TABLE X

Excipients Listed in the FDA Inactive Ingredient Guide*

ExcipientRoute/Dosage FormConcentration
1,2-dimyristoyl-sn-glycero-3-(phospho-s-(1-glycerol)IV (infusion); suspension, injection0.15
1,2-Dioleoyl-sn-glycero-3-phosphocholineEpidural; injection, suspension, liposomal0.42
1,2-Dipalmitoyl-sn-glycero-3-(phospho-rac-(1-glycerol)Epidural; injection, suspension, liposomal0.09
1,2-Distearoyl-sn-glycero-3-(phospho-rac-(1-glycerol)Intravenous; injection, powder, lyophilized, for liposomal suspension8.4
1,2-Distearoyl-sn-glycero-3-phosphocholineIntravenous; solution, liposome, injection2.8
1-Methyl-2-pyrrolidinoneSubcutaneous; injection25.85
Acetic acidIntravenous; injection12.75
Acetic anhydrideIntravenous; injection
Acetone sodium bisulfiteAN,CNBLK intrathecal; injection
Acetylated monoglyceridesIntravenous; injection
AcetyltryptophanIntravenous; injection0.02
Activated charcoalIntramuscular; injectable0.3
Adipic acidIntramuscular; injection1
AlanineIV (infusion); injection77
Albumin aggregatedIntravenous; injection0.15
Albumin colloidalIntravenous; powder, for injection solution0.1
Albumin humanIV (infusion); powder, for injection solution, lyophilized80
Albumin microshere human serumIntravenous; injection0.5
AlcoholIntravenous; injection49
Alcohol, dehydratedIV (infusion); injection80
Alcohol, denaturedIntravenous; injection
Alcohol, dilutedIM–IV; injection10
AlfadexIntracavitary; powder, for injection solution, lyophilized0.12
Alpha-tocopherol, DL-Intravenous; solution, concentrate0.07
Ammonium acetateIntramuscular; injection0.8
Ammonium hydroxideIntravenous; injection0.21
Ammonium sulfateIntravenous; injection, suspension, liposomal0.2
Anhydrous citric acidIntravenous; powder, for injection solution, lyophilized42.18
Anhydrous lactoseIntravenous; powder, for injection solution, lyophilized28.75
ArginineIV (infusion); injection88
Ascorbic acidIntravenous; injection62.5
Aspartic acidIV (infusion); injection0.68
Benzalkonium chlorideIntramuscular; injection
Benzenesulfonic acidIntravenous; injection
Benzenesulfonic acidIV (infusion); injection
Benzethonium chlorideIntravenous; powder, for injection solution0.05
Benzoic acidIM–IV; injection5
Benzyl alcoholIntramuscular; injection10.96
Benzyl benzoateIntramuscular; injection46
Benzyl chlorideIntravenous; injection1.00E-03
BibapcitideIntravenous; injection0.01
Boric acidIntravenous; solution, injection0.31
BrocrinatIV (infusion); injection
Butylated hydroxyanisoleIntramuscular; injection0.03
Butylated hydroxytolueneIntramuscular; injection0.03
Butylated hydroxytolueneIntravenous; powder, for injection solution, lyophilized1.50E-03
ButylparabenIntramuscular; injection
CalciumIntramuscular; injection1.20E-03
Calcium chlorideIM–IV; injection4
Calcium gluceptateIntravenous; injection5
Calcium hydroxideIntravenous; injection0.37
Caldiamide sodiumIntravenous; solution, injection1.2
Calteridol calciumIntravenous; injection0.02
CaptisolIntravenous; injection67.5
Carbon dioxideIM–IV; injection
CarboxymethylcelluloseIntramuscular; injection0.9
Carboxymethylcellulose sodiumIntramuscular; injection3
Castor oilIntramuscular; injection
Cellulose, microcrystallineIntravenous; injection14.9
ChlorobutanolIV (infusion); injection0.6
Chlorobutanol hemihydrateIntramuscular; injection0.52
Chlorobutanol, anhydrousIntramuscular; injection0.52
CholesterolIntravenous; solution, liposome, injection0.68
CitrateIntravenous; injectable0.72
Citric acidIntravenous; injectable41.36
Citric acid monohydrateIntravenous; injection52.5
Citric acid, hydrousIntravenous; injection10.5
Corn oilIntramuscular; injection
Cottonseed oilIntramuscular; injection87.46
CreatineIntramuscular; injection
CreatinineIM–IV; injection0.8
CresolSubcutaneous; injection
Croscarmellose sodiumIntramuscular; injection1
CrospovidoneIntramuscular; injection0.02
CysteineIntravenous; powder, for injection solution, lyophilized2.6
Cysteine hydrochlorideIV (infusion); injection2
