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    P18020321 #0 Opq Yl - Opq Yl

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    Zainab abood
    The document is a certificate of analysis for a batch of hard gelatin capsule shells produced by Natural Capsules Limited. It summarizes that: 1) The capsules were manufactured according to cGMP in ISO certified facilities and conform to high quality standards. 2) Comprehensive testing was performed to ensure the capsules met specifications for identity, purity, strength, and other quality attributes. 3) The specific batch of capsules met all tested quality specifications.

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    © All Rights Reserved
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    P18020321 #0 Opq Yl - Opq Yl

    Uploaded by

    Zainab abood
    97 views2 pages
    The document is a certificate of analysis for a batch of hard gelatin capsule shells produced by Natural Capsules Limited. It summarizes that: 1) The capsules were manufactured according to cGMP in ISO certified facilities and conform to high quality standards. 2) Comprehensive testing was performed to ensure the capsules met specifications for identity, purity, strength, and other quality attributes. 3) The specific batch of capsules met all tested quality specifications.

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    P18020321 #0 OPQ YL- OPQ YL

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    The document is a certificate of analysis for a batch of hard gelatin capsule shells produced by Natural Capsules Limited. It summarizes that: 1) The capsules were manufactured according to cGMP in ISO certified facilities and conform to high quality standards. 2) Comprehensive testing was performed to ensure the capsules met specifications for identity, purity, strength, and other quality attributes. 3) The specific batch of capsules met all tested quality specifications.

    Copyright:

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

    P18020321 #0 Opq Yl - Opq Yl

    Uploaded by

    Zainab abood
    The document is a certificate of analysis for a batch of hard gelatin capsule shells produced by Natural Capsules Limited. It summarizes that: 1) The capsules were manufactured according to cGMP in ISO certified facilities and conform to high quality standards. 2) Comprehensive testing was performed to ensure the capsules met specifications for identity, purity, strength, and other quality attributes. 3) The specific batch of capsules met all tested quality specifications.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    NATURAL CAPSULES LIMITED COA No.

    : 040000272690
    Unit-II
    R.S.No.84,Perambai Road Date : 31.03.2018
    Pitchaiveeranpet Batch No. : P18020321
    Pondicherry -605010 India
    A.R. No. : 02/59/18
    BSE/TSE FREE
    CERTIFICATE OF ANALYSIS
    The capsules are produced under very carefully controlled conditions. The product is manufactured
    in accordance with cGMP in an ISO certified plants.Controls are performed continuously throught
    the process and guarantee that capsules conforms to the highest Quality Standards. The capsules
    described below conform to the current specifications.

    To: M/s. MODERN DRUG INDUSTRIES

    Product Description: HARD GELATIN CAPSULE SHELLS IH

    Item Code : N.A Batch No. : P18020321 Size : 0 Page : 1 / 2


    Date of MFG. : MAR/2018 Date of EXP.: FEB/2023 Qty : 5.00 LAC
    Material No : BRPSYL324YL324E10U DL NO.: 25 - 03 13 0996 PO.Date: 19.03.2018
    STP No :FP/STP/001/02 PO.No. : PFI:E-157/2017-18
    CAP BODY
    Color Description : OPQ.YELLOW Color Description : OPQ.YELLOW
    Pantone Code : NA Pantone Code : NA
    NCL Color Code : YL324 NCL Color Code : YL324
    Print Message : N.A Print Message : N.A
    Printing Ink : NA Printing Ink : NA
    Print Type : NA Print Type :NA
    Target Weight : 38.4mg Target Weight : 57.6mg
    COMPOSITION
    Colorants CI.No E.No % Colorants CI.No E.No %
    Quinoline Yellow 47005 104 0.026 Quinoline Yellow 47005 104 0.026
    Sunset Yellow 15985 110 0.070 Sunset Yellow 15985 110 0.070
    Titanium Dioxide IP/USP/IH 77891 171 1.000 Titanium Dioxide IP/USP/IH 77891 171 1.000
    0.000 0.000
    0.000 0.000
    0.000 0.000

    CAP COMPOSITION BODY COMPOSITION


    Gelatin IP/USP/IH Structure Q.S. Gelatin IP/USP/IH Structure Q.S.
    Methyl Paraben Preservative 0.8% Methyl Paraben Preservative 0.8%
    Propyl Paraben Preservative 0.2% Propyl Paraben Preservative 0.2%
    Sodium Lauryl Sulphate IP/USP/IH Surfactant 0.1 Sodium Lauryl Sulphate IP/USP/IH Surfactant 0.1
    Purified Water BP/USP/Ph-Eur Solvent 14.50 Purified Water BP/USP/Ph-Eur Solvent 14.50

