Mannitol 10%

Mannitol 10 % Intravenous
Infusion W/V BP
Page 1 of 10
Table of contents:
Titles
1. Objective.
2. Scope.
3. Responsibility.
4. Method description.
5. Analytical performance characteristics and acceptance criteria.
6. Procedure:
6.1 Linearity of assay of Mannitol.
6.2 Precision of assay of Mannitol.
6.3 Accuracy and recovery of assay of Mannitol.
7. Final report, conclusion and approval.
Page 2 of 10
1. OBJECTIVE:
To prove that the analytical method of intravenous Solutions is suitable for its intended use.
2. SCOPE:
2.1. Analytical method of assay Mannitol 10%w/v injection.
3. RESPONSIBILITY:
3.1. Q.C analyst is responsible for implementation the protocol.
3.2. Q.C head section is responsible for reviewing the protocol and result.
3.3. QC manager is responsible for reviewing and approval of the Protocol and the final report.
4. METHOD DESCRIPTION:
4.1. Method.
4.1.1. this report describe the validation of titration method assay of mannitol 10%injection
4.2. Analytical standard

4.2.1. Mannitol
4.3. Reagents
4.3.1. Iodine 0.5 N volumetric solution.
4.3.2. Sodium arsenite.
4.3.3. Sodium periodate.
4.3.4. Potassium iodide.
5. ANALYTICAL PERFORMANCE CHARACTERISTICS AND ACCEPTANCE CRITERIA :
Parameter Acceptance criteria Reference

Linearity R  0.997 ICH
Precision [and RSD  2% or as specified in the analytical
ICH
repeatability monograph
Accuracy and recovery RSD ICH
Page 3 of 10
6. PROCEDURE
6.1. linearity of method assay of mannitol 10%
Section I: Identification
Product Mannitol 10% injection Date 16-1-2011
 By Titration Titrant name Iodine
Linearity procedure
 By Instrument Instrument Cal #
Standard name Mannitol Standard lot 30501
Reference # QP051 Sample size 6
Linearity Correlation co-efficient (r) > 0.997; within the range specified by the ICH
Acceptance criteria [80 %– 120 %]
Section II: Testing Procedure

1. Prepare different 6 concentrations of the standard mentioned above.
2. Refer to the test procedure of the product mentioned above.
Section III: Tabulated Results

Concentration (%)
90 89.00
95 94.34
100 99.50
105 104.50
110 109.80
115 114.40
r = 0.9998
Page 4 of 10
Section III: Approval
Name Date Signature
Analyst
Checked by
Approved by
Page 5 of 10
6.2. precision [repeatability] of method assay of mannitol10%
Product Mannitol 10% injection Date 16-1-2011
Precision method
Acceptance criteria RSD < 2%

 Measure the concentration of 6 different samples of 100% concentration.

Concentration (%) Actual Concentration (%)
99.50
99.60
99.45
100
99.40
99.50
99.70
RSD = 0.11

Name Date Signature
Analyst
Checked by
Approved by
Page 6 of 10
6.2.1. Precision [reproducibility] of method assay of mannitol10%
Mannitol 10% injection 17-1-2011

Product Date
18 – 1- 2011
Precision method
Acceptance criteria RSD < 3%
1. Conclude the Reproducibility over analysts and days by preparing 6 different preparations of
100% concentration per each variant.
Actual Concentration (%) Actual Concentration (%)
Concentration (%) Analyst A Analyst B
Day 1 Day 2 Day 1 Day 2
101.0 100.85 100.0 101.0
101.5 100.50 101.0 101.0
101.0 101.00 101.5 101.5
100
100.8 101.00 101.2 101.5
100.8 100.25 100.8 100.5
100.5 101.00 100.8 102.0
RSD 0.33 0.32 0.5 0.52

RSD = 0.41

Name Date Signature
Analyst
Checked by
Approved by
Page 7 of 10
6.3. accuracy of method assay of Mannitol 10%
Product Mannitol10% injection Date 16-1-2011
Accuracy method
Acceptance
Confidence and Slope are around 1, RSD < 2.
criteria

1. Prepare 3 different concentrations of the standard mentioned above.
2. Prepare 3 samples of the finished product per each concentration mentioned above (9
replicates; 3 weights * 3 concentrations).

Concentration Actual Concentration
Concentration (%) Recovery %
(gm/100ml) (gm/100ml)
9.6 101.5
95 9.5 9.65 100.53
9.65 101.57
10.1 101
100 10 10.1 101
10.0 100
10.4 99.05
105 10.5 10.38 98.86
10.55 100.48
Confidence = 0.242 Slope = 0.843 RSD = 0.92
Page 8 of 10
Name Date Signature
Analyst
Checked by
Approved by
7. Final report, conclusion and approval

Page 9 of 10
The analysis method for assay of Mannitol 10% is BB pharmacopoeias
1. So we just do:
Accuracy, Precision and linearity.
2. The method was found
3. Linear where(r) is greater than 0.99 (0.999997)
4. Accurate where percentage recovery within limit (98-102)
5. precise as the RSD ≤2% and CV ≤2%
So the method is suitable for its intended use.
Repared and Approved by

Dr. Tawhida Salah El-din
Quality Control Manager
Page 10 of 10

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7. Final report, conclusion and approval.

4.2. Analytical standard

5. ANALYTICAL PERFORMANCE CHARACTERISTICS AND ACCEPTANCE CRITERIA :

Parameter Acceptance criteria Reference

Section II: Testing Procedure

Section III: Tabulated Results

Section II: Testing Procedure

Section III: Tabulated Results

Section III: Approval

Mannitol 10% injection 17-1-2011

RSD 0.33 0.32 0.5 0.52

Section III: Approval

Section II: Testing Procedure

Section III: Tabulated Results

Confidence = 0.242 Slope = 0.843 RSD = 0.92

7. Final report, conclusion and approval

So the method is suitable for its intended use.

Repared and Approved by

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