REAGENT SPECIFICATIONS
Acetal,
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Acetaldehyde
(Ethanal; Acetic Aldehyde),
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Acetanilide
(Phenylacetamide; Antifebrin),
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Melting range
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Reaction—
Its saturated solution is neutral to litmus.
Loss on drying
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Residue on ignition (Reagent test):
not more than 0.05%.
Acetic Acid
(6 N Acetic Acid)
—Use Acetic Acid (NF monograph) or prepare a suitable dilution of glacial acetic acid in such a way as to obtain a final concentration of acetic acid between 36.0% and 37.0%, by weight.
Acetic Acid, Diluted
(1 N Acetic Acid)
—Dilute 60.0 mL of glacial acetic acid with water to make 1000 mL.
Residue on evaporation—
Evaporate 50 mL on a steam bath, and dry the residue at 105
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Chloride (Reagent test)—
Five mL shows not more than 0.01 mg of Cl (2 ppm).
Sulfate (Reagent test, Method I )—
Ten mL shows not more than 0.5 mg of SO4 (50 ppm).
Heavy metals (Reagent test)—
Evaporate 20 mL on a steam bath to dryness. Add to the residue 2 mL of the acid, dilute with water to 25 mL, and add 10 mL of hydrogen sulfide TS: any brown color produced is not darker than that of a control containing 0.04 mg of added Pb and 2 mL of the diluted acetic acid (2 ppm).
Acetic Acid, Glacial,
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Acetic Anhydride
(Acetic Oxide; Acetyl Oxide),
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Acetone
(Propanone; Dimethylformaldehyde),
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[Note—For UV spectrophotometric determinations, use ACS reagent grade Acetone Suitable for Use in UV Spectrophotometry. ]
Acetone, Anhydrous,
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Acetone, Neutralized
—To a suitable quantity of acetone add 2 or 3 drops of phenolphthalein TS and a sufficient amount of 0.02 or 0.01 N sodium hydroxide to produce a faint pink color. Prepare neutralized acetone just prior to use.
Acetonitrile
(Methyl Cyanide; Cyanomethane),
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Acetonitrile, Spectrophotometric
—Use ACS reagent grade, which meets also the requirements of the following test.
Spectral purity—
Measure in a 1-cm cell between 250 nm and 280 nm, with a suitable spectrophotometer, against air as the blank: its absorbance is not more than 0.01.
Acetophenone
(Phenylethanone; Phenyl Methyl Ketone),
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Melting range
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Refractive index
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Specific gravity
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p-Acetotoluidide,
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Assay—
Inject an appropriate volume into a gas chromatograph (see Chromatography
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Melting range
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Acetylacetone
(2,4-Pentanedione; Diacetylmethane),
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Assay—
Not less than 98% of C5H8O2, a suitable gas chromatograph equipped with a flame-ionization detector being used and helium being used as the carrier gas. The following conditions have been found suitable: a 3-mm × 1.83-m stainless steel column containing 10% phase G43 on support S1A; the injection port and detector temperatures are maintained at 250
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Refractive index
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Acetyl Chloride,
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Specific gravity
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Acetylcholine Chloride
(Trimethylethanaminium Chloride; Acecoline),
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Melting range
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Reaction—
A solution (1 in 10) is neutral to litmus.
Residue on ignition (Reagent test):
negligible, from 200 mg.
Solubility in alcohol—
A solution of 500 mg in 5 mL of alcohol is complete and colorless.
