| Monograph Title |
Monograph Section |
Scientific Liaison |
| <130> PROTEIN A QUALITY ATTRIBUTES
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Introduction
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| <130> PROTEIN A QUALITY ATTRIBUTES
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PROTEIN A
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| <130> PROTEIN A QUALITY ATTRIBUTES
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rPROTEIN A, C-CYS
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| <130> PROTEIN A QUALITY ATTRIBUTES
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rPROTEIN A
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| <130> PROTEIN A QUALITY ATTRIBUTES
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rPROTEIN A, B4, C-CYS
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| <381> ELASTOMERIC CLOSURES FOR INJECTIONS PF 30(1) Pg. 220
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Introduction
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| <381> ELASTOMERIC CLOSURES FOR INJECTIONS PF 30(1) Pg. 220
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Characteristics
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| <381> ELASTOMERIC CLOSURES FOR INJECTIONS PF 30(1) Pg. 220
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Identification Tests
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| <381> ELASTOMERIC CLOSURES FOR INJECTIONS PF 30(1) Pg. 220
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Test Procedures
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<503> ACETIC ACID IN PEPTIDES PF 33(2) Pg. 268
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Title |
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| <503> ACETIC ACID IN PEPTIDES PF 33(2) Pg. 268
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Introduction |
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| <503> ACETIC ACID IN PEPTIDES PF 33(2) Pg. 268
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USP REFERENCE STANDARDS <11> |
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| <503> ACETIC ACID IN PEPTIDES PF 33(2) Pg. 268
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STRONG SODIUM HYDROXIDE SOLUTION
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| <503> ACETIC ACID IN PEPTIDES PF 33(2) Pg. 268
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SOLUTION A
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| <503> ACETIC ACID IN PEPTIDES PF 33(2) Pg. 268
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SOLUTION B
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| <503> ACETIC ACID IN PEPTIDES PF 33(2) Pg. 268
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DILUENT
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| <503> ACETIC ACID IN PEPTIDES PF 33(2) Pg. 268
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STANDARD SOLUTION
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| <503> ACETIC ACID IN PEPTIDES PF 33(2) Pg. 268
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TEST SOLUTION
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| <503> ACETIC ACID IN PEPTIDES PF 33(2) Pg. 268
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CHROMATOGRAPHIC SYSTEM (SEE CHROMATOGRAPHY <621>)
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| <503> ACETIC ACID IN PEPTIDES PF 33(2) Pg. 268
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PROCEDURE
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| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
INTRODUCTION |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
COMPONENTS OF DATA QUALITY |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
ANALYTICAL INSTRUMENT QUALIFICATION PROCESS |
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| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
ROLES AND RESPONSIBILITIES |
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| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
SOFTWARE VALIDATION |
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| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
CHANGE CONTROL |
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| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
AIQ DOCUMENTATION |
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| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
INSTRUMENT CATEGORIES |
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| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
CONCLUSION |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
INTRODUCTION |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
COMPONENTS OF DATA QUALITY |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
ANALYTICAL INSTRUMENT QUALIFICATION PROCESS |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
ROLES AND RESPONSIBILITIES |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
SOFTWARE VALIDATION |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
CHANGE CONTROL |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
AIQ DOCUMENTATION |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
INSTRUMENT CATEGORIES |
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| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
CONCLUSION |
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| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
INTRODUCTION |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
COMPONENTS OF DATA QUALITY |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
ANALYTICAL INSTRUMENT QUALIFICATION PROCESS |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
ROLES AND RESPONSIBILITIES |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
SOFTWARE VALIDATION |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
CHANGE CONTROL |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
AIQ DOCUMENTATION |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
INSTRUMENT CATEGORIES |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(2) Pg. 595 |
CONCLUSION |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(6) Pg. 1784 |
INTRODUCTION |
|
| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(6) Pg. 1784 |
COMPONENTS OF DATA QUALITY |
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| <1058> ANALYTICAL INSTRUMENT QUALIFICATION PF 32(6) Pg. 1784 |
ANALYTICAL INSTRUMENT QUALIFICATION PROCESS |
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| <1087> INTRINSIC DISSOLUTION PF 33(2) Pg. 269
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Title
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| <1087> INTRINSIC DISSOLUTION PF 33(2) Pg. 269
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Introduction
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| <1087> INTRINSIC DISSOLUTION PF 33(2) Pg. 269
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APPARATUS
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| <1087> INTRINSIC DISSOLUTION PF 33(2) Pg. 269
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TEST PREPARATION
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| <1087> INTRINSIC DISSOLUTION PF 33(2) Pg. 269
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PROCEDURE
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| <1087> INTRINSIC DISSOLUTION PF 33(2) Pg. 269
|
Introduction
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| <1087> INTRINSIC DISSOLUTION PF 33(2) Pg. 269
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EXPERIMENTAL PROCEDURE
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| <1087> INTRINSIC DISSOLUTION PF 33(2) Pg. 269
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DATA ANALYSIS AND INTERPRETATION
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