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  • Akba 35% HBD

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    Ritesh Pune
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    This document provides the finished product specification for Boswellia serrata extract containing 35% acetyl keto-β-boswellic acid. It outlines physical parameters including description, identification, moisture content, solubility, pH, and sieve test requirements. Chemical parameters such as acetyl keto-β-boswellic acid content and total identified β-boswellic acids are specified. Microbiological limits for total plate count, mold, yeast, E. coli, salmonella and other pathogens are also defined. The extract must be GMO free, non-irradiated, and shelf stable for 3 years.

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    AKBA 35% HBD

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    This document provides the finished product specification for Boswellia serrata extract containing 35% acetyl keto-β-boswellic acid. It outlines physical parameters including description, identification, moisture content, solubility, pH, and sieve test requirements. Chemical parameters such as acetyl keto-β-boswellic acid content and total identified β-boswellic acids are specified. Microbiological limits for total plate count, mold, yeast, E. coli, salmonella and other pathogens are also defined. The extract must be GMO free, non-irradiated, and shelf stable for 3 years.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    Download as pdf or txt
    56 views2 pages

    Akba 35% HBD

    Uploaded by

    Ritesh Pune
    This document provides the finished product specification for Boswellia serrata extract containing 35% acetyl keto-β-boswellic acid. It outlines physical parameters including description, identification, moisture content, solubility, pH, and sieve test requirements. Chemical parameters such as acetyl keto-β-boswellic acid content and total identified β-boswellic acids are specified. Microbiological limits for total plate count, mold, yeast, E. coli, salmonella and other pathogens are also defined. The extract must be GMO free, non-irradiated, and shelf stable for 3 years.

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    © All Rights Reserved
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    of 2

    QUALITY CONTROL DEPARTMENT

    Revision: R0
    BOSWELLIA SERRATA EXTRACT AKBBA 35% HBD Date: 09.02.2018
    Review Date: 08.02.2020

    FINISHED PRODUCT SPECIFICATION

    General Information:
    Botanical name : Boswellia serrate
    Plant Part: Gum resin exudates
    Parameters Specification
    Physical Parameters:
    Description *Creamish white to pale brown colored powder with
    characteristic odor.
    Identification To comply by HPLC
    Moisture content Not more than 8.0%
    Solubility Soluble in alcohol & Insoluble in water
    pH ( 1% w/v suspension) Between 4.0 and 6.0
    Specific Optical Rotation Not less than +40º on anhydrous basis
    Residue on ignition Not more than 5.0%
    Melting range Not less than 100°C
    Tapped Bulk Density Between 0.60 g/ml and 1.00 g/ml
    Loose Bulk Density Between 0.20 g/ml and 0.50 g/ml
    Sieve test (passes through)
    - 40 mesh Not less than 100.0%

    Chemical Parameters:
    Acetyl Keto- β-Boswellic acid by HPLC Not less than 35.0% on dried basis
    Total identified β-Boswellic acids by
    HPLC Not less than 45% on dried basis
    Total organic acids as Boswellic acid by
    Not less than 75% on anhydrous basis
    Titration

    Others:
    Heavy metals Not more than 10ppm
    Arsenic Not more than 1ppm
    Lead Not more than 3ppm
    Cadmium Not more than 1ppm
    Mercury Not more than 0.1ppm
    Residual solvents To comply as per ICH/USP/EP

    1|Page
    QUALITY CONTROL DEPARTMENT
    Revision: R0
    BOSWELLIA SERRATA EXTRACT AKBBA 35% HBD Date: 09.02.2018
    Review Date: 08.02.2020

    Microbiological Profile:
    Total Plate Count Not more than 5000cfu/g
    Mold & Yeast Not more than 100cfu/g
    E.coli Negative/10g
    Salmonella Negative/25g
    Staphylococcus aureus Negative/10g
    Pseudomonas aeruginosa Negative/10g

    Additional Information
    Genetic Modification status GMO free
    Irradiation status Non-irradiated
    BSE/TSE status BSE/TSE free
    Shelf life 3 years
    Storage condition Store at room temperature.
    Manufactured by Bioprex Labs
    Ambience, 999 Sadashiv Peth,
    Nr. Bramhan Karyalay,
    Pune 411030
    Country of origin India

    *Since it is a herbal product, there is likely to be minor color variation because of the
    geographical and seasonal variations of the raw material

    HBD* - High bulk density

    Prepared by: Approved by:

    QA Executive: QA Manager:

    Mahalaxmi Nair Veena.B.R

    2|Page

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