Percent of acetyl (CH3CO)—
Weigh accurately about 400 mg, previously dried at 105
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Percent of chlorine (Cl)—
Weigh accurately about 400 mg, previously dried at 105
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3-Acetylthio-2-methylpropanoic Acid,
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[Note—A suitable grade is available as
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N-Acetyl-l-tyrosine Ethyl Ester,
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Acrylic Acid
(2-Propenoic Acid; Vinylformic Acid),
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Assay—
Inject an appropriate specimen into a gas chromatograph (see Chromatography
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Refractive index
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Adenine Sulfate,
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Residue on ignition (Reagent test):
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Water—
Dry it at 105
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Adipic Acid
(Hexanedioic Acid; 1,4-Butanedicarboxylic Acid),
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Assay—
Weigh accurately about 0.3 g, and dissolve in 50 mL of alcohol. Add 25 mL of water, mix, and titrate with 0.5 N sodium hydroxide VS to a pH of 9.5. Perform a blank determination, and make any necessary correction. Each mL of 0.5 N sodium hydroxide is equivalent to 36.54 mg of C6H10O4. Not less than 98% is found.
Melting range
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Agar
—Use Agar (NF monograph). When used for bacteriological purposes, it is to be dried to a water content of not more than 20%.
Agarose
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Air–Helium Certified Standard
—A mixture of 1.0% air in industrial grade helium. It is available from most suppliers of specialty gases.
Albumin Bovine Serum
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Alcohol,
Ethanol, Ethyl Alcohol,
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Alcohol, 70 Percent, 80 Percent, and 90 Percent
—Prepare by mixing alcohol and water in the proportions given, the measurements being made at 25
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The proportions of alcohol and water taken to prepare these or any other percentage (v/v) solutions may be determined as follows. Calculate the amount, in mL, of water to be mixed with 100 mL of alcohol taken by the formula:
[94.9(d/c)
![]() in which 94.9 is the percentage (v/v) of C2H5OH in alcohol, 0.8096 is the specific gravity of 94.9% alcohol, d is the specific gravity, obtained from the Alcoholometric Table (see Reference Tables), of the solution containing c% (v/v) of C2H5OH, and 100 is the volume, in mL, of alcohol taken.
Alcohol, Absolute,
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Alcohol, Aldehyde-free
—Dissolve 2.5 g of lead acetate in 5 mL of water, add the solution to 1000 mL of alcohol contained in a glass-stoppered bottle, and mix. Dissolve 5 g of potassium hydroxide in 25 mL of warm alcohol, cool the solution, and add it slowly, without stirring, to the alcohol solution of lead acetate. After 1 hour shake the mixture vigorously, allow it to stand overnight, decant the clear liquid, and recover the alcohol by distillation.
Alcohol, Dehydrated
(Absolute Alcohol),
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Alcohol, Denaturated—
It is ethyl alcohol to which has been added some substance or substances which, while allowing the use of the alcohol in most applications, renders it entirely unfit for consumption as a beverage. The most common denaturants used, either alone or in combination, are the following: methanol, camphor, aldehol, amyl alcohol, gasoline, isopropanol, terpineol, benzene, castor oil, acetone, nicotine, aniline dyes, ether, cadmium iodide, pyridine bases, sulfuric acid, kerosene, and diethyl phthalate. Use a suitable grade.
Alcohol, Neutralized
—To a suitable quantity of alcohol add 2 or 3 drops of phenolphthalein TS and just sufficient 0.02 N or 0.1 N sodium hydroxide to produce a faint pink color. Prepare neutralized alcohol just prior to use.
Alcohol, Tertiary Butyl
—See Butyl Alcohol, Tertiary.
Aldehyde Dehydrogenase
—A white powder. One mg contains not less than 2 enzyme activity units.
Assay—
Transfer about 20 mg, accurately weighed, to a 200-mL volumetric flask, dissolve in 1 mL of water, dilute with an ice-cold solution of bovine serum albumin (1 in 100) to volume, and mix. Use this solution as the Assay preparation. Dissolve 3.3 g of potassium pyrophosphate, 15 mg of dithiothreitol, and 40 mg of edetate disodium in 70 mL of water, adjust with citric acid monohydrate solution (2.1 in 10) to a pH of 9.0 ± 0.1, dilute with water to 100 mL, and mix to obtain a pH 9.0 buffer. Dissolve an accurately weighed quantity of
![]() ![]() ![]() ![]() ![]() [(2.91)(200)/(6.3)(0.1)(1000)](DA/W)
in which DA is as defined above and W is the weight, in g, of aldehyde dehydrogenase taken.
