Analytical Method Development (AMD) department.

2. Scope

This procedure applies to the development of dissolution methods for solid oral dosage forms (tablets, capsules, and multiparticulates), particularly during early method development and robustness assessment.

3. Responsibilities

• Analytical Scientist: Conducts suitability tests using USP Apparatus I and II at various RPMs and documents results.
• Formulation Scientist: Provides insight on dosage form properties and expected disintegration/release behavior.
• Group Leader: Reviews apparatus selection and RPM data and endorses method settings.
• QA Executive: Verifies documentation and ensures protocol adherence.

4. Accountability

The Head of Analytical Method Development is accountable for approving the selected apparatus and RPM parameters for use in validated dissolution methods.

5. Procedure

5.1 Selection of Dissolution Apparatus

1. Evaluate the physical properties of the dosage form:
   • Tablets that tend to float: Consider USP Apparatus I (Basket)
   • Tablets that sink and disintegrate: Consider USP Apparatus II (Paddle)
   • Multiparticulates or capsules: Evaluate both Apparatus I and II for discrimination
2. Conduct preliminary runs using both apparatus types where uncertainty exists.

5.2 RPM Optimization

1. Perform dissolution runs using 6 units at three RPMs (e.g., 50, 75, 100 rpm).
2. Record % drug release at key time intervals (e.g., 10, 20, 30, 45, 60 min).
3. Analyze the following:
   • Extent of release at early, mid, and final time points
   • Discriminatory power against formulation/process variants
   • Variance (RSD) among units
4. Select RPM that:
   • Achieves target release window (e.g., 80% in 30 min)
   • Minimizes variability
   • Allows visual and statistical discrimination between batches

5.3 Evaluation Criteria

1. Compare dissolution curves between RPM settings (Annexure-1).
2. Calculate f2 similarity values if applicable.
3. Document rationale for selected apparatus and RPM (Annexure-2).

5.4 Finalization

1. Document final conditions:
   • Apparatus type
   • RPM
   • Media volume and type
2. Include in dissolution method SOP and validation protocol.

6. Abbreviations

• SOP: Standard Operating Procedure
• RPM: Revolutions Per Minute
• RSD: Relative Standard Deviation
• f2: Similarity Factor

7. Documents

1. Apparatus and RPM Evaluation Data Sheet – Annexure-1
2. Justification Report for Selected Parameters – Annexure-2
3. Graphical Overlay of Profiles – Annexure-3

8. References

• USP <711> Dissolution
• ICH Q6A: Specifications
• FDA Guidance: Dissolution Testing of Immediate Release Solid Oral Dosage Forms

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Rahul Deshmukh	Neha Menon	Sunita Reddy
Designation	Research Scientist	QA Reviewer	Head – AMD
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: Apparatus and RPM Evaluation Data Sheet

RPM	% Release @ 30 min	RSD (%)	Notes
50	72.1	5.2	Low agitation, incomplete release
75	88.3	3.8	Optimal range, low variability
100	97.5	6.1	Rapid release, high variability

Annexure-2: Justification Report

USP Apparatus II (Paddle) at 75 RPM selected based on uniformity, discrimination capability, and regulatory precedence. Media: pH 6.8 phosphate buffer, 900 mL.

Annexure-3: Graphical Overlay

Dissolution profiles for each RPM plotted and archived under AMD/DISS/RPM/218/2025 with digital signature of approving authority.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Included RSD thresholds and f2 comparison for selection	Annual Review	Sunita Reddy
12/04/2022	1.0	Initial SOP Issuance	New Document	QA Head