Add the following:
IgG-Coated Red Cells—
Red cells coated with human immunoglobulin (IgG).The reagent must be obtained from manufacturers or suppliers licensed by the Center for Biologics Evaluation and Research,Food and Drug Administration.The use of reagents from an unlicensed manufacturer or supplier may invalidate the results.
[NOTE—There are many manufacturers and suppliers of these reagents that are licensed by the Center for Biologics Evaluation and Research,Food and Drug Administration.Some examples of licensed manufacturers or suppliers are the following:Gamma Biologics,Houston,TX;and Ortho Diagnostics,Raritan,NJ.]USP28
USP28
Imidazole, C3H4N2—68.08—White to light yellow crystals.Freely soluble in water.Use ACSreagent grade.
Iminostilbene, C14H11N—193.24—Yellow-orange powder.Sparingly soluble in ethyl acetate.
Indene, C9H8—116.16—Colorless liquid.
Assay—
Inject an appropriate specimen into a suitable gas chromatograph (see Chromatography á621ñ)equipped with a flame-ionization detector,helium being used as the carrier gas.The following conditions have been found suitable:a 0.25-mm ×10-m capillary column coated with a 1-µm layer of methylsilicone;the injection port temperature is maintained at 200
;the detector temperature is maintained at 300;the column temperature is maintained at 100and programmed to rise 10per minute to 250.The area of the indene peak is not less than 99%of the total peak area.
;the detector temperature is maintained at 300;the column temperature is maintained at 100and programmed to rise 10per minute to 250.The area of the indene peak is not less than 99%of the total peak area.
Refractive index á831ñ:
between 1.5749and 1.5769at 20.
.
Indicators —See separate subsection.
Indigo Carmine —Use Indigotindisulfonate Sodium.
Indole (2,3-Benzopyrrole), C8H7N—117.14[170-72-9]—Use a suitable grade.
Indole-3-carboxylic Acid, C9H7NO2—161.2[771-50-6]—Use a suitable grade.
Inositol (Hexahydroxycyclohexane), C6H6(OH)6—180.16—Fine,white crystals or a white,crystalline powder,odorless,and stable in air.Its solutions are neutral to litmus.Optically inactive.One g dissolves in 5.7mLof water.Slightly soluble in alcohol;insoluble in ether and in chloroform.Store in well-closed containers.
Loss on drying á731ñ—
Dry it at 105for 4hours:it loses not more than 0.5%of its weight.
for 4hours:it loses not more than 0.5%of its weight.
Residue on ignition(Reagent test):
not more than 0.1%.
Iobenguane Sulfate (m-Iodobenzylguanidine Hemisulfate Salt), C8H10IN3·½H2SO4—324.1—White powder.Freely soluble in methanol.
Assay—
When tested by thin-layer chromatography,with the use of plates coated with chromatographic silica gel mixture,a developing system consisting of a mixture of butyl alcohol,water,and acetic acid (60:25:15),and examined under short-wavelength UVlight,not more than a single impurity spot of not more than 0.5%is observed.
Iodic Acid, HIO3—175.91—Use ACSreagent grade.
Iodine, I—At.Wt.126.9045—Use ACSreagent grade.
Iodine Monobromide, IBr—206.81—Black,gray or blue-purple crystals,crystalline needles,or crystalline chunks.
Assay—
Place about 100mLof acetic acid in a 150-mLbeaker.Separately dissolve 2g of potassium iodide in a minimum volume of water,add this solution to the acetic acid,and mix.Transfer about 200mg of Iodine Monobromide,accurately weighed,to the beaker containing the potassium iodide and acetic acid mixture,and stir to dissolve.Titrate immediately with 0.1Nsodium thiosulfate VS,determining the endpoint potentiometrically (see Titrimetry á541ñ).Perform a blank determination,and make any necessary correction.Each mLof 0.1Nsodium thiosulfate is equivalent to 20.681mg of IBr.Not less than 97.5%is found.
Iodine Monochloride, ICl—162.36—Use ACSreagent grade.
Add the following:
Iodoethane,
C2H5I—155.9[75-03-6]—Use a suitable grade.USP28
p-Iodonitrotetrazolium Violet, (2-(4-iodophenyl)-3-(4-nitrophenyl)-5-phenyltetrazolium chloride), C19H13ClIN5O2—505.70—Light yellow powder.
Assay—
When tested by thin-layer chromatography,with the use of plates coated with chromatographic silica gel mixture and a developing system consisting of a mixture of amyl alcohol,formic acid,and water (8:1:1),sprayed with 0.1%sodium thiosulfate solution,and examined under short-wavelength UVlight,a single spot is exhibited,with trace impurities.
Melting point á791ñ:
240,with decomposition.
,with decomposition.
Ion-Exchange Resin —An intimate mixture of 4parts of a strongly acidic cation-exchanger in the hydrogen form (produced by sulfonation of a styrene-divinylbenzene copolymer,representing 8to 10%divinylbenzene)and 6parts of a strongly basic anion-exchanger in the hydroxyl form (produced by amination with trimethylamine of a chloromethylated styrene-divinylbenzene copolymer,representing 3to 5%divinylbenzene).
Iron Wire, Fe—At.Wt.55.847—Use a suitable grade.
Isoamyl Alcohol —Use Amyl Alcohol.
Isobutyl Acetate, C6H12O2—116.16—Clear,colorless liquid.Slightly soluble in water.Miscible with alcohol.
