UNTREATED FUMED SILICA CAB-O-SIL M-5P - Sanmar Group

1 UNTREATED FUMED SILICACAB-O-SIL M-5 PCabot Sanmar LimitedCabot Sanmar Limited is the only manufacturer of FUMED silicain India, a Joint Venture with cabot corporation , M-5P UNTREATED FUMED SILICA (pharmaceutical grade) isa high purity, chemically inert, odourless, white, free flowing powdermanufactured using state-of-the-art technology through a continuousprocess involving flame hydrolysis of silicon tetrachloride in an oxy-hydrogen + 2H2 + O2 SiO2 + 4 HClCAB-O-SIL M-5P FUMED SILICA is hydrophilic due to the presence ofsurface hydroxyl groups. It has X-ray amorphous structure due torapid cooling of the SILICA particles from the molten state to the solidstate during manufacturing. It has a refractive index of as aresult of which it disappears completely in organic solvents havingrefractive index close to the manufacturing process, silicon dioxide moleculescondense to form particles.

2 The particles collide, attach and sintertogether resulting in three-dimensional branched chain aggregatesof approximately 150 to 200 nanometers in length. Once theaggregates cool below the fusion point of SILICA (1710 C), furthercollisions result in mechanical entanglement of the chains, termedas SILICA is a well-known pharmaceutical excipient since 1957 as Traditional glidant for solid dosage form Suitable for soft powder mixtures Thickener for pharmaceutical oilsThe basic manufacturing process for pharma and non-pharma gradesof CAB-O-SIL UNTREATED FUMED SILICA product are almost , in response to our pharma customers need, as a part ofour commitment to the pharmaceutical industry, we manufacturethe pharmaceutical grade FUMED SILICA CAB-O-SIL M-5P, withprocess control under steady state conditions and goodmanufacturing practices in our ISO 9001, ISO 14001 and BS OHSAS18001 certified manufacturing facility.

3 The product undergoes 1800 Crigorous quality tests using all major pharmacopoeia test methodsand is supported by complete documentation prior to release forsales. All tests performed are included in Certificate of properties comply with recent version of pharmacopoeiamonographs and registered with USFDA for type-IV Status - PharmaceuticalsUSP/NColloidal Silicon DioxidePh. , Colloidal AnhydrousJPLight Anhydrous Silicic AcidType IV DMF25597 COA test ParametersBET Surface Area1 Identification2, 3, 4 Tapped Density1pH 2, 3325 mesh residue1 Chloride3, 4 Arsenic2, 4 Heavy Metals3, 4 Loss on Drying2, 4 Loss on Ignition2, 3, 4 Assay (SiO2 content) 2,3, 4 Aluminum4 Calcium4 Iron4 Volume Test41 Cabot Test Method2 USP/NF Monographs3 Ph. Eur.

4 Monographs4 JP MonographsTypical properties of CAB-O-SIL M-5P ProductParameterTypical ValuesBET Surface Area, m2/g200 Tapped Density, g/LCa 40pH, 4% aqueous dispersionCa on Drying, 105 C, 2hr< %Loss on Ignition, Dried< %material, 1000 C, 2hrSiO2 Content, by weight> %Scanning electron micrograph of CAB-O-SIL M-5 PCAB-O-SIL M-5P for Pharma applicationsIn Solid dosage form (tablets & capsules) Improved powder flow and packing characteristics Reduces caking Improve tablet properties Hardness Weight uniformity Content uniformity Increased tensile strength Enhanced dissolution Improved tabletting operationIn Semi-solid dosage form (suppositories & transdermal) acts as Inorganic thickener Viscosity enhancer Keeps the active ingredientuniformly distributedIn Liquid dosage form (gels,cream, suspensions) Thickens low polarity media Forms clear gel Helps pseudo plastic flow behaviour Keeps the particles in suspension Prevents sedimentationHygroscopicityCAB-O-SIL M-5P FUMED silicaparticles are non-porous and typicallythe moisture content is less than 1%at the time of packaging, which can beremoved by heating at 110 particle size and large number ofsurface hydroxyl Group makes the M-5P FUMED SILICA an excellentdesiccant.

5 It absorbs moisture but will not liquefy, which helps tostabilize moisture sensitive ingredients in drugs, tablets andcapsules preventing agglomeration of powder PropertiesM-5P FUMED SILICA is used as glidant and anti-caking agent toimprove the flow properties of granulation in high-speed tabletand capsule machine. Particulate flow has a direct effect on weightuniformity and plays an important role in solid-solid blendingand powder homogeneity. Reduces friction between particles Improves flow of granulations Improves fill of surface irregularities in granules Prevents segregation and separation of granules Assists in prevention of cavitations or surging of tabletgranulation in a powder Status FoodCAB-O-SIL M-5P FUMED SILICA has been approved for use as foodadditives as per EU Directive 2000/63/EC for food additive E 551 21 CFR (Code of Federal Regulations), silicon dioxide may be safely used as an anti-caking agent with an upperlimit not to exceed 2%.