Cysteine hydrochloride, anhydrousIntradiscal; powder, for injection solution
Deoxycholic acidIV (infusion); powder, for injection solution
DextranIntravenous; liquid, concentrate, injection
Dextran 40Intravenous; powder, for injection solution, lyophilized30
DextroseIntravenous; injection30
Dextrose monohydrateIntravenous; solution, injection5
Dextrose solutionIV (infusion); powder, for injection solution5
Dextrose, anhydrousSpinal; injection8.25
Diatrizoic acidIntramuscular; injection59.7
DiethanolamineIV (infusion); injection1.5
Dimethicone 360Intravenous; injectable
Dimethyl sulfoxideIV (infusion); powder, for injection suspension, lyophilized
Dimyristoyl lecithinIntravenous; powder, for injection solution, lyophilized7.05
Disodium sulfosalicylateIV (infusion); powder, for injection solution, lyophilized0.03
DisofeninIV (infusion); injection2
Docusate sodiumIntramuscular; injection0.01
Edetate calcium disodiumIntravenous; injection0.48
Edetate disodiumIntravenous; injection10
Edetate disodium anhydrousIntravenous; injection0.02
Edetate sodiumIV (infusion); solution, injection0.04
Edetic acidSubmucosal; solution, injection0.05
Egg phospholipidsIV (infusion); injection1.8
Ethanolamine hydrochlorideIntravenous; injection0.15
Ethyl acetateIntramuscular; injection
EthylenediamineIV (infusion); injection0.39
ExametazimeIntravenous; injection
FampridineIntravenous; injection
Ferric chlorideIntravenous; injection6.05
FructoseIV (infusion); powder, for injection solution, lyophilized5
Gadolinium oxideIntravenous; injection
Gamma-cyclodextrinIntravenous; injection5
GelatinIM–SC; injection16
Gentisic acidIntravenous; injection0.05
Gentisic acid ethanolamideIV (infusion); injection2
Gluceptate sodiumIntravenous; powder, for injection solution20
Gluceptate sodium dihydrateIntravenous; injection7.5
GluconolactoneIM–IV; injection
Glucuronic acidIntravenous; injection
GlutathioneIntramuscular; injection, sustained action0.5
GlycerinSubcutaneous; injection32.5
GlycineIV (infusion); solution, injection42
Glycine hydrochlorideSubcutaneous; solution, injection0.01
Glycocholic acidIntravenous; powder, for injection solution, lyophilized14
Guanidine hydrochlorideIntravenous; injection0.25
HetastarchIntravenous; powder, for injection solution7.36
HistidineIV (infusion); injection37.2
Hyaluronate sodiumIntra-articular; injectable2.3
Hydrochloric acidIntravenous; powder, for injection solution, lyophilized16
Hydrochloric acid, dilutedAN,infiltration; injection1.36
Hydroxyethylpiperazine ethane sulfonic acidIntravenous; injection
Hydroxypropyl-β-cyclodextrinIV (infusion); injection0.4
Insulin beefSubcutaneous; injection0.1
Insulin porkSubcutaneous; injection0.1
IodineIntravenous; injection
Iodoxamic acidIntravenous; injection31
Iofetamine hydrochlorideIntravenous; injection
IsoleucineIV (infusion); injection90
Isopropyl alcoholIntravenous; injection
Isotonic sodium chloride solutionIntravenous; injection0.9
Lactic acidIV (infusion); injection32.2
Lactic acid, DL-IV (infusion); injection2.82
Lactic acid, L-Intravenous; injectable0.4
Lactobionic acidIV (infusion); powder, for injection solution
LactoseIntravenous; injection50
Lactose monohydrateIV (infusion); powder, for injection solution, lyophilized90
Lactose, hydrousIntravenous; powder, for injection solution75
LecithinIntramuscular; injection2.3
Lecithin, eggIntravenous; injectable1.2
Lecithin, hydrogenated soyIntravenous; injection, powder, lyophilized, for liposomal suspension21.3
Lecithin, soybeanIntravenous; powder, for injection solution, lyophilized11.25
LeucineIV (infusion); injection52.6
LidofeninIntravenous; injection
LysineIV (infusion); injection61
Lysine acetateIV (infusion); solution, injection31
Magnesium chlorideIV (infusion); injection10.2
Magnesium stearateImplantation; injection1.50E-03
Maleic acidIV (infusion); injectable0.01
MannitolIV (infusion); powder, for injection solution75
MebrofeninIntravenous; injection
Medronate disodiumIntravenous; injection1