Alizarin Complexone
(Alizarin-3-methyliminodiacetic Acid; Alizarin Fluorine Blue),
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Alkylphenoxypolyethoxyethanol
—A nonionic surfactant. Use a suitable grade.
[Note—A suitable grade is available commercially as “Triton X-100” from Sigma-Aldrich, www.sigma-aldrich.com. ]
Alpha-Chymotrypsin
—25 kDa
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[Note—A suitable grade is available as catalog number 4423 from www.sigma-aldrich.com. ]
Alpha-Cyclodextrin Hydrate
(Alpha-Schardinger Dextrin; Cyclohexaamylose),
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[Note—A suitable grade is available as catalog number 22729 from www.acros.com. ]
Alpha-(2-(methylamino)ethyl)benzyl alcohol
—Use a suitable grade.
Alprenolol Hydrochloride,
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Alum
(Ammonium Alum, Aluminum Ammonium Sulfate),
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Alumina, Activated
(Aluminum Oxide),
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Alumina, Anhydrous
(Aluminum Oxide; Alumina specially prepared for use in chromatographic analysis)
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Aluminon
(Aurin Tricarboxylic Acid, [tri]Ammonium Salt),
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Aluminum,
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Arsenic—
Place 750 mg in a generator bottle (see Arsenic in Reagents under General Tests for Reagents), omitting the pledget of cotton. Add 10 mL of water and 10 mL of sodium hydroxide solution (3 in 10), and allow the reaction to proceed for 30 minutes: not more than a barely perceptible stain is produced on the mercuric bromide test paper.
Aluminum Oxide, Acid-Washed
(Alumina specially prepared for use in chromatographic analysis)
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pH of Slurry—
The pH of a well-mixed slurry of 5 g in 150 mL of ammonia-free and carbon dioxide-free water, after 10 minutes' standing, is between 3.5 and 4.5.
Loss on ignition—
Weigh accurately about 1 g, and ignite, preferably in a muffle furnace at 800
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Silica—
Fuse 500 mg with 10 g of potassium bisulfate for 1 hour in a platinum crucible, cool, and dissolve in hot water: not more than a small amount of insoluble matter remains.
Suitability for chromatographic adsorption—
Dissolve 50 mg of o-nitroaniline in benzene to make 50.0 mL. Dilute 10 mL of the resulting solution with benzene to 100.0 mL, and mix (Solution A).
Weigh quickly about 2 (±0.005) g of specimen in a glass-stoppered weighing bottle, and rapidly transfer it to a dry, glass-stoppered test tube. Add 20.0 mL of Solution A, insert the stopper, shake vigorously for 3 minutes, and allow to settle.
Pipet 10 mL of the clear supernatant into a 100-mL volumetric flask, dilute with benzene to volume, and mix (Solution B).
Determine the absorbances of Solutions A and B at 395 nm, with a suitable spectrophotometer, using benzene as the blank. Calculate the quantity, in mg, adsorbed per g of test specimen by the formula:
[2(1
![]() in which AA and AB are the absorbances of Solutions A and B, respectively; and W is the weight, in g, of the aluminum oxide. Not less than 0.3 mg of o-nitroaniline is adsorbed for each g of the aluminum oxide.
Aluminum Potassium Sulfate,
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Amaranth,
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Aminoacetic Acid
(Glycine),
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Nitrogen content (Reagent test)—
Determine by the Kjeldahl method, using a test specimen previously dried at 105
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Insoluble matter (Reagent test):
not more than 1 mg, from 10 g (0.01%).
Residue on ignition (Reagent test):
not more than 0.05%.