Assay—
Inject an appropriate specimen into a suitable gas chromatograph (see Chromatography á621ñ)equipped with a flame-ionization detector,helium being used as the carrier gas.The following conditions have been found suitable:a 0.25-mm ×30-m capillary column coated with G2.The injection port temperature is maintained at 130;the column temperature is maintained at 30and programmed to rise 10per minute to 180and held there for 10minutes.The detector temperature is maintained at 300.The area of the main peak is not less than 99%of the total peak area.
;the column temperature is maintained at 30and programmed to rise 10per minute to 180and held there for 10minutes.The detector temperature is maintained at 300.The area of the main peak is not less than 99%of the total peak area.
Specific gravity á841ñ:
between 0.863and 0.868.
Refractive index á831ñ:
between 1.3900and 1.3920at 20.
.
Isobutyl Alcohol (2-Methyl-1-propanol), (CH3)2CHCH2OH—74.12—Use ACSreagent grade.
4-Isobutylacetophenone, C12H16O—176—Pale yellow liquid.Soluble in chloroform,in glycerols,in alcohols,in ether,and in fatty oils;insoluble in water.Use a suitable grade.
N-Isobutylpiperidone, C9H17NO—155.24—Use a suitable grade.
Isoflupredone Acetate (9-a-Fluoroprednisolone Acetate), C23H29FO6—420.47—Use Isoflupredone Acetate USP.
Isomaltotriose (a-D-Glucosyl-(1-6)-a-D-glucosyl-(1-6)-a-D-glucose), C18H32O16—504.4[3371-50-4]—White lyophilized powder.Use a suitable grade.
Isonicotinic Acid, C6H5NO2—123.11—Use a suitable grade.
Isonicotinic Acid Hydrazide —Use Isoniazid.
Isooctane —See 2,2,4-Trimethylpentane.
Isopropyl Acetate, C5H10O2—102.13[108-21-4]—Use a suitable grade.
Isopropyl Alcohol (2-Propanol), (CH3)2CHOH—60.10—Use ACSreagent grade.
[NOTE—For use in assays and tests involving UVspectrophotometry,use ACSreagent grade Isopropyl Alcohol Suitable for Use in UV Spectrophotometry.]
Isopropyl Alcohol,Dehydrated —Use Isopropyl Alcohol that previously has been dried by being shaken with a suitable molecular sieve capable of adsorbing water,and filtered.
Isopropyl Ether —See Diisopropyl Ether.
Isopropyl Iodide (2-Iodopropane), C3H7I—169.99—Colorless liquid,discoloring upon exposure to air and light.Sparingly soluble in water;miscible with alcohol,with benzene,with chloroform,and with ether.
Density:
between 1.696and 1.704.
Refractive index á831ñ:
between 1.4987and 1.4997at 20.
.
Isopropyl Myristate, C17H34O2—270.45—Use Isopropyl Myristate(NFmonograph).For use as a solvent in sterility test procedures,Isopropyl Myristate conforms to the following additional specification:
pHof water extract—
Transfer 100mLto a 250-mLcentrifuge bottle,add 10mLof twice-distilled water,close the bottle with a suitable closure,and shake vigorously for 60minutes.Centrifuge the mixture at 1800rpm for 20minutes,aspirate the upper (isopropyl myristate)layer,and determine the pHof the residual water layer:the pHis not less than 6.5.
Isopropyl Myristate not conforming to the test for pHof water extractmay be rendered suitable for use in sterility test procedures as follows:
Using a 20-mm ×20-cm glass column,add activated alumina,and tamp down to a height of 15cm.Pass 500mLof the isopropyl myristate through the column,using a slight positive pressure to maintain an even flow,and use the eluate collected directly in the sterility test procedure.
Isopropyl Salicylate, C6H4OHCOOCH(CH3)2—180.20—Colorless liquid.
Assay—
Inject an appropriate specimen into a suitable gas chromatograph (see Chromatography á621ñ)equipped with a flame-ionization detector,helium being used as the carrier gas.The following conditions have been found suitable:a 2-mm ×1.8-m glass column packed with 7%phase G2on support S1A;the injection port temperature is maintained at 250;the detector temperature is maintained at 310;the column temperature is maintained at 50and programmed to rise 10per minute to 250.The area of the main peak is not less than 97%of the total peak area.
;the detector temperature is maintained at 310;the column temperature is maintained at 50and programmed to rise 10per minute to 250.The area of the main peak is not less than 97%of the total peak area.
Isopropylamine (2-Aminopropane), C3H7NH2—59.11—Clear,colorless,flammable liquid having a strong odor of ammonia.Miscible with water,with alcohol,and with ether.
Assay—
Transfer about 0.2g,accurately weighed,to a suitable container,add 50mLof water,and mix.Titrate with 0.1Nhydrochloric acid VS,using a mixture of methyl red TSand bromocresol green TS(1:5)as indicator.Each mLof 0.1Nhydrochloric acid is equivalent to 59.11mg of C3H9N.Not less than 98%is found.
Boiling range(Reagent test)—
Not less than 95%distils between 31and 33.
and 33.
Refractive index á831ñ:
between 1.3743and 1.3753,at 20.
.
Isorhamnetin, C16H12O7—316.27[418-19-3]—Yellow powder.
Melting point:
greater than 300.
.