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PHASE 1 INVESTIGATION REPORT FOR ASSAY FAILURE IN AMLODIPINE TABLETS 10 MG

PHASE 1 INVESTIGATION REPORT FOR ASSAY FAILURE IN AMLODIPINE TABLETS 10 MG
PHASE 1 INVESTIGATION REPORT FOR ASSAY FAILURE IN AMLODIPINE TABLETS 10 MG

INVESTIGATION REPORT

PHASE 1 INVESTIGATION REPORT

Subject: Assay Failure Investigation for Amlodipine Tablets 10 mg – Phase 1(Laboratory Investigation)

Product Name: Amlodipine Tablets 10 mg

Batch No.: [Insert Batch Number]

Date of Observation: [Insert Date]

Reported Assay Result: 88.0%

Specification Limit: 90.0% to 110.0%

Assay Failure Investigation for Amlodipine Tablets 10 mg – Phase 1 (Laboratory Investigation)

Key Parameter of Below Page:

Hardness Failure During In-Process Check at Compression Stage

Find below pages for complete report

Assay Failure Investigation for Amlodipine Tablets 10 mg – Phase 1 (Laboratory Investigation)

Key Parameter of Below Page:

Hardness Failure During In-Process Check at Compression Stage

Find below pages for complete report

Assay Failure Investigation for Amlodipine Tablets 10 mg – Phase 1 (Laboratory Investigation)

Key Parameter of Below Page:

Hardness Failure During In-Process Check at Compression Stage

Find below pages for complete report

Assay Failure Investigation for Amlodipine Tablets 10 mg – Phase 1 (Laboratory Investigation)

Key Parameter of Below Page:

Hardness Failure During In-Process Check at Compression Stage

Find below pages for complete report

Assay Failure Investigation for Amlodipine Tablets 10 mg – Phase 1 (Laboratory Investigation)

Key Parameter of Below Page:

Hardness Failure During In-Process Check at Compression Stage

Find below pages for complete report

Assay Failure Investigation for Amlodipine Tablets 10 mg – Phase 1 (Laboratory Investigation)

Assay Failure Investigation for Amlodipine Tablets 10 mg – Phase 1 (Laboratory Investigation)

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