    Limitations:Due to Nature of raw materials, their sourcing and technology improvements, the
    material content data indicated are target values and actual values may vary.
    Note:
    1.The visual quality of the product conforms to established AQL's for physical attributes.
    2.Appearance-Clean empty capsules meeting the specified requirements of color and size.
    3.The Bovine empty Gelatin Capsules are made of 100% bovine pharmaceutical gelatin.
    4.This meterial is derived from healthy animals slaughtered in a slaughter house,which have been
    inspected by an official veterinarian and have been fit for human consumption.
    5.Storage conditions: Unopened capsule boxes can be safely stored between 15 & 30C and between
    40 & 65% RH.Avoid wide temperature fluctutions during storage and do not store near a source of
    heat.
    6.Packing profile :Packaging consists of protective, Food grade anti- static poly bags inside
    robust cardboard corrugated boxes with EPS liners/box, as applicable.

    Page 1 / 2
    NATURAL CAPSULES LIMITED COA No. : 040000272690
    Unit-II
    R.S.No.84,Perambai Road Date : 31.03.2018
    Pitchaiveeranpet Batch No. : P18020321
    Pondicherry -605010 India
    A.R. No. : 02/59/18
    BSE/TSE FREE
    TEST SPECIFICATION METHOD RESULT
    Description Unlocked Cylindrical Capsules IP complies
    Identification of Gelatin A precipitate is Produced with Picric Acid or IP complies
    Tannic Acid solution.
    Identification of Organic Conforms to Composition.(if present) IH complies
    Colorants
    Identification of Iron Oxides A deep blue precipitate is produced with IH NA
    Potassium ferrocyanide solution. (if present)
    Identification of Titanium An Orange Red colour is produced with 30% v/v IH complies
    Dioxide Hydrogen Peroxide solution (if present).
    Identification of Complies with the specified Test(if present). IH complies
    Preservatives
    Identification of Sodium Complies with the specified Test.(if present) IH complies
    Lauryl Sulphate
    Average Weight 96 mg ± 7% (89.30 - 102.30)mg IP 99.58mg
    Uniformity of Weight Not more than 2 of individual Capsules deviate IH Complies
    from average by more than ±5% and none of them
    deviate by more than ±10% from average weight.
    Disintegration Time Not more than 15 Minutes IP 6.19min.
    Odour No foreign odour. IP Complies
    Loss on Drying 12.5 % to 16.0 % IP 15.10%
    Brittleness Test Not more than 3 % IH 0%
    Arsenic (in ppm) Not more than 1ppm IH Complies
    Heavy Metals (as Pb in ppm) Not more than 20 ppm IH Complies
    Lubricant Content Not more than 0.5 % w / w IH 0.34%
    Sulphur Dioxide Not more than 50 ppm IH 13.6ppm
    Sulphated Ash Not more than 5 % w/w IH Complies
    MICROBIAL TEST
    Total Aerobic Microbial Count Not more than 300 CFU/g IP 45cfu/gm
    Total Combined Yeast & Mold Not more than 100 CFU/g IP 10cfu/gm
    Count
    Escherichia Coli Absent in 1 g IP Complies
    Salmonella Species Absent in 10 g IP Complies
    Pseudomonas Aeruginosa Absent in 1 g IH Complies
    Staphylococcus Aureus Absent in 1 g IH Complies
    Clostridium Sporogenes Absent in 1g IH Complies
    Bile Tolerant Gram negative Absent in 1 g IH Complies
    bacteria
    Shigella Species Absent in 10 g IP Complies
    Candida Albicans Absent in 1 g IH Complies
    DIMENSIONS
    Outside Diameter Cap :7.57-7.69mm Body:7.26-7.38mm IP Complies
    Length Cap :10.68-11.68mm Body:18.22-19.22mm IP Complies
    Double Wall Thickness Cap :0.187-0.223mm Body:0.177-0.213mm IP Complies
    Empty Joining Length 23.5 ±0.3 mm IP Complies
    Remarks:
    1.The above batch complies with respect to IP 2014/IH specification.
    2.BSE/TSE Gelatin with preservatives and SLS.
    3.These are EAZY FIT design # Maintain the closed joining length
    between 21.1 - 21.9 mm .

    Prepared By Checked By Approved By


    QC Chemist QA Chemist Head QA

    Page 2 / 2

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