Carbomer Homopolymer Type B Safety. The carbomers manufactured using a benzene-free process are identif

The carbomers manufactured using a benzene-free process are identified as Carbomer Homopolymer, Carbomer Copolymer, and Carbomer Interpolymer. Formaldehyde 1 mg (0. ( 6 ) is the pharmaceutical grade of Carbomer-934. i n REVIEW ARTICLE INT RODU CTI ON A carbomer is a homopolymer of acrylic acid, whic h is cross-linked, or bonded, with any of s everal polyalcohol Health and safety, common uses, other names and ingredient information for Carbomer Homopolymer. 5% or more. 1%) is added as a preservative. inventi. What is the chemical formula of Carbomer? Jan 11, 2024 · According to the FDA, carbomers manufactured with benzene that are used in FDA-regulated drug products may fall under the United States Pharmacopeia-National Formulary (USP-NF) monographs Carbomer 934, Carbomer 934P, Carbomer 940, Carbomer 941, or Carbomer 1342. (7) The exact compositions of the Carbomer polymers are proprietary inf~rmation. Jul 15, 2024 · Cancer has been an enormous pain point for patients and regulatory bodies across the globe. Additionally, it may be desirable to substitute a benzene polymerized carbomer with a non-benzene polymerized carbomer in a pharmaceutical formulation. Carbopol homopolymers: acrylic acid crosslinked with allyl sucrose or allyl pentaerythritol Carbopol copolymers: acrylic acid and C10-C30 alkyl acrylate crosslinked with allyl pentaerythritol Carbopol interpolymers: carbomer homopolymer or copolymer that contains a block copolymer of polyethylene glycol and a long chain alkyl acid ester The carbomers manufactured using benzene are identified as Carbomer 934, Carbomer 934P, Carbomer 940, Carbomer 941, and Carbomer 1342. 4 days ago · The South Korea Carbomer Homopolymer Market is experiencing significant growth driven by technological innovations, increasing demand across various industries, and evolving regulatory frameworks. Carbomers are generally considered safe and well-tolerated when used as intended in cosmetic and pharmaceutical formulations. Dec 28, 2023 · To avoid confusion, and because of the safety concerns associated with these unacceptable levels of benzene permitted by these monographs, FDA has asked the USP to remove (or “omit”) the Carbomer 934P, Carbomer 940, Carbomer 934, Carbomer 1342, and Carbomer 941 monographs from the USP-NF compendium. The immediate implementation of the stoppage of finished products with Dec 8, 2025 · Synthalen® MP, USP grade carbomer homopolymer type B, is a benzene-free synthetic polymer used in the pharmaceutical industry as a thickener and suspending agent. These monographs allow benzene levels as high as 5,000 parts per million (ppm). The following table shows recommended alternatives for the benzene-grade Carbopol® polymer products based on viscosity criteria. Synthalen® MP dispersions are characterized by low viscosity at 0. Safety data sheet available for professional user on request. NM-Carbomer 934P is manufactured via a benzene-free process; whereas NM- Carbomer 974P uses a toxicologically preferred Class III solvent,which features lower toxicity and higher safety. − EC number (EINECS) : 618-347-7 − CAS number : 9003-01-4 − IUPAC name : 2-Propenoic acid, homopolymer − INCI name : Carbomer − Molecular formula : [C3H4O2]n − Molecular weight : Not applicable − REACH Registration Number : exempt from Registration Feb 6, 2024 · FDA issues guidance on reformulating drug products containing carbomers with benzene to address contamination concerns and ensure pharmaceutical safety. The Skin Deep® scoring system was designed to help the public understand whether a product is safe to use or whether it contains ingredients of concern. 