Medronic acidIntravenous; injection2.5
MeglumineIntramuscular; injection15.92
MetacresolSubcutaneous; solution, injection0.52
Metaphosphoric acidIV (infusion); injection0.13
Methanesulfonic acidIV (infusion); powder, for injection solution, lyophilized8.07
MethionineIV (infusion); injection49.2
Methyl boronic acidIntravenous; injection0.2
MethylcelluloseIntra-articular; injection0.1
Methylene blueIntravenous; injection1
MethylparabenIntravenous; injection1.8
Myristyl-gamma-picolinium chlorideIntramuscular; injection0.01
N-(carbamoyl-methoxy PEG-40)-1,2-distearoyl-cephalin sodiumIntravenous; injection, suspension, liposomal0.31
N,N-dimethylacetamideIntravenous; injection1.8
NiacinamideIM–IV; injection2.5
NioximeIntravenous; injection0.2
Nitric acidIV (infusion); injection
NitrogenIntravenous; injection
Octanoic acidIntravenous; injection0.01
Oxidronate sodiumIntravenous; injection0.2
OxyquinolineIntravenous; injection5.00E-03
Peanut oilIntramuscular; injection
PEG sorbitan isostearateIntramuscular; injection
PEG vegetable oilIM–SC; injection7
Pentetate calcium trisodiumIntrathecal; injection
Pentetate pentasodiumIntravenous; injection0.5
Pentetic acidIntravenous; injection0.2
PerflutrenIntravenous; injection
PhenolIM–IV; injection1
Phenol, liquefiedIM–IV; injection0.5
PhenylalanineIV (infusion); injection52.6
Phenylmercuric nitrateIntramuscular; powder, for injection solution
Phosphatidyl glycerol, eggIntravenous; powder, for injection solution, lyophilized4.87
PhospholipidIV (infusion); emulsion, injection12
Phospholipid, eggIV (infusion); injection1.2
Phosphoric acidIV (infusion); injection11.5
Poloxamer 188Intravenous; injection0.6
Polyethylene glycol 200Intramuscular; injection30
Polyethylene glycol 300Intravenous; injection65
Polyethylene glycol 3350Intra-articular; injection3
Polyethylene glycol 400IM–IV; injection20.3
Polyethylene glycol 4000Intramuscular; injection3
Polyethylene glycol 600Intravenous; injection5
PolyglactinIntramuscular; injection, microspheres56.64
PolylactideIntramuscular; powder, for injection suspension, lyophilized26.48
Polyoxyethylene fatty acid estersIM–SC; injection7
Polyoxyl 35 castor oilIV (infusion); injection65
Polyoxyl 40 castor oilIM–SC; injection7
Polyoxyl 60 castor oilIV (infusion); injection20
Polypropylene glycolIM–IV; injectable40
PolysiloxaneIntravenous; injectable
Polysorbate 20IV (infusion); injection2.4
Polysorbate 40IM–IV; injection
Polysorbate 80Intramuscular; injection12
Polyvinyl alcoholIntramuscular; injection, microspheres
Potassium bisulfiteIntravenous; injection
Potassium chlorideIntravenous; solution, injection0.38
Potassium hydroxideIntravenous; injection
Potassium metabisulfiteIV (infusion); solution, injection5
Potassium phosphate, dibasicIV (infusion); injection55.2
Potassium phosphate, monobasicNerve block; injection2.72
Povidone K17Subcutaneous; suspension, injection0.5
ProlineIV (infusion); injection80
Propyl gallateIntramuscular; injection
Propylene glycolIM–IV; injection82.04
PropylparabenIM–IV–SC; injection20
Protamine sulfateIntradermal; injection0.12
Saccharin sodiumIM–IV; injection0.09
Saccharin sodium anhydrousIM–IV; injection0.09
SerineIV (infusion); injection50
Sesame oilIntramuscular; injection70
SiliconeIM–IV; injection
SimethiconeIM–IV; powder, for injection solution
Sodium acetateIV (infusion); injection59.4
Sodium acetate anhydrousIV (infusion); injection6.25
Sodium ascorbateIntravenous; injection1
Sodium benzoateIM–IV; injection10
Sodium bicarbonateIV (infusion); injection83
Sodium bisulfateIM–IV; injection0.32
Sodium bisulfiteIV (infusion); injection10
Sodium carbonateIM–IV; powder, for injection solution70.8
Sodium carbonate decahydrateIntravenous; injection12.42
Sodium carbonate monohydrateIntracardiac; injection
Sodium chlorateIV (infusion); injection15.4
Sodium chlorideIntravenous; injection90
Sodium chloride injectionIntramuscular; injection
Sodium chloride injection, bacteriostaticIntravenous; injection