Chloride (Reagent test)—
One g shows not more than 0.1 mg of Cl (0.01%).
Sulfate (Reagent test, Method I)—
Two g shows not more than 0.1 mg of SO4 (0.005%).
Heavy metals (Reagent test):
0.001%, 5 mL of 1 N hydrochloric acid VS being used to acidify the solution of the test specimen.
Iron
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4-Aminoantipyrine,
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Melting range
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2-Aminobenzonitrile
(Anthranilonitrile),
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Melting range
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4-Amino-6-chloro-1,3-benzenedisulfonamide,
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Residue on ignition (Reagent test):
not more than 2 mg from 2 g (0.1%).
Absorbance—
A 1 in 200,000 solution in methanol exhibits absorbance maxima at about 223 nm, 265 nm, and 312 nm. Its absorptivity (see Spectrophotometry and Light-Scattering
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4-Amino-2-chlorobenzoic Acid,
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Melting range
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2-Amino-5-chlorobenzophenone,
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7-Aminodesacetoxycephalosporanic Acid,
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Test solution:
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Standard solution:
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Eluant:
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Visualization:
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1-(2-Aminoethyl)piperazine,
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Assay—
Inject an appropriate specimen into a suitable gas chromatograph (see Chromatography
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Refractive index
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Aminoguanidine Bicarbonate
(Aminoguanidine Hydrogen Carbonate),
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Assay—
Dissolve about 34 mg, accurately weighed, in 50 mL of glacial acetic acid. Titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary corrections. Each mL of 0.1 N perchloric acid is equivalent to 13.61 mg of CH6N4·H2CO3. Not less than 98.5% is found.
Melting point
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2-Aminoheptane
(2-Heptylamine; 1-Methylhexylamine),
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N-Aminohexamethyleneimine
(N-Aminohomopiperidine, 1-Aminohomopiperidine),
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Assay—
Inject an appropriate specimen into a suitable gas chromatograph (see Chromatography
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Refractive index
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4-Amino-3-hydroxy-1-naphthalenesulfonic Acid
(1,2,4-Aminonaphtholsulfonic Acid; 1-Amino-2-naphthol-4-sulfonic Acid),
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2-Aminophenol
(o-Aminophenol; 2-Hydroxyaniline),
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m-Aminophenol
(3-Amino-1-Hydroxybenzene),
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Assay—
Dissolve about 1.5 g, accurately weighed, in about 400 mL of water in a 500-mL volumetric flask, dilute with water to volume, and mix. Transfer 25.0 mL of this solution to an iodine flask, add 50.0 mL of 0.1 N bromine VS, dilute with 50 mL of water, add 5 mL of hydrochloric acid, and immediately insert the stopper in the flask. Shake for 1 minute, allow to stand for 2 minutes, and add 5 mL of potassium iodide TS through the slightly loosened stopper. Shake thoroughly, allow to stand for 5 minutes, remove the stopper, and rinse it and the neck of the flask with 20 mL of water, adding the rinsing to the flask. Titrate the liberated iodine with 0.1 N sodium thiosulfate VS, adding 3 mL of starch TS as the endpoint is approached. From the volume of 0.1 N sodium thiosulfate used, calculate the volume, in mL, of 0.1 N bromine consumed by the test specimen. Each mL of 0.1 N bromine is equivalent to 1.819 mg of C6H7NO: not less than 99.5% is found.
Melting range
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Loss on drying
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Residue on ignition (Reagent test):
negligible, from 2 g.
p-Aminophenol
(p-Hydroxyaniline),
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3-Amino-1-propanol,
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Boiling range (Reagent test):
between 184
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Refractive index
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3-Aminopropionic Acid
(
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3-Aminosalicylic Acid,
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Ammonia Detector Tube
—A fuse-sealed glass tube so designed that gas may be passed through it and containing suitable absorbing filters and support media for the indicator bromophenol blue.
Measuring range:
5 to 70 ppm.