2023, the US FDA released guidance on benzene-grade carbomer formulations, which triggered pharmaceutical manufacturers to assess risk, test finished products, and reformulate drug products with benzene-grade carbomer. Certain United States Pharmacopeia (USP) carbomer monographs currently allow for unacceptable levels of benzene, which raises safety concerns. To ensure that the requisite product viscosity is maintained throughout the shelf life and in-use period, the acceptance tests for (b) (4) Carbomer Homopolymer, NF (Type B) have been revised (b) (4) Nov 13, 2022 · What Is Carbomer? Carbomer is the commonly used name for an ingredient called polyacrylic acid (PAA). GSRS - National Institutes of Health GSRS. Cosmetics and personal care products are not required to be tested for safety before being allowed on the market. * Carbomer Homopolymer Type A: Carbopol® 71G NF, 971P NF and 981 NF Polymers Carbomer Homopolymer Type B: Carbopol® 974P NF and 5984 EP Polymers Carbomer Homopolymer Type C: Carbopol® 980 NF Polymers Compendial method or cross-validated house method Dec 12, 2024 · Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Retinyl Palmitate, Zea Mays (Corn) Oil, Cholecalciferol, Lanolin Alcohol, Fragrance, Methylparaben, Carbomer, Isopropyl Myristate, Isopropyl Stearate, Sodium Sulfite, Triethanolamine Know about technical details of Carbomer Homopolymer Type B like: chemical name, chemistry structure, formulation, uses, toxicity, action, side effects and more at Pharmacompass. Carbomer is a group of synthetic high molecular weight polymers of acrylic acid used in cosmetics and skincare products as thickening agents. (2) Carbomer-962 is the ammonium salt of Carbomer-941 and contains about 20% NH3. All Ingredients Benzyl Alcohol Carbomer Copolymer Type A Carbomer Homopolymer Type B Edetate Disodium Medium-Chain Triglycerides Mineral Oil Inactive Ingredients – Butylated hydroxytoluene, carbomer homopolymer type B, fractionated coconut oil, glycerin, glyceryl monostearate, isopropyl myristate, lanolin alcohols, mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. An assessment by the CIR Expert Panel Product name : CARBOMER HOMOPOLYMER Product Number Brand CAS-No. On January 1, 2006 the Carbomer Homopolymer monograph became effective in USP 29-NF 24. United States Pharmacopeia (USP) Monographs for Carbomers Carbomer-934 is reported to be a polymer of acrylic acid cross-linked with alkyl- sucrose: CH, = C H C H 2 - O - ~ ~ ~ r ~Carbomer-934P ~ e . : 1096281 : US Pharmacopeia : 151687-96-6 Health and safety, common uses, other names and ingredient information for Carbomer Homopolymer Type B. These compounds can absorb large amounts of water, increasing in volume up to 1,000 times to form gels and thick solutions that are stable and resistant to spoilage. com. On the basis of the available information presented and as qualified in the report, it is concluded that the Carbomer (Carbopol) products are safe as cosmetic ingredients. They are primarily added to gel-like formulations, such as facial moisturizers, sunscreens, shampoos, anti-aging formulations, cleansers, and Inactive ingredients carbomer homopolymer type B, colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate May 31, 2011 · In order to minimize this confusion, umbrella monographs have been developed to separate Carbomer products that are manufactured without the use of benzene as a polymerization solvent. Mar 27, 2025 · Carbomer is a high molecular weight polymer compound used commonly in the cosmetic industry. Dec 22, 2023 · The Cosmetic Ingredient Review (CIR) Expert Panel also stated that carbomers are safe to use for cosmetics according to their present use and concentration. Jan 1, 2016 · Publishe d on Web 16/11/2015, www. In Dec. ‘~) Carbomers-910 and -962 are two new − Description: high molecular weight cross-linked homopolymer of Acrylic Acid. 2% or less and high viscosity at concentrations of 0. Carbomer Homopolymer Type B USP NF Applicable synonyms for Carbopol® 974P NF polymer: Carbomer, carboxypolymethylene Polymerization/residual solvent: Ethyl acetate (ICH Class 3) Key Features: Suspension and emulsion stabilizer Taste masking agent Additional Features: Extended release agent Thickener/rheology modifier Bioadhesion agent Tablet Some common types of carbomer include carbomer 934, carbomer 940, and carbomer 980. Supplemental label information EUH210: Safety data sheet available on request.

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