Excipients - Food Colors - Binders and Tableting Aids

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Product name
CAS
Formula

Microcrystalline Cellulose

CAS9004-34-7
FormulaC6H10O5
SynonymMCC
Heavy Metals10 PPM Max.
Residue on Ignition0.05% Max.
Escherichia coliNegative
AppearanceOff-White
Total molds & yeasts<10 cfu/g
IdentificationDP 350 Max. (Test C)
Ether-soluble substances0.05% Max.
IdentificationConforms (Tests A, B)
Water-soluble Substances0.24% Max.
Conductivity75 Max.
Staphylococcus aureusNegative
pH5.0 - 7.0
Salmonella speciesNegative
Pseudomonas aeruginosaNegative
Loss on Drying5.0% Max.
Organic Volatile ImpuritiesWithin limits
Total Aerobic Microbial<100 cfu/g

Stearic Acid (Powder/Beads/Flakes)

CAS57-11-4
FormulaC18H36O2
SynonymOctadecanoic acid
Acid Value205 - 211 mg KOH/g
Iodine Value0.50 g I2/100g max.
Melting Point54 - 57&degC
Saponifiable Value206 - 212 mg KOH/g
Color Lovibond 5 1/40.2R / 2.0Y max.
Fatty Acid ProfileC14: 2.0% max., C16: 52 - 56%, C18:0: 42 - 47%, C18:1: 0.5% max., Others: 1.0% max.

Hydroxy Ethyl Cellulose

CAS9004-62-0
FormulaN/A
SynonymHEC, Cellulose, hydroxyethyl ether, Cellulose, 2-hydroxyethyl ether, Cellulose, 2-hydroxyethyl ether
pH6.0-8.5 (1)
Insolubilityin org. solvs.
Melting Point288-290 c (dec.)
Odorwh. free-flowing powd., odorless, tasteless
Refractive Index1.336
Solubilityhot or cold water

Stearic Acid

CAS57-11-4
FormulaC18H36O2
SynonymOctadecanoic acid
Iodine Value< 1.5
Titer65 - 69 C
C18:090.0 - 100.0%
C18:1< 2.0%
C16:0< 10.0%
Saponification Value196 - 202
Color, % Trans. 440/550> 35/40%
Acid Value195 - 201

Ethoxylated Stearyl Alcohols 20

CAS9005-00-9
FormulaC6H3Cl4N
Synonym6-Tetrachloro-2-picoline, Poly(oxy-1,2-ethanediyl), .alpha.-octadecyl-.omega.-hydroxy-
Appearance @ 25CSolid
Acid Value, mg KOH/g1.0 Max.
Solubility5% Aqueous @ 25 deg C - Soluble
Melting Point39 deg C
Moisture, %1 % Max.
Hydroxyl Value mg KOH/gram45 - 60
HLB14.6
pH of 5% aqueous solution7
Iodine Value, cg Iodine/gram0.5
Flash Point COC °C> 175 deg C

Ethoxylated Stearyl Alcohols 2

CAS9005-00-9
FormulaC6H3Cl4N
Synonyma,a,a,6-Tetrachloro-2-picoline, Poly(oxy-1,2-ethanediyl), .alpha.-octadecyl-.omega.-hydroxy-
Moisture, %0.8 % Max.
Iodine Value, cg Iodine/gram0.5
HLB9.5
Flash Point COC °C> 175 deg C
Appearance @ 25CSolid
Melting Point43 deg C
Hydroxyl Value mg KOH/gram155-162
Solubility5% Aqueous @ 25 deg C - Insoluble
pH of 5% aqueous solution7
Acid Value, mg KOH/g0.5 Max.

Hydroxypropyl Methylcellulose F4M USP

CAS9004-65-3
SynonymHPMC, Cellulose, 2-hydroxypropyl methyl ether, Cellulose, 2-hydroxypropyl methyl ether
Residue on Ignition1.5% max.
Arsenic3 ppm max.
Total Bacteria1000/gram max.
Particle Size90% min. through 40 mesh
AppearanceWhite to slightly off white free flowing powder
Heavy Metals10 ppm max.
Organic Volatile ImpuritiesTo meet the requirements
Methoxyl Content27.0 - 30.0%
Loss on Drying5.0% max.
Hydroxypropyl Content4.0 - 7.5%
pH5.5 - 8.0
Mold100/gram max.
Apparent Viscosity3500 - 5600 cps

Croscarmellose Sodium

CAS74811-65-7
SynonymSodium Carboxymethylcellulose, Sodium CMC
Contents of water soluble materials (%)1.0 - 10.0
Identification A, B, CConforms
Degree of substitution0.60 - 0.85
Settling volume (ml)10 - 30
pH (1%)5.0 - 7.0
Heavy metals (ppm)<10
Loss on drying (%)<10.0
Organic Volatile ImpuritiesWithin limit
ColorWhite or off white
AppearanceFree-flowing, fibrous powder
Sodium chloride and sodium glycolate (%)<0.5

