and highly scattering samples

What is Diffuse Reflectance technique for FT-IR Sampling?

What types of preparations is it suitable for?

Infrared light reflects off the surface of a smooth, reflective sample

Suitable for analyzing thin films and coatings

What are four main advantages of Attenuated Total Reflection (ATR) technique?

1. Minimal sample preparation

2. Fast and easy cleanup

3. Analysis of samples in their natural states

4. Excellent for thick or strongly absorbing samples

What three structures should be present in the compounded Diphenhydramine HCl Tablet?

What key characteristics can distinguish between the structures if you were to be given one?

1. DIPHENHYDRAMINE HCl

- Double benzene ring, tertiary amine

2. SUCROSE

- 6 ring, 5 ring, lots of alcohols

3. LACTOSE MONOHYDRATE

- two 6 rings, lots of alcohols