is applicable to the Quality Control (QC) department involved in testing of all sterile injectable products manufactured at the facility. It covers routine analysis, stability studies, and investigational impurity profiling.

3. Responsibilities

• QC Analyst: Execute impurity profiling tests and ensure accurate documentation.
• QC Supervisor: Review test data and interpret results for regulatory compliance.
• QA Department: Approve reports, investigate OOS/OOT results, and ensure SOP adherence.
• Instrument Technician: Ensure instruments like HPLC and GC are calibrated and operational.

4. Accountability

The Head – Quality Control is accountable for the execution, review, and documentation of impurity profiling activities.

5. Procedure

5.1 Impurity Classification

1. Organic Impurities – process-related or degradation products
2. Inorganic Impurities – reagents, ligands, heavy metals
3. Residual Solvents – as per ICH Q3C guidelines

5.2 Instrumentation and Equipment

• HPLC system with UV/ELSD/RI/PDA detectors
• Gas Chromatograph with FID/TCD
• Analytical Balance (0.1 mg accuracy)
• pH meter, Sonicator, Auto-sampler
• Validated software for data acquisition (e.g., Empower, Chromeleon)

5.3 Reference Standards

1. Use pharmacopeial or certified in-house reference standards.
2. Store under recommended conditions (Annexure-1: Reference Standard Log).
3. Document usage and expiry verification in test worksheet.

5.4 Sample Preparation

1. Withdraw required volume (as per method) of sample under aseptic conditions.
2. Filter through 0.22 μm membrane if required.
3. Prepare blanks, standards, and spiked recovery solutions.

5.5 Analytical Testing

5.5.1 Organic Impurity Profiling (HPLC)

1. Set column temperature, flow rate, and mobile phase as per validated method.
2. Inject blank, standard, sample, and recovery solution.
3. Calculate % impurities and total impurities.

5.5.2 Residual Solvent Analysis (GC)

1. Prepare standard and sample vials with internal standard.
2. Inject into GC with appropriate column (e.g., DB-624).
3. Quantify residual solvents per ICH Q3C limits.

5.5.3 Inorganic Impurity Analysis

1. Use appropriate colorimetric method or ICP-MS if applicable.
2. Record observations and confirm results against specification.

5.6 Acceptance Criteria

• Total impurities < NMT 2.0%
• Any unidentified impurity < NMT 0.2%
• Any individual known impurity < NMT 0.5%
• Residual solvents: Class I – NMT 2 ppm, Class II/III – as per ICH

5.7 OOS/OOT Handling

1. Initiate deviation and investigation as per QA protocol.
2. Reanalyze sample if required, under QA supervision.
3. Document final disposition based on risk assessment.

5.8 Documentation

1. Record all chromatograms, observations, and peak integrations in Annexure-2: Test Data Sheet.
2. Compile a summary report (Annexure-3) with chromatographic data and interpretations.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• HPLC: High Performance Liquid Chromatography
• GC: Gas Chromatography
• FID: Flame Ionization Detector
• OOS: Out of Specification
• OOT: Out of Trend

7. Documents

1. Reference Standard Log – Annexure-1
2. Test Data Sheet – Annexure-2
3. Impurity Profiling Report – Annexure-3

8. References

• ICH Q3A/B – Impurities in New Drug Substances/Products
• ICH Q2(R1) – Validation of Analytical Procedures
• USP/NF General Chapters <621>, <467>

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: Reference Standard Log

Standard Name	Lot No.	Expiry Date	Storage	Checked By
Impurity A	IMPA-011	15/08/2026	2–8°C	S. Sridhar

Annexure-2: Test Data Sheet

Sample ID	Impurity	RT (min)	Area %	Status
INJ1202	Impurity B	4.22	0.38	Pass

Annexure-3: Impurity Profiling Report

Batch No.	Total Impurities (%)	Unidentified (%)	Decision	Reviewer
B240612	1.56	0.12	Complies	Neha T.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
24/06/2025	2.0	Included residual solvent and impurity reporting formats	Annual SOP Review	QA Head