[Note—Available from Draeger Safety, Inc., www.draeger.com, or from Gastec Corp., www.gastec.co.jp, distributed in the USA by www.nextteq.com. ]
Ammonia Water, 25 Percent
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Ammonia Water, Stronger
(Ammonium Hydroxide)—
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Ammonium Acetate,
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Ammonium Bicarbonate (Ammonium Hydrogen Carbonate),
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Ammonium Bisulfate
(Ammonium Hydrogen Sulfate),
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Assay—
Dissolve about 300 mg, accurately weighed, in 50 mL of a mixture of water and alcohol (25:25). Titrate with 0.1 N sodium hydroxide VS, determining the endpoint potentiometrically. Perform a blank determination and make any necessary correction. Each mL of 0.1 N sodium hydroxide is equivalent to 11.51 mg of NH4HSO4. Not less than 98% is found.
Ammonium Bromide,
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Ammonium Carbonate
(Hartshorn Salt)
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Ammonium Chloride
(Salmiac),
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Ammonium Citrate, Dibasic
(Citric Acid Diammonium Salt),
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Ammonium Fluoride,
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Ammonium Formate
(Formic Acid Ammonium Salt),
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Ammonium Hydroxide
(Ammonium Aqueous),
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Ammonium Hydroxide, 6 N—
Prepare by diluting 400 mL of Ammonia Water, Stronger (see Reagents section) with water to make 1000 mL.
Ammonium Molybdate,
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Ammonium Nitrate,
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Ammonium Oxalate,
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Ammonium Persulfate
(Ammonium Peroxydisulfate),
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Ammonium Phosphate, Dibasic
(Diammonium Hydrogen Phosphate),
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Ammonium Phosphate, Monobasic
(Ammonium Dihydrogen Phosphate),
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Ammonium Pyrrolidinedithiocarbamate
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Ammonium Reineckate
(Reinecke Salt),
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Sensitiveness—
Dissolve 50 mg in 10 mL of water. Add 0.2 mL of the solution to 1 mL of a solution of 10 mg of choline chloride in 20 mL of water, and shake gently: a distinct precipitate forms within 5 to 10 seconds.
Ammonium Sulfamate,
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Ammonium Sulfate,
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Ammonium Thiocyanate
(Ammonium Rhodanide),
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Ammonium Vanadate
(Ammonium Metavanadate),
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Assay—
Weigh accurately about 500 mg, transfer to a suitable container, add 30 mL of water and 2 mL of dilute sulfuric acid (1 in 4), swirl to dissolve, and pass sulfur dioxide gas through the solution until reduction is complete and the solution is bright blue in color. Boil gently while passing a stream of carbon dioxide through the solution to remove any excess sulfur dioxide, then cool, and titrate with 0.1 N potassium permanganate VS. Each mL of 0.1 N potassium permanganate consumed is equivalent to 11.7 mg of NH4VO3. Not less than 98.0% is found.
Solubility in ammonium hydroxide—
Dissolve 1 g in a mixture of 3 mL of ammonium hydroxide and 50 mL of warm water: the solution is clear and colorless.
Carbonate—
To 500 mg add 1 mL of water and 2 mL of diluted hydrochloric acid: no effervescence is produced.
Chloride—
Dissolve 250 mg in 40 mL of hot water, add 2 mL of nitric acid, and allow to stand for 1 hour. Filter, and to the filtrate add 0.5 mL of silver nitrate TS: any turbidity produced does not exceed that of a blank containing 0.5 mg of added Cl (0.2%).
