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Appendix D

This document is a standard operating procedure (SOP) for testing binary mixtures in pharmaceuticals. It includes sections for recording data on active pharmaceutical ingredients (API), excipients, and various conditions over time. The document outlines the process for assessing parameters such as loss on drying (LOD), assay, and impurity levels at specified intervals.

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4 views1 page

Appendix D

This document is a standard operating procedure (SOP) for testing binary mixtures in pharmaceuticals. It includes sections for recording data on active pharmaceutical ingredients (API), excipients, and various conditions over time. The document outlines the process for assessing parameters such as loss on drying (LOD), assay, and impurity levels at specified intervals.

Uploaded by

faisal ahmed
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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XXXXX PHARMA LIMITED

PAGE 1 OF 1
ADDRESS

Document No. Issue Date Review Date Superseded Date

SOP/PD/007/01 New

APPENDIX – D
BINARY MIXTURE (TEST DATA)
Name of API:
Name of Excipients:
Condition:
Appearance
Initial 02 weeks 04 weeks
Close Open Close Open

% LOD

Assay

Impurity

Name Designation Signature Date


Prepared by
Reviewed by
Approved by

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