Lactose

CAS63-42-3
FormulaC12H22O11
Synonym1-beta-D-Galactopyranosyl-4-alpha-D-glucopyranose, d-Glucose, 4-O-.beta.-D-Galactopyranosyl, D-Glucose, 4-O-.beta.-D-galactopyranosyl-, Lactose
Density1.525 (20 c)
Slightly Solublein alcohol
Protein0.1 %
ColiformNegative
Moisture99.5 %
Ash0.15 %
ColorLight Cream to White
SalmonellaNegative
Loss on Drying0.1 %
AppearanceCrystalline Powder
E. ColiNegative
Standard Plate Count< 100 CFU/g
Odorwh. hard cryst. mass or wh. powd., odorless to sl. char. odor but readily absorbs odors, mildly swee
Melting Point203.5 c (dec.)
Molecular weight342.34
Solubilitywater, alcohol, ether
Boiling Point(dec.)

FD&C Green #3

CAS2353-45-9
SynonymC1 Food Green 3, Cl 42053, Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, inner salt, sodium salt (1:2), Dihydrogen(ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclo
AppearanceBurgundy powder, free of foreign matter
ColorTo match standard
OdorOdorless
Pure Dyenot more than 85%
Insolubles (in HCL)not more than %
Leadnot more than 10 ppm
Arsenicnot more than 3 ppm
Mercurynot more than 1 ppm
Melting Point290 c (dec.)
Molecular weight810.91
Solubilitywater, conc. sulfuric acid, ethanol

FD&C Yellow #6 Lake

CAS2783-94-0
SynonymSunset Yellow FCF, Cl 15985:1, 2-Naphthalenesulfonic acid, 6-hydroxy-5-[2-(4-sulfophenyl)diazenyl]-, sodium salt (1:2), Disodium6-hydroxy-5-[(4-sulphonatophenyl)azo]naphth alene-2-sulphonate
Slightly Solublein abs. alcohol
AppearanceOrange powder, free of foreign matter
ColorTo match standard
OdorOdorless
Pure Dye17.0% - 19.0%
Insolubles (in HCL)not more than 0.5%
Leadnot more than 20 ppm
Arsenicnot more than 3 ppm
Mercurynot more than 1 ppm
Melting Point300 c (dec.)
Solubilityconc. sulfuric acid

FD&C Yellow #5 Alum Lake

CAS12225-21-7
SynonymFood Yellow 4, Cl 19140:1, C.I. Pigment Yellow 100, Aluminium5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophe nylazo)-1H-pyrazole-3-carboxylate (CI19140:1)
AppearanceYellow powder, free of foreign matter
ColorTo match standard
OdorOdorless
Pure Dye8.0% - 10.0%
Insolubles (in HCL)not more than 0.5%
Leadnot more than 10 ppm
Mercurynot more than 1 ppm
Arsenicnot more than 3 ppm

FD&C Red #40 Alum Lake 35-42%

CAS68583-95-9
SynonymC.I. Food Red 17:1
DescriptionA red, water insoluble pigment
Pure DyeNot less than 35%. Range 35-42%
IdentificationCompares favorably to accepted standard

FD&C Yellow #5 Alum Lake 14-16%

CAS12225-21-7
SynonymC.I. Pigment Yellow 100, Aluminium5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophe nylazo)-1H-pyrazole-3-carboxylate (CI19140:1)
DescriptionA yellow, water insoluble pigment
Pure DyeNot less than 14%. Range 14-16%
IdentificationCompares favorably to accepted standard

FD&C Yellow #6 Alum Lake 35-42%

CAS15790-07-5
SynonymC.I. Pigment Yellow 104
DescriptionAn orange, water insoluble pigment
Pure DyeNot less than 35%. Range 35-42%
IdentificationCompares favorably to accepted standard

FD&C Yellow #5 Alum Lake 35-42%

CAS12225-21-7
SynonymC.I. Pigment Yellow 100, Aluminium5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophe nylazo)-1H-pyrazole-3-carboxylate (CI19140:1)
DescriptionA yellow, water insoluble pigment
Pure DyeNot less than 35%. Range 35-42%
IdentificationCompares favorably to accepted standard

FD&C Blue #2 Alum Lake 12-14%

CAS16521-38-3
SynonymC.I. Pigment Blue 63, 2-(1,3-Dihydro-3-oxo-5-sulfo-2H-indol-2-yliden e)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid aluminium complex (CI 73015)
DescriptionA bright blue, water insoluble pigment
Pure DyeNot less than 12%. Range 12-14%
IdentificationCompares favorably to accepted standard

FD&C Red #40 Alum Lake 14-16%

CAS68583-95-9
SynonymC.I. Food Red 17:1
DescriptionA red, water insoluble pigment
Pure DyeNot less than 14%. Range 14-16%
IdentificationCompares favorably to accepted standard

