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    Product Specification: Carbopol 980 NF Polymer

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    tiroquim563
    This document provides product specifications for Carbopol 980 NF polymer, including its appearance, general characteristics, lot testing specifications, and testing procedures and frequencies. It specifies requirements for identification, carboxylic acid content, viscosity, clarity, residual solvents, benzene, and residual monomer. The information is intended to ensure product quality and consistency.

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    Product Specification: Carbopol 980 NF Polymer

    Uploaded by

    tiroquim563
    348 views1 page
    This document provides product specifications for Carbopol 980 NF polymer, including its appearance, general characteristics, lot testing specifications, and testing procedures and frequencies. It specifies requirements for identification, carboxylic acid content, viscosity, clarity, residual solvents, benzene, and residual monomer. The information is intended to ensure product quality and consistency.

    Original Description:

    ficha tecnica car 980

    Original Title

    Carbopol980 NF

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    This document provides product specifications for Carbopol 980 NF polymer, including its appearance, general characteristics, lot testing specifications, and testing procedures and frequencies. It specifies requirements for identification, carboxylic acid content, viscosity, clarity, residual solvents, benzene, and residual monomer. The information is intended to ensure product quality and consistency.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    348 views1 page

    Product Specification: Carbopol 980 NF Polymer

    Uploaded by

    tiroquim563
    This document provides product specifications for Carbopol 980 NF polymer, including its appearance, general characteristics, lot testing specifications, and testing procedures and frequencies. It specifies requirements for identification, carboxylic acid content, viscosity, clarity, residual solvents, benzene, and residual monomer. The information is intended to ensure product quality and consistency.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    of 1

    Product Specification

    CARBOPOL* 980 NF POLYMER


    Carbopol® 980 NF polymer meets the limits cited in the current edition of the following monographs:
    • United States Pharmacopeia/National Formulary (USP/NF) monograph for Carbomer Homopolymer Type C
    (Note: The previous USP/NF compendial name for this product was Carbomer 940.)
    • European Pharmacopeia (Ph. Eur.) monograph for Carbomers
    • India Pharmacopeia (IP) monograph for Carbomers
    • China Pharmacopeia (ChP) monograph for Carbomers
    General Product Characteristics
    Appearance: White, fluffy powder
    Odor: Slightly acetic
    Lot Test
    Test Specification Test Procedure2
    Frequency1
    Identification
    Colorimetric test Pass 1:200 USP/NF
    Gel formation test Pass 1:2003 USP/NF
    Infrared spectrum Pass ---4 Lubrizol SA-102
    Precipitate test Pass 1:200 USP/NF
    Carboxylic Acid Content, Assay % 56.0 - 68.0 1:1 Lubrizol 1318-A
    Viscosity, cP, 25°C
    Brookfield RVT, 20 rpm, neutralized to pH 7.3 - 7.8
    0.2 wt% mucilage, spindle #6 13,000 - 30,000 1:1 Lubrizol 430-I
    0.5 wt% mucilage, spindle #7 40,000 - 60,000 1:1 Lubrizol 430-I
    Clarity, % Transmission
    0.5% Dispersion, neutralized, 420 nm 85 min 1:1 Lubrizol 485-D
    Loss on Drying, % 2.0 max 1:1 USP/NF
    Heavy Metals, ppm
    Total heavy metals, as Pb 20 max 1:200 USP/NF
    Specific metals: Hg, Pb, As, Sb 10 max 1:200 Lubrizol SA-012
    Residual Solvent5
    Ethyl acetate, % 0.30 max 1:1 Lubrizol SA-009
    Cyclohexane, % 0.30 max 1:1 Lubrizol SA-009
    Benzene6
    Benzene, ppm 0.50 max 1:1 Lubrizol SA-064
    Residual Monomer, ppm
    Free acrylic acid 2,500 max 1:1 Lubrizol SA-005
    Sulphated Ash, % (Residue on ignition) 2.5 max 1:200 USP/NF
    1 Where lot test frequency is less than 1:1, Lubrizol Advanced Materials, Inc. certifies that each batch/lot meets requirements for the characteristics
    based on historical process and product data. Because these characteristics are tested on a skip-lot test frequency, results are not reported on the
    Certificate of Analysis.
    2 Lubrizol test procedures have been cross-validated to specified compendial procedure(s) or validated if they are included in the monograph.
    3 Gel formation is confirmed by the viscosity test procedure (Lubrizol 430-I) for each lot of polymer that is produced. Every 200 lots, the gel formation test
    is conducted according to USP requirements.
    4 Infrared reference spectra available upon request.
    5 No other residual solvents as listed in USP/NF <467> (Class 1, 2, 3, Table 4 or any other solvents) or Ph. Eur. 2.4.24 are used in the manufacturing
    process of this product.
    6 Benzene is tested due to it being a potential impurity.

    The information contained herein is believed to be reliable, but no representations, guarantees or warranties of any kind are made as to its accuracy, suitability for particular applications or the results to be obtained.
    The information often is based on laboratory work with small-scale equipment and does not necessarily indicate end product performance or reproducibility. Formulations presented may not have been tested for
    stability and should be used only as a suggested starting point. Because of the variations in methods, conditions and equipment used commercially in processing these materials, no warranties or guarantees are made
    as to the suitability of the products for the applications disclosed. Full-scale testing and end product performance are the responsibility of the user. Lubrizol Advanced Materials, Inc. shall not be liable for and the
    customer assumes all risk and liability for any use or handling of any material beyond Lubrizol Advanced Materials, Inc.’s direct control. The SELLER MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT
    NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Nothing contained herein is to be considered as permission, recommendation nor as an inducement to
    practice any patented invention without permission of the patent owner.
    Rev. 20180801
    Lubrizol Advanced Materials, Inc. / 9911 Brecksville Road, Cleveland, Ohio 44141-3247 / 216.447.5000

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