Sodium cholesteryl sulfateIV (infusion); powder, for injection suspension, lyophilized5.67
Sodium citrateIM–IV; injection40
Sodium cysteinate hydrochlorideIntradiscal; powder, for injection solution
Sodium desoxycholateIV (infusion); powder, for injection solution4.1
Sodium dithioniteIntravenous; injection3
Sodium formaldehyde sulfoxylateIntramuscular; injection0.2
Sodium gluconateIntravenous; injection2.3
Sodium hydroxideIV (infusion); injection13
Sodium hypochloriteIV (infusion); injection1
Sodium iodideIntravenous; powder, for injection solution5
Sodium lactateIntravenous; powder, for injection solution, lyophilized1.87
Sodium lactate, L-IM–IV–SC; injection0.18
Sodium metabisulfiteIM–IV; injection27.5
Sodium phosphateIV (infusion); injection79
Sodium phosphate dihydrateSubcutaneous; injection0.24
Sodium phosphate, dibasicIM–IV; injectable1.74
Sodium phosphate, dibasic anhydrousIM–IV; injection13.92
Sodium phosphate, dibasic, dihydrateIntravenous; solution, injection1.09
Sodium phosphate, dibasic, heptahydrateIntravenous; injection43
Sodium phosphate, monobasicIM–IV; injection1.47
Sodium phosphate, monobasic anhydrousSubcutaneous; injection3.31
Sodium phosphate, monobasic, dihydrateIntravenous; injection0.76
Sodium phosphate, monobasic, monohydrateIntravenous; injection6.21
Sodium pyrophosphateIntravenous; injection1.2
Sodium succinateIntravenous; injection, powder, lyophilized, for liposomal suspension2.7
Sodium sulfateIM–IV; injection
Sodium sulfate anhydrousIntramuscular; injection
Sodium sulfiteIM–IV; injection0.2
Sodium tartrateIntramuscular; injection1.41
Sodium thioglycolateSubcutaneous; injection0.66
Sodium thiomalateIM–IV; injection
Sodium thiosulfateIntravenous; solution
Sodium thiosulfate anhydrousIntravenous; solution0.19
Sodium trimetaphosphateIntravenous; powder, for injection solution
Sorbitan monopalmitateIntramuscular; injection
SorbitolIntrasynovial; injection45
Sorbitol solutionIntramuscular; injection25
Soybean oilIntravenous; injectable10
Stannous chlorideIntravenous; injection0.34
Stannous chloride anhydrousIntravenous; injection5.00E-03
Stannous fluorideIntravenous; injection0.07
Stannous tartrateIntravenous; injection8.00E-03
StarchIntramuscular; injection0.6
SuccimerIntravenous; injection
Succinic acidIM–IV; injection
SucroseIntravenous; injection, powder, lyophilized, for liposomal suspension90
Sulfobutylether β-cyclodextrinIntramuscular; powder, for injection solution, lyophilized, with additives44.14
Sulfur dioxideIV (infusion); solution, injection0.15
Sulfuric acidIM–IV; injection56.6
Sulfurous acidIntramuscular; injection
Tartaric acidIntramuscular; injection0.35
Tartaric acid, DL-IM–IV; injection
Tetrakis(1-isocyano-2-methoxy-2-methyl-propane)-copper(I) tetrafluoroborateIntravenous; injection0.1
TetrofosminIV (infusion); powder, for injection solution, lyophilized0.02
TheophyllineIV (infusion); injection
ThimerosalSubcutaneous; injection0.01
ThioglycerolIntramuscular; injection1
ThreonineIV (infusion); injection45
TinIntravenous; injection8.30E-03
TricaprylinEpidural; injection, suspension, liposomal0.03
Trifluoroacetic acidIV (infusion); powder, for injection solution, lyophilized
TrioleinEpidural; injection, suspension, liposomal0.01
Trisodium citrate dihydrateIntravenous; powder, for injection solution, lyophilized23.52
Trisodium citrate, anhydrousIM–IV; injection16
TromethamineIM–IV; injection, solution1.21
TryptophanIV (infusion); injection15.2
TyrosineIV (infusion); injection3.4
UreaIntramuscular; injection
ValineIV (infusion); injection84
VersetamideIntravenous; injection2.54
ZincSubcutaneous; suspension, injection3.27
Zinc acetateSubcutaneous; powder, for injection suspension0.23
Zinc carbonateSubcutaneous; powder, for injection suspension0.16
Zinc chlorideIntradermal; injection0.04
Zinc oxideSubcutaneous; injection0.01
  • * Highlighted rows are those excipients that were found in our survey.

  • IM = intramuscular.

    IV = intravenous.

    SC = subcutaneous.