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Product Grades Available - ashland.com

The regulatory compliance information for all Ashland products varies by Product family and grade. For specific data about the grade you are interested in please refer to our Excipient Information Packages or the Certificate of Analysis (CoA), which are Available from your Ashland sales hydroxypropylcellulose (HPC)Grade (X = Fine)Weight Average Molecular WeightTypical Brookfield Viscosity (mPa s)Solution Concentration (%)HF Pharm, HXF Pharm1,150,0001,500 3,0001MF Pharm, MXF Pharm850,0004,000 6,5002GF Pharm, GXF Pharm370,00015 0 4 0 02JF Pharm, JXF Pharm140,00015 0 4 0 05LF Pharm, LXF Pharm95,00075 15 05EF Pharm, EXF Pharm80,000300 60010 ELF Pharm40,00015 0 2 2510 Plasdone povidoneGradeaWeight Average Molecular WeightbK-Value ViscosityK-124, ,00016 . 0 17. 5K-2534,00024 26K-29/3258,00029 32K-901,300,00085 95C-124, ,00016.

The regulatory compliance information for all Ashland products varies by product family and grade. For specific data about the grade you are interested in …

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Transcription of Product Grades Available - ashland.com

1 The regulatory compliance information for all Ashland products varies by Product family and grade. For specific data about the grade you are interested in please refer to our Excipient Information Packages or the Certificate of Analysis (CoA), which are Available from your Ashland sales hydroxypropylcellulose (HPC)Grade (X = Fine)Weight Average Molecular WeightTypical Brookfield Viscosity (mPa s)Solution Concentration (%)HF Pharm, HXF Pharm1,150,0001,500 3,0001MF Pharm, MXF Pharm850,0004,000 6,5002GF Pharm, GXF Pharm370,00015 0 4 0 02JF Pharm, JXF Pharm140,00015 0 4 0 05LF Pharm, LXF Pharm95,00075 15 05EF Pharm, EXF Pharm80,000300 60010 ELF Pharm40,00015 0 2 2510 Plasdone povidoneGradeaWeight Average Molecular WeightbK-Value ViscosityK-124, ,00016 . 0 17. 5K-2534,00024 26K-29/3258,00029 32K-901,300,00085 95C-124, ,00016.

2 0 17. 5C-3058, C Grades have low pyrogen levels b Absolute molecular weight (SEC/MALLS)AquaSolve hypromellose acetate succinate (HPMCAS) GradeaWeight Average Molecular WeightNominal Viscosity (mPa s)bL114 , 7 0 , ,10 Available in fine and coarse particle sizes b NF/EP/JP viscosity method Product Grades AvailablePlasdone copovidoneGradeWeight Average Molecular WeightaK-Value ViscosityS-63047, molecular weight (SEC/MALLS)Polyplasdone crospovidoneGradeTypical Average Particle Size (Microns)Peroxide Specification (ppm)Ultra1110 14 030 MaxXL1110 14 0400 MaxUltra-10225 4050 MaxXL-10225 40400 Max1Ph. Eur. crospovidone monograph type A 2Ph. Eur. crospovidone monograph type BBenecel hypromellose (HPMC)Substitution TypeGradeWeight Average Molecular WeightSolution ConcentrationNominal Viscosity (mPa s)aHypromellose 2910 E typesE4M Pharm1400,0002%2,700 5,040E10M Pharm1746,0002%7,500 14,000 Hypromellose 2208 K typesK100LV PH PRM2164,0002%8 0 120K250 PH PRM2200,0002%200 300K750 PH PRM2250,0002%562 1050K1500 PH PRM2300,0002%1,125 2,10 0K4M Pharm1400,0002%2,700 5,040K15M Pharm1575,0002%13,500 25,200K35M Pharm1675,0002%26,250 49,000K100M Pharm11,000,0002%75,000 140,000K200M Pharm11,200,0002%150,000 280,000aNF/EP/JP viscosity method 1CR Grades Available 2 Only CR Grades availableBenecel directly compressible hypromellose (HPMC)

3 Substitution TypeGradeWeight Average Molecular WeightSolution ConcentrationNominal Viscosity (mPa s)aHypromellose 2208 K typesK4M PH DC1400,0002%2,700 5,040K15M PH DC1575,0002%13,500 25,200K100M PH DC11,000,0002%75,000 140,0001 These Grades are co-processed with silica at <1 wt%Benecel methylcellulose (MC) and methylhydroxyethylcellulose (MHEC)Substitution TypeGradeNominal Viscosity (mPa s)aMethylcelluloseA15 LV PH PRM12 18A4C Pharm300 560A15C Pharm1,312 2,450A4M Pharm2,700 5,040 MethylhydroxyethylcelluloseME 233 P Pharm3,100 5,700aNF/EP/JP viscosity method 1CR Grades Available 2 Only CR Grades availableAquarius film coating systemsGradeDescriptorDetailClassPreferr edHSCHigh-solids coatings based on cellulosic polymers AestheticPreferredHSPHigh-solids coatings based on copovidone with cellulosic polymers for significant improvements in adhesion and sprayable solidsPrime - Coatings based on traditional cellulosic polymersPrimeLSCoatings based on lactoseProtect-Label-friendly moisture, odor and taste guardFunctionalControlENAD elayed-release (enteric)