Sulfate—
Dissolve 500 mg in 50 mL of hot water, and add 2 mL of diluted hydrochloric acid and 1.5 g of hydroxylamine hydrochloride. Heat at 60
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Amyl Acetate
(Pentyl Acetate),
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Change to read:
Amyl Alcohol
(Isoamyl Alcohol),
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tert-Amyl Alcohol,
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Specific gravity
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Boiling range (Reagent test):
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Residue on evaporation—
Evaporate 50 mL (40 g) on a steam bath, and dry at 105
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Acids and esters—
Dilute 20 mL with 20 mL of alcohol, add 5.0 mL of 0.1 N sodium hydroxide VS, and reflux gently for 10 minutes. Cool, add 2 drops of phenolphthalein TS, and titrate the excess sodium hydroxide with 0.1 N hydrochloric acid VS: not more than 0.75 mL of the 0.10 N sodium hydroxide is consumed, correction being made for the amount consumed in a blank (0.06% as amyl acetate).
Aldehydes—
Shake 5 mL with 5 mL of potassium hydroxide solution (30 in 100) in a glass-stoppered cylinder for 5 minutes, and allow to separate: no color develops in either layer.
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(E)-Anethole
(1-Methoxy-4-(1-propenyl)benzene),
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Aniline,
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Aniline Blue
(Certified Biological Aniline Blue)
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Aniline Sulfate,
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Anion-Exchange Resin, Chloromethylated Polystyrene-Divinylbenzene
—Strongly basic, cross-linked resin containing quaternary ammonium groups. It consists of small, moist, yellow beads having a characteristic amine odor. It is available in the chloride form which can be converted to the hydroxide form by regeneration with sodium hydroxide solution (1 in 4). For satisfactory regeneration a contact time of about 25 minutes is required, after which it must be washed with water until neutral. Suitable for use in column chromatography.
[Note—A suitable resin is “Amberlite IRA-400,” available from Sigma-Aldrich, www.sigma-aldrich.com. ]
Anion-Exchange Resin, Strong, Lightly Cross-Linked, in the Chloride Form
—Use a suitable grade.
[Note—A suitable resin is “AG 1-X4, catalog number 140-1331,” produced by BioRad Laboratories, www.bio-rad.com. ]
Anion-Exchange Resin, Styrene-Divinylbenzene—
Strongly basic, cross-linked resin containing quaternary ammonium groups and about 8% of divinylbenzene. It is available in the chloride form in the 50- to 100-, 100- to 200-, and 200- to 400-mesh sizes. It can be converted to the hydroxide form by regeneration with a sodium hydroxide solution (5 in 100). Insoluble in water, in methanol, and in acetonitrile. Suitable for use in column chromatography.
[Note—A suitable resin is Dowex 1X8, produced by Dow Chemical Co. (www.dow.com) and available through Sigma-Aldrich (www.sigma-aldrich.com). ]
Anion-Exchange Resin, 50- to 100-Mesh, Styrene-Divinylbenzene
—Strongly basic, cross-linked resin containing quaternary ammonium groups and about 4% of divinylbenzene. It consists of tan-colored beads that may be relatively free flowing. It is available in the chloride form which can be converted to the hydroxide form by regeneration with a sodium hydroxide solution (5 in 100). For satisfactory regeneration a contact time of at least 30 minutes is required after which it must be washed free of excess alkali. Insoluble in water, in methanol, and in acetonitrile. Suitable for use in column chromatography.
[Note—A suitable resin is “Dowex 1X4,” available from Sigma-Aldrich, www.sigma-aldrich.com. ]
Moisture content of fully regenerated and expanded resin—
Transfer 10 to 12 mL of the resin (as received) to a flask, and convert it completely to the chloride form by stirring with 150 mL of hydrochloric acid (5 in 100) for not less than 30 minutes. Decant the acid, and wash the resin in the same manner with distilled water until the wash water is neutral to litmus.
Transfer 5 to 7 mL of the regenerated resin to a glass filtering crucible, and remove only the excess surface water by very careful suction filtration. Transfer the conditioned, dried resin to a tared weighing bottle, and weigh. Dry in a vacuum oven at 100
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Total new volume capacity—
Transfer 2.5 to 3 mL of the conditioned, undried (See Moisture content, above) resin to a 5-mL graduated cylinder, and fill it with water. Remove any air bubbles from the resin bed with a stainless steel wire, and settle the resin to its minimum volume by tapping the graduated cylinder. Record the volume of the resin.