Sodium Carboxymethylcellulose, FCC

CAS9004-32-4
FormulaC6H9OCH2COONa
SynonymCroscarmellose Sodium, Cellulose, carboxymethyl ether, sodium salt, Cellulose, carboxymethyl ether, sodium salt
Assay99.5% - 99.9%
Moisture10% Max
pH6.0 - 8.5
Bulking Value in Solution0.0652 gal/lb
D.S.0.65-0.95
Sodium6.5% - 9.5%
pH of solution7.5
Viscocity1,400 - 3,000 cP (1%)
Mesh65% Thru USS #140
Standard Plate Count50,000/g maximum
Yeast & Molds500/g maximum
Total Coliforms<30/g maximum
E.ColiNegative
SalmonellaNegative
StaphylococcusNegative

Methylcellulose, A4M Food Grade

CAS9004-67-5
SynonymMC, Cellulose, methyl ether, Cellulose, methyl ether
Apparent Viscosity, cp3500-5600
Loss on Drying5.0max
Heavy Metals10 max
pH @ 25 °C5.5-8.0
Methoxyl Content28.0-32.0
Mold100/gram max
Residue on Ignition1.5 max
Arsenic PPM3.0 max
Total Bacteria1000/gram max
Particle Size95% min through 40 mesh
AppearanceWhite powder
Organic Volatile ImpuritiesMeets the requrements
Insolubilityin alcohol, ether, chloroform, warm water
Odorgrayish-wh. fibrous powd., odorless, tasteless
Molecular weight86,000-115,000
Solubilitycold water, glacial acetic acid, some org. solvs.

Hydroxypropyl Methylcellulose, K100M USP Grade

CAS9004-65-3
SynonymHPMC, Cellulose, 2-hydroxypropyl methyl ether, Cellulose, 2-hydroxypropyl methyl ether
AppearanceWhite free-flowing powder
Hydroxypropyl Content7.0-12.0
Loss on Drying5.0max
Total Bacteria1000/gram max
Arsenic PPM1.5 max
Apparent Viscosity, cp80000-120000
pH @ 25 °C5.0-8.0
Particle Size95% min through 40 mesh
Organic Volatile ImpuritiesMeets the requrements
Methoxyl Content19.0-24.0
Residue on Ignition1.5 max
Mold100/gram max
Heavy Metals10 max

Hydroxypropyl Methyl Cellulose 50FG

CAS9004-65-3
SynonymHypromellose USP, Cellulose, 2-hydroxypropyl methyl ether, Cellulose, 2-hydroxypropyl methyl ether
Loss on DryingNMT 5.0%
Methoxyl28.0-30.0
Arsenic PPMNMT 2PPM
pH5.5-8.0
ChloridesNMT 0.5%
Sulfated AshNMT 1.5%
HydroxyPropoxy7.0-12.0
SensoricAmber Solution
Heavy Metals; USP <231>NMT 10PPM
Viscocity50cP
Apparent Viscosity40.0-60.0

Hydroxypropyl Methyl Cellulose 5FG

CAS9004-65-3
SynonymHypromellose, USP, Cellulose, 2-hydroxypropyl methyl ether, Cellulose, 2-hydroxypropyl methyl ether
Heavy Metals; USP <231>NMT 10 PPM
ChloridesNMT 0.5%
Sulfated AshNMT 1.5%
SensoricAmber Solution
Arsenic PPMNMT 2 PPM
Methoxyl Content28.0-30.0
Apparent Viscosity4.0-6.0
Loss on DryingNMT 5.0%
HydroxyPropoxy7.0-12.0
pH5.5-8.0
Viscocity5cP

Hydroxypropyl Methyl Cellulose 15 FG

CAS9004-65-3
SynonymHypromellose, USP, Cellulose, 2-hydroxypropyl methyl ether, Cellulose, 2-hydroxypropyl methyl ether
HydroxyPropoxy7.0-12.0
Loss on DryingNMT 5.0%
Heavy Metals; USP <231>NMT 10PPM
AppearanceAmber Solution
Methoxyl28.0-30.0
Arsenic PPMNMT 2 PPM
Viscocity15cP
Apparent Viscosity12.0-18.0
pH5.5-8.0
ChloridesNMT 0.5%
Sulfated AshNMT 1.5%

Hydroxypropyl Methyl Cellulose 3 FG

CAS9004-65-3
SynonymHypromellose, USP, Cellulose, 2-hydroxypropyl methyl ether, Cellulose, 2-hydroxypropyl methyl ether
Methoxyl Content28.0-30.0
Loss on Dryingnmt 5.0%
Arsenic PPMnmt 2PPM
HydroxyPropoxy Content7.0-12.0
Sulfated Ashnmt 1.5%
SensoricAmber solution
Heavy Metals; USP <231>nmt 10 ppm
Apparent Viscosity2.4-3.6
Viscocity3cP
pH5.5-8.0
Chloridesnmt .5%
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