6 Silicon dioxide may be used as astabilizer in beer production (if removed later by filtration), andas an adsorbent for di-a-tocopheryl acetate and panthenalalcohol in tabletted dietary M-5P FUMED SILICA has been approved for use as foodcontact substance. According to EU Directive 2002/72/EC, silicon dioxide islisted for food contact use in Annex Ill, Section A withreference number 86240. In Appendix 2 of the Council ofEurope Resolution AP (96) 5, silicon dioxide is listed in List1, Part 2, under Additives (substances classified in SCFlists 0 to 4) with the reference number 86240. According to 21 CFR parts 174-178, silicon dioxide maybe used as given directly or indirectly by reference to 21 CFR ContaminationCAB-O-SIL M-5P FUMED SILICA productsare sterile immediately aftermanufacture because of the hightemperature production and storage of thepharmaceutical grades are performedin accordance with good M-5P FUMED SILICA is aninert inorganic material and is not asource of microbial nutrition.

7 At the timeof packaging the moisture content isless than 1% and both gram-negativeand gram positive bacteria cannotsurvive for more than a few hours todays depending on the type of possible survival of somesporogenic microorganisms cannot be completely ruled out evenunder these testing is performed on random samples at regularintervals. We, and our partners along the distribution chain, do ourutmost to ensure that CAB-O-SIL M-5P product reaches ourcustomers without any contamination. However, contamination isstill possible during shipping and storage so we recommendcustomers to perform microbiological checks on the product beforeusing , Allergens & TSE-BSE complianceNo materials from plant or animal origin are used during the manufacturing,packaging and storage of CAB-O-SIL M-5P FUMED SILICA .

8 The productionand packaging processes for CAB-O-SIL M-5P FUMED SILICA productsare closed and as such there is no risk of genetically modified organismand any plant or animal derived allergens or precursors of disease (BSE,TSE etc.).Residual SolventsNo organic solvents are used orformed as by-product during themanufacturing of CAB-O-SIL FUMED SILICA and StorageCAB-O-SIL M-5P FUMED silicais packed and shipped in a3-ply 10kg Kraft paper bags withan outer LDPE SILICA being achemically inert stable metaloxide it could be theoreticallystored for many years withoutany change in its , due to its high specificsurface area, there could beadsorption of volatilesubstances, moisture or other chemical vapours from theenvironment onto its surface.

9 Also proper storage is critical to preventexternal contamination and damage of the bags. We recommendthat CAB-O-SIL M-5P product should be stored in a clean, dry areaaway from heat, moisture and chemical vapours at ambientconditions. Do not store together with volatile chemicals as theymay adsorb onto the product. It should be consumed within twoyears from its date of proper equipment CAB-O-SIL M-5P product can be handled almostcompletely dust-free. For more information on these services, pleasecontact our representatives in your M-5P product is an inert and non-toxic material. However, werecommend certain precautions, although not required, they improve thecomfort level of persons working with it. Ventilated work area - In the laboratory, working with CAB-O-SIL M-5P product in a powder handling booth is ventilation is not available, a dust respirator isrecommended.

10 Avoid continued excessive inhalation by using personalprotective equipment. Wear appropriate eye protection. Wash hands after handling CAB-O-SIL M-5P product asthe product may leave a dry feeling of the skin. Use ofprotective skin cream and/or gloves is recommended whilehandling CAB-O-SIL M-5P products Follow the Product Safety Data Sheet for information relevantto maximum work area concentrations and other safetyaspects of the FUMED SILICA products. In addition, for safety reasons it should be noted that CAB-O-SIL M-5P product can build up static electrical chargeswhen subjected to friction during conveyance and/or handling near flammable or explosive liquids, be sureto take proper safety precautions, such as electricalgrounding, inert atmosphere, Safety Data SheetsMaterial Safety Data Sheets (also known as MSDS) for CAB-O-SIL M-5P FUMED SILICA available on Office & South Zone9 Cathedral RoadChennai 600 086 Tamil Nadu INDIATel: +91 44 2812 8500 Fax: +91 44 2811 4116E-mail: & East ZoneM2 Third FloorSouth Extension Part-IINew Delhi 110 049 INDIATel: +91 11 4259 7999 Fax.