Transfer the resin with 100 mL of water to a 250-mL flask. Add 2 mL of sulfuric acid, heat to 70
![]() ![]() (net mL AgNO3 × N)/(mL of resin) = mEq/mL
The total exchange capacity of the regenerated, wet resin is more than 1.0 mEq per mL.
Wet screen analysis—
The purpose of this test is to identify properly the mesh size of the resin. To obtain an accurate screen analysis requires special apparatus and technique.
Add 150 mL of resin to 200 mL of distilled water in an appropriate bottle, and allow it to stand at least 4 hours to completely swell the resin.
Transfer by means of a graduated cylinder 100 mL of settled and completely swollen resin to the top screen of a series (20-, 50-, 100-mesh) of 20.3-cm brass screens. Thoroughly wash the resin on each screen with a stream of distilled water until the resin is completely classified, collecting the wash water in a suitable container. Wash the beads remaining on the respective screens back into the 100-mL cylinder, and record the volume of settled resin on each screen: not less than 80% of the resin is between 50- and 100-mesh.
p-Anisaldehyde
(4-Methoxybenzaldehyde),
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Boiling temperature:
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Density:
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Refractive index
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p-Anisidine,
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Anisole,
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Assay—
Inject an appropriate specimen (about 0.5 µL) into a suitable gas chromatograph (see Chromatography
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Refractive index
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Anthracene,
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Melting range
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Anthrone,
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Anti-D Reagent—
The reagent can be monoclonal (low protein) or polyclonal (high-protein) and 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 that this reagent is different from Anti-D (Rho) Reagent. Consult manufacturer's package insert to ensure that the reagent is suitable for the Weak Anti-D test and does not contain other antibodies that will react when antihuman immunoglobulin is added.
[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. ]
Anti-D (Rho) Reagent—
The reagent can be monoclonal or polyclonal and must be obtained from manufacturers or suppliers licensed by the Center for Biologics Evaluation and Research, Food and Drug Administration for use in microplate tests. The use of reagents from an unlicensed manufacturer or supplier may invalidate the results. Note that this reagent is different from Anti-D Reagent. Consult manufacturer's package insert to ensure that it is Anti-D (Rho) Reagent and not Anti-D Reagent.
[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. ]
Antifoam Reagent
—A 10% silicone–glycol emulsion, white in appearance. Nonionic but miscible with cool water.
[Note—A suitable grade is available as “Antifoam Reagent, ”catalog number 2210, from Dow Corning Corporation, www.dowcorning.com. ]
Antihuman Globulin Reagent—
The reagent can be polyspecific or anti-immunoglobulin (Anti-IgG) and 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. ]
Antimony Pentachloride,
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[Caution—Antimony pentachloride causes severe burns, and the vapor is hazardous.
]
Assay (SbCl5)—
Accurately weigh a glass-stoppered, 125-mL flask, quickly introduce about 0.3 mL of the test specimen, and reweigh. Dissolve with 20 mL of diluted hydrochloric acid (1 in 5), and add 10 mL of potassium iodide solution (1 in 10) and 1 mL of carbon disulfide. Titrate the liberated iodine with 0.1 N sodium thiosulfate VS. The brown color will gradually disappear from the solution, and the last traces of free iodine will be collected in the carbon disulfide, giving a pink color. When this pink color disappears the endpoint has been reached. Each mL of 0.1 N sodium thiosulfate is equivalent to 14.95 mg of SbCl5: not less than 99.0% of SbCl5 is found.
