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  • Acceptance Criteria Applicable

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    Sameer Goyal
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    The document outlines acceptance criteria for validation parameters including specificity, linearity, accuracy, precision, LOD, LOQ, and ranges for assay/active constituents, contaminants/residues, precision, accuracy by recovery, and linearity. It also lists possible variations that could be tested for robustness of HPLC and GC methods, such as changes in pH, mobile phase composition, temperature, flow rate, and wavelength for HPLC, and column, temperature, and flow rate for GC.

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    Acceptance Criteria Applicable (2)

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    The document outlines acceptance criteria for validation parameters including specificity, linearity, accuracy, precision, LOD, LOQ, and ranges for assay/active constituents, contaminants/residues, precision, accuracy by recovery, and linearity. It also lists possible variations that could be tested for robustness of HPLC and GC methods, such as changes in pH, mobile phase composition, temperature, flow rate, and wavelength for HPLC, and column, temperature, and flow rate for GC.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as docx, pdf, or txt
    13 views2 pages

    Acceptance Criteria Applicable

    Uploaded by

    Sameer Goyal
    The document outlines acceptance criteria for validation parameters including specificity, linearity, accuracy, precision, LOD, LOQ, and ranges for assay/active constituents, contaminants/residues, precision, accuracy by recovery, and linearity. It also lists possible variations that could be tested for robustness of HPLC and GC methods, such as changes in pH, mobile phase composition, temperature, flow rate, and wavelength for HPLC, and column, temperature, and flow rate for GC.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as docx, pdf, or txt
    of 2

    Acceptance criteria for various validation parameters

    1) Validation Characteristics & Requirements Validation Parameter Specificity Linearity Accuracy Precision LOD LOQ Assay/active constituent range 2 100% Yes Yes Yes Yes No No Assay/Active constituent range 0.1 1% Yes Yes Yes Yes No Yes Contaminants/ Residues <0.1% Yes Yes Yes Yes Yes Yes

    2) Precision Active ingredient content in sample 10.0 % 1.0 to 10.0% 0.1 to 1.0% < 0.1% RSD limit 2% 5% 10% 20%

    3) Accuracy by Recovery Active ingredient content in sample 10.0 % 1.0 to 10.0% 0.1 to 1.0% < 0.1% Acceptable mean recovery 98 102% 90 110% 80 120% 75 125%

    4) Linearity Parameter Assay Assay, Herbal matrix Content uniformity Contaminants/residues Linearity range 80 120% ( 5 points) 70 130% (7 points) 70 130% (5 points) Reporting level to 120% (5 points)

    5) Possible Variations for carrying out robustness For HPLC analysis pH Mobile phase composition (change in organic phase ) Temperature Flow rate Wave length, 5nm For GC analysis Column (different supplier) Temperature Flow rate (gas)

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