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BRIFING
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BACKGROUND
GENERATING THE EXTRACT
EXTRACTING MEDIUM
EXTRACTION TIME & TEMP
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Example Extractables Profiles—Materials Chara
USP 1664
PURPOSE
KEY TERMS
BACKGROUND
CONCEPTS
SAFETY THRESHOLDS
LEACHABLES STUDY DESIGN
LEACHABLES CHARACTERIZATION
SAMPLE PREPARATION
VALIDATION
LEACHABLES–EXTRACTABLES CORRELATION
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KEY TERMS
LEACHABLES ASSESSMENT
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CONSIDERATIONS
ICH Q3E
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Practices and Challenges
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BPOG RA section
USP1665 RA section
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PART III Best Practices for E&L Asseessment i
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한국식약처고시
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Sterile Filter E&L - EU GMP Annex1
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Genotoxic Impurity
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SAINT-GOBAIN
TUBING SELECTION GUIDE
ValPlus™ Tubing Validation Certification
C-Flex® TPE
Sani-Tech® STHT-65 and STHT-C
Sani-Tech® Ultra-65 and Ultra-C
Sani-Tech® SPT-60L Pump Tubing
Sani-Tech® Sani-Link®
Sani-Tech® STHT®-WR
PharMed® BPT
SANIseal
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Genotoxic Impurity
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Nitrosamine
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SAINT-GOBAIN
TUBING SELECTION GUIDE
ValPlus™ Tubing Validation Certification
C-Flex® TPE
Sani-Tech® STHT-65 and STHT-C
Sani-Tech® Ultra-65 and Ultra-C
Sani-Tech® SPT-60L Pump Tubing
Sani-Tech® Sani-Link®
Sani-Tech® STHT®-WR
PharMed® BPT
SANIseal
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