Sulfate (Reagent test, Method II)—
Dissolve 4.3 mL (10 g) in the minimum volume of hydrochloric acid, dilute with water to 150 mL, neutralize with ammonium hydroxide, and filter. To the filtrate add 2 mL of hydrochloric acid: the solution, 10 mL of barium chloride TS being used, yields not more than 1.3 mg of residue, correction being made for a complete blank test (0.005%).
Arsenic—
Add 10 mL of a recently prepared solution of 20 g of stannous chloride in 30 mL of hydrochloric acid to 100 mg of specimen dissolved in 5 mL of hydrochloric acid. Mix, transfer to a color-comparison tube, and allow to stand for 30 minutes. Any color in the solution of the specimen should not be darker than that in a control containing 0.02 mg of arsenic (As), which has been treated in the same manner as the test specimen, when viewed downward over a white surface (0.02% of As).
Substances not precipitated by hydrogen sulfide (as SO4)—
Dissolve 0.90 mL (2 g) in 5 mL of hydrochloric acid, and dilute with 95 mL of water. Precipitate the antimony completely with hydrogen sulfide, allow the precipitate to settle, and filter, being careful not to transfer much of the precipitate to the filter paper. (Retain the precipitate.) To 50 mL of the filtrate, add 0.5 mL of sulfuric acid, evaporate in a tared porcelain crucible to dryness, and ignite at 800 ± 25
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Iron
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Other heavy metals (as Pb)—
Dissolve the precipitate on the filter paper from the test for Substances not precipitated by hydrogen sulfide, with 75 mL of a solution containing 6 g of sodium sulfide and 4 g of sodium hydroxide dissolved in and diluted with water to 100 mL. Collect the filtrate in the original flask containing the remainder of the sulfide precipitate. Warm the solution to dissolve the soluble sulfides, and allow the insoluble sulfides to settle. Filter, wash thoroughly with hydrogen sulfide TS, and dissolve any precipitate remaining on the filter paper with 10 mL of hot diluted hydrochloric acid. Dilute the filtrate with water to 50 mL. Neutralize a 25-mL portion of this solution with 1 N sodium hydroxide, and add 1 mL of 1 N acetic acid and 10 mL of hydrogen sulfide TS. Any brown color should not exceed that produced by 0.05 mg of lead ion in an equal volume of solution containing 1 mL of 1 N acetic acid and 10 mL of hydrogen sulfide TS (0.005%).
Antimony Trichloride
(Antimonous Chloride),
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Antithrombin III—
Antithrombin III human (heparin cofactor, factor IIa inhibitor, and factor Xa inhibitor) is a serine protease inhibitor. It is a glycoprotein having a molecular weight of 58,000 Da.
One Antithrombin III Unit is the amount found in 1 mL of normal human plasma. The potency of antithrombin III is not less than 4.0 Antithrombin III Units per mg of protein when tested in the presence of heparin. It exhibits 90% homogeneity when tested by SDS-PAGE.
Antithrombin III for test or assay purposes contains no detectable heparin. Test as follows. To a solution containing 1 Antithrombin III Unit per mL, add 1 µL of toluidine blue solution. In the presence of heparin, the color changes from blue to purple.
Aprobarbital,
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Assay—
Dissolve about 200 mg, previously dried at 105
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Melting range
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Arsenazo III Acid,
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Melting temperature
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Arsenic Trioxide,
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[Note—Arsenic Trioxide of a quality suitable as a primary standard is available from the National Institute of Standards and Technology, Office of Standard Reference Materials, www.nist.gov, as standard sample No. 83. ]
l-Asparagine
(l-2-Aminosuccinamic Acid),
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Specific rotation
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Residue on ignition (Reagent test):
not more than 0.1%.
Chloride (Reagent test)—
One g shows not more than 0.03 mg of Cl (0.003%).
Sulfate (Reagent test, Method I )—
One g shows not more than 0.05 mg of SO4 (0.005%).
Heavy metals (Reagent test):
0.002%.
Nitrogen content, Method II
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l-Aspartic Acid,
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Azure A,
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
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