SPDS SET 2: ASH-01

Sl. No.

Contents

Page No.

1.0]

Summary

3 – 5

1.1)

Introduction

3 – 4

1.2)

Summary report of validation

5

2.0]

Introduction

6 – 8

2.1)

Objective

6

2.2)

Scope

6

2.3)

Purpose and application

6

2.4)

Procedure

7

2.5)

HPLC method

7 – 8

3.0]

Materials and methods

9 – 11

3.1)

Solvents

9

3.2)

Chemicals and their details

9

3.3)

Equipments

10 – 11

3.4)

Miscellaneous

11

4.0]

Validation of instrumental parameters

12 – 60

4.1)

Specificity

12 – 21

4.2)

Linearity

22 – 32

4.3)

Precision

33 – 44

4.4)

Reproducibility of results

45 – 46

4.5)

Accuracy

47 – 52

4.6)

Ruggedness

53 – 54

4.7)

Range of quantification

55 – 58

4.8)

System suitability

59 – 60

5.0]

Stability of sample solution

61

6.0]

Validation Result (Conclusion)

62 – 63

7.0]

Revalidation criteria

64

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