involved in analytical testing of all injectable solutions produced at the manufacturing site. It includes the usage of spectroscopic techniques for both in-process and finished product analysis.

3. Responsibilities

• QC Analyst: Perform and document the spectroscopic analysis.
• QC Supervisor: Review and verify analytical data.
• QA Officer: Ensure compliance with procedures and approve results.
• Instrument Technician: Maintain and calibrate spectroscopic instruments.

4. Accountability

The Head of Quality Control is accountable for implementation and execution of this SOP.

5. Procedure

5.1 Types of Spectroscopic Techniques

1. UV-Visible Spectroscopy: For quantitative analysis and impurity detection.
2. FTIR (Fourier Transform Infrared Spectroscopy): For identification of functional groups and compatibility studies.
3. NIR (Near Infrared Spectroscopy): For rapid, non-destructive testing, typically used in PAT applications.

5.2 Instrumentation

• UV-Vis Spectrophotometer (range 190–800 nm)
• FTIR Spectrometer with ATR module
• NIR Spectrometer with fiber optic probe
• Computer with validated software (e.g., UVProbe, Spectrum, Vision)

5.3 Sample Preparation

1. Ensure sample is clear and free of particulates. Filter if needed using 0.22 µm filter.
2. Use appropriate blank solution (e.g., Water for Injection, diluent).
3. Prepare standard solutions according to the method SOP.
4. Label all sample cuvettes or vials appropriately.

5.4 Method of Analysis

5.4.1 UV-Visible Analysis

1. Switch on UV-Vis system and allow warm-up (typically 30 min).
2. Run baseline with blank.
3. Scan standard and sample from 200–400 nm as applicable.
4. Record absorbance at specified λmax for quantitative results.
5. Use Beer’s Law for concentration determination.

5.4.2 FTIR Analysis

1. Ensure the ATR crystal is clean and dry.
2. Place a few drops of liquid sample on the crystal.
3. Record the IR spectrum in 4000–400 cm⁻¹ range.
4. Compare with reference spectrum for identity verification.

5.4.3 NIR Analysis

1. Use pre-calibrated model if available.
2. Position the fiber probe into the sample vial.
3. Scan over 1000–2500 nm range.
4. Obtain spectral match or quantitative readout from software.

5.5 Acceptance Criteria

• Spectrum should match the reference standard (≥ 90% match).
• Absorbance readings must fall within the validated range.
• Deviation in spectra must be investigated and documented.

5.6 System Suitability

1. Run system suitability standard before sample analysis.
2. Ensure baseline drift, resolution, and absorbance fall within limits.

5.7 Data Handling and Reporting

1. Save raw data electronically with secure access control.
2. Print and review spectral overlay and results.
3. Record all observations in Annexure-1: Spectroscopy Test Data Sheet.

5.8 Cleaning and Shutdown

1. Clean cuvettes or ATR crystals with methanol or suitable solvent.
2. Switch off instrument as per manufacturer’s SOP.
3. Log usage and shutdown time in instrument usage log.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• UV: Ultraviolet
• IR: Infrared
• NIR: Near Infrared
• FTIR: Fourier Transform Infrared Spectroscopy

7. Documents

1. Spectroscopy Test Data Sheet – Annexure-1
2. Spectral Comparison Report – Annexure-2
3. Instrument Usage Log – Annexure-3

8. References

• ICH Q2(R1): Validation of Analytical Procedures
• USP General Chapters <857>, <858>, <1856>
• Instrument Manufacturer’s User Manual

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QC Analyst	QA Executive	Head QA
Department	Quality Control	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Spectroscopy Test Data Sheet

Sample ID	Type	λmax (nm)	Absorbance	Status
INJ325	UV	276	0.582	Pass

Annexure-2: Spectral Comparison Report

Sample ID	Reference Match (%)	Result	Analyst
INJ325	96.2%	Complies	Anjali Desai

Annexure-3: Instrument Usage Log

Date	Instrument	Start Time	End Time	User
24/06/2025	FTIR-01	09:00	11:00	Ravi Kumar

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial Release	New Procedure	QA Head
24/06/2025	2.0	Updated to include NIR procedures and new annexures	Annual SOP Review	QA Head