4 Coatings based on methacrylic acid-ethyl acrylate copolymerControlSRXS ustained release coatings based on ethylcellulose Aqualon sodium carboxymethylcellulose (CMC)Weight Average Molecular WeightViscosity (mPa s)Solution ConcentrationDegree of ,0001,500 3,0001%7HF PH725,0001,000 2,8001%7H3SF PH725,0001,000 2,8001%7 HOF PH395,0001,500 3,1002%9M31F PH395,000800 3,1002%12M31P250,000400 8002%7MF PH250,000400 8002%7M8SF PH250,000400 8002%9M8F PH90,50025 502%7LF PH49,00050 2004%7L2 PBlanose sodium carboxymethylcellulose (CMC)Weight Average Molecular WeightViscosity (mPa s)Solution ConcentrationDegree of ,0002,500 4,5001%7H4XF PH9H4XF PH725,0001,500 2,5001%7HF PH725,0001,000 2,8001%7H3SF PH725,0001,000 2,8001%7 HOF PH395,0001,500 3,1002%7M31F PH9M31F PH12M31P395,000200 8002%7M8SF PH395,0001,2 0 0 1,8 0 02%9M20F PH395,000400-8002%12M8 P250,000400 6002%7MF PH250,00050 1002%7M1F PH90,50025 502%7LP EPAqualon ethylcellulose (EC)Grade Ethoxyl Substitution (%)Weight Average Molecular WeightTypical Brookfield Viscosity (mPa s)1 Solution Concentration (%)T10 Pharm4 9.

5 6 51. 075,0008 115N7 ,0006 85N10 ,0008 115N14 ,00012 165N22 ,00018 245N50 ,00040 525N100 ,00080 10551 Viscosity measured in 80:20 mixture of toluene/ethanolNatrosol hydroxyethylcellulose (HEC)Grade (X = Fine, W = Superfine)Weight Average Molecular WeightTypical Brookfield Viscosity (mPa s)Solution ConcentrationHHX Pharm, HHW Pharm1,300,0003,500 5,5001%HX Pharm, H Pharm1,000,0001,500 2,5001%M Pharm720,0004,500 6,5002%G Pharm300,000250 4002%L Pharm90,00075 15 05%Hydroxypropyl- - and hydroxypropyl- -cyclodextrinsProduct and GradeWeight Average Molecular WeightTypical Degree of SubstitutionCAVA SO L* W7 HP Pharma1, W7 HP5 Pharma1, W7 HP7 Pharma1,52 SO L* W8 HP Pharma1, 5 *Registered trademark owned by Wacker Chemie AG. Ashland acts as a worldwide distributor for cyclodextrinProduct and GradeWeight Average Molecular WeightCyclodextrin TypeCAVA M A X* W6 Pharma973 -cyclodextrinCAVA M A X* W7 Pharma1,13 5 -cyclodextrinCAVA M A X* W8 Pharma1,297 -cyclodextrin*Registered trademark owned by Wacker Chemie AG.

6 Ashland acts as a worldwide distributor for N-methyl-2-pyrrolidone (NMP)Pharmasolve NMP is a liquid used for crystal inhibition and solubility enhancement in parenteral applications and in veterinary medicine. Its viscosity is CENTERSE urope Switzerland Tel: +41 52 560 55 00 India MaharashtraTel: +91 22 61489696 Asia Pacific Singapore Tel: +65 6775 5366 Middle East, Africa Dubai, : +971 4 3818515 Latin America Mexico Tel: +52 55 52 76 Registered trademark, Ashland or its subsidiaries, registered in various countries T rademark, Ashland or its subsidiaries, registered in various countries 2016, Ashland / information contained in this brochure and the various products described are intended for use only by persons having technical skill and at their own discretion and risk after they have performed necessary technical investigations, tests and evaluations of the products and their uses.

7 Certain end uses of these products may be regulated pursuant to rules or regulations governing medical devices, drug uses, or pesticidal or antimicrobial uses. It is the end user s responsibility to determine the applicability of such regulations to its statements, information, and data presented herein are believed to be accurate and reliable, but are not to be taken as a guarantee of fitness for a particular purpose, or representation, express or implied, for which seller assumes legal responsibility. No freedom to use any patent owned by Ashland, its subsidiaries, or its suppliers is to be inferred.


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