Manager is responsible for reviewing and approving the results before they are used in the production process.

5. Procedure

5.1 Sample Preparation

1. Weigh a representative sample of the excipient (usually 100 mg to 200 mg) from the batch for FTIR analysis.
2. Ensure that the sample is homogeneous and free from contamination.
3. For powdered excipients, mix with potassium bromide (KBr) at a ratio of 1:100, if required, and compress the mixture into a pellet using a hydraulic press. For liquids, no further preparation may be needed other than placing a few drops onto the FTIR sampling plate.
4. For tablets, crush the tablet and prepare a sample as described above.

5.2 FTIR Instrument Setup

1. Ensure that the FTIR instrument is calibrated and functioning correctly. Perform a background scan to check the instrument’s baseline.
2. Set the instrument parameters, such as the spectral range (typically 4000 cm^-1 to 400 cm^-1) and resolution (usually 4 cm^-1), according to the standard method or product specifications.
3. Prepare the FTIR sampling area, ensuring the sample holder is clean and free from residues.

5.3 Performing FTIR Analysis

1. Place the prepared sample in the FTIR instrument’s sample holder and initiate the analysis process.
2. Run the analysis, which will generate an infrared spectrum that corresponds to the molecular vibrations of the sample.
3. Ensure the scan is repeated several times (typically 16 scans) to obtain a high-quality spectrum.
4. Record the FTIR spectra for analysis and interpretation. Ensure that the spectrum is clear, with no overlapping peaks that could hinder the identification of the excipient.

5.4 Data Interpretation

1. Compare the obtained FTIR spectrum to the reference spectrum of the excipient to confirm its identity.
2. Check for characteristic peaks specific to the excipient. The absence or alteration of expected peaks may indicate contamination or improper formulation.
3. Evaluate the spectrum for any impurities or unidentified peaks that could affect the excipient’s quality and the final tablet formulation.
4. Document all relevant data, including sample preparation details, instrument settings, and the interpretation of the FTIR spectrum.

5.5 Acceptance Criteria

1. The FTIR spectrum should match the reference spectrum for the excipient with minimal deviation in peak positions and intensities.
2. Any significant differences between the sample spectrum and the reference spectrum must be investigated and documented in the deviation report (Annexure-1).
3. If the spectrum does not meet the expected criteria, initiate corrective actions, which may include re-analysis, additional testing, or sourcing a new excipient batch.

5.6 Documentation and Record-Keeping

1. Document all FTIR analysis results, including the spectra obtained, sample identification, and the comparison with reference spectra, in the batch record (Annexure-2).
2. Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
3. Maintain raw data, including FTIR spectra and calibration data, for regulatory compliance and future reference.

5.7 Post-Test Actions

1. Clean the FTIR sampling area and the sample holder after each use to avoid cross-contamination between tests.
2. Dispose of any sample material and reagents according to the company’s waste disposal procedures.
3. Ensure that the FTIR instrument is maintained and calibrated according to the instrument’s SOP to ensure accurate results for future analyses.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• FTIR: Fourier Transform Infrared
• API: Active Pharmaceutical Ingredient

7. Documents

1. Batch Record (Annexure-2)
2. Deviation Report (Annexure-1)

8. References

• USP <1970> – Infrared Spectroscopy for Pharmaceutical Analysis
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – FTIR Analysis Specifications

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	FTIR pattern did not match reference	Reanalyzed with new sample	John Doe

Annexure-2: Batch Record

Batch Number	Excipient	FTIR Spectrum ID	Comparison with Reference Spectrum	Result
Batch 001	Excipient X	XRDSpectrum_001	Match with Reference	Pass

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Analysis Procedure	Refined FTIR method	QA Head