4094Levocarnitine / Official Monographs USP 36
Bacterial endotoxins 〈85〉—It contains not more than 0.1may contain a suitable flavor. It contains NLT 90.0% and USP Endotoxin Unit per mg of levocarnitine.NMT 110.0% of the labeled amount of levocarnitine
(C7H15NO3).
pH 〈791〉: between 6.0 and 6.5.
Particulate matter 〈788〉: meets the requirements for IDENTIFICATION
small-volume injections.•A.The retention time of the major peak of the Sample Other requirements—It meets the requirements under In-solution corresponds to that of the Standard solution, jections 〈1〉.both relative to the internal standard, as obtained in the
Assay.
Assay—
0.05 M Phosphate buffer—Dissolve 6.805g of monobasic ASSAY
potassium phosphate in 1000mL of water.•P
ROCEDURE
Mobile pha—Prepare a filtered and degasd mixture of Buffer:0.05 M phosphate buffer, pH 2.4, prepared by acetonitrile and 0.05 M Phosphate buffer (65:35). Adjust mixing 11.5mL of phosphoric acid, 1900mL of water, with phosphoric acid to a pH of 4.7, and mix. Make adjust-and about 100mL of 1N sodium hydroxide
ments if necessary (e System Suitability under Chromatog-Mobile pha:Dissolve 555mg of sodium 1-heptanesul-raphy 〈621〉).fonate in 980mL of Buffer with stirring. Add 20mL of Standard preparation—Dissolve an accurately weighed methanol, and mix.
quantity of USP Levocarnitine RS in water to obtain a solu-Internal standard solution:0.02mg/mL of p-ami-
tion having a known concentration of about 10mg benzoic acid in water
Standard solution:Transfer about 10mg of USP Levo-System suitability solution—Dissolve accurately weighed
carnitine RS to a 5-mL volumetric flask, add 1.0mL of quantities of USP Levocarnitine RS and USP Levocarnitine
the Internal standard solution, and dilute with water to Related Compound A RS in water to obtain a solution hav-
volume.
ing concentrations of about 5.0mg per mL and 0.024mg
Sample stock solution:Equivalent to 10mg/mL of levo-per mL, respectively.
carnitine in water from an accurately measured volume Assay preparation—Pool the contents of ten containers,of Oral Solution
and dilute an accurately measured volume of Injection Sample solution:Wash a 10-mm × 4-cm disposable col-quantitatively with water to obtain a solution having a con-umn containing 500mg of packing L1, in order, with centration of about 10mg of levocarnitine per mL.two column volumes of methylene chloride, two col-Chromatographic system (e Chromatography 〈621〉)—The umn volumes of methanol, and three column volumes liquid chromatograph is equipped with a 205-nm de
tector of water. Pipet 5.0mL of the Sample stock solution into and a 3.9-mm × 30-cm column that contains packing L8.the washed disposable column, and rin the column The flow rate is maintained at about 1mL per minute. The twice with 6.0-mL portions of water. Collect the filtrate system is programmed to provide variable mixtures of ace-and washings in a 25-mL volumetric flask, add 5.0mL tonitrile, Mobile pha, and water. Initially elute 50mL of of the Internal standard solution, and dilute with water acetonitrile, then change the composition linearly over the to volume.
next 20minutes to a mixture of 65% acetonitrile and 35%Chromatographic system
water. Elute 100mL of this mixture, then change the com-(See Chromatography 〈621〉, System Suitability.)
position linearly over the following 20minutes to 100% Mo-Mode:LC
bile pha, and allow the chromatograph to proceed for Detector:UV 225 nm
about 3hours. Chromatograph the System suitability solu-Column:3.9-mm × 30-cm; 10-µm packing L1
tion, and record the peak respons as directed for Proce-Flow rate:1.5mL/min
dure: the resolution, R, between levocarnitine related com-Injection size:40µL
pound A and levocarnitine is not less than 1.0; and the System suitability
relative standard deviation for replicate injections is not Sample:Standard solution
more than 2.0%.[N OTE—The relative retention times for levocarnitine Procedure—Separately inject equal volumes (about 5µL)and p-aminobenzoic acid are 0.56 and 1.0,
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of the Standard preparation and the Assay preparation into respectively.]
the chromatograph, record the chromatograms, and meas-Suitability requirements
ure the respons for the major peaks. Calculate the quan-Resolution:NLT 1.5 between the levocarnitine and in-tity, in mg, of levocarnitine (C7H15NO3) in the portion of ternal standard peaks
Injection taken by the formula:Relative standard deviation:NMT 2.0% for
levocarnitine9型人格测试
(CL/D)(r U/r S)Analysis
Samples:Standard solution and Sample solution
in which C is the concentration, in mg per mL, of USP Levo-Calculate the percentage of the labeled amount of levo-carnitine RS in the Standard preparation; L is the labeled carnitine (C
7H15NO3) in the portion of Oral Solution quantity, in mg, of levocarnitine in each container; D is the taken:
concentration, in mg per mL, of levocarnitine in the Assay
preparation, bad on the labeled quantity per container and Result = (R U/R S) × (C S/C U) × 100
the extent of dilution; and r U and r S are the levocarnitine
peak respons obtained from the Assay preparation and the R U= peak area ratio of levocarnitine to p-Standard preparation, respectively.aminobenzoic acid from the Sample solution
R S= peak area ratio of levocarnitine to p-
aminobenzoic acid from the Standard
solution
C S= concentration of USP Levocarnitine RS in the Levocarnitine Oral Solution Standard solution (mg/mL)
怎样跑步快小诀窍C U= nominal concentration of levocarnitine in the DEFINITION Sample solution (mg/mL)
Levocarnitine Oral Solution is a solution of levocarnitine in
water, and it contains suitable antimicrobial agents. It
USP 36
Official Monographs / Levodopa 4095
Acceptance criteria:90.0%–110.0%Analysis
Samples:Standard solution and Sample solution
SPECIFIC TESTS Calculate the percentage of the labeled amount of levo-•P H 〈791〉: 4.0–6.0
carnitine (C 7H 15NO 3) in the portion of Tablets taken:
ADDITIONAL REQUIREMENTS
Result = (r U /r S ) × (C S /C U ) × 100
•P ACKAGING AND S TORAGE : Prerve in tight containers.•USP R EFERENCE S TANDARDS 〈11〉r U
= peak area of levocarnitine from the Sample
USP Levocarnitine RS
solution
r S = peak area of levocarnitine from the Standard
劳动法辞职规定
solution
C S = concentration of USP Levocarnitine RS in the
Standard solution (mg/mL)
Levocarnitine Tablets
C U = nominal concentration of levocarnitine in the
Sample solution (mg/mL)
DEFINITION
Acceptance criteria:90.0%–110.0%
Levocarnitine Tablets contain NLT 90.0% and NMT 110.0%PERFORMANCE TESTS of the labeled amount of levocarnitine (C 7H 15NO 3).•D ISSOLUTION 〈711〉
IDENTIFICATION
Medium:Water; 900mL •A . The retention time of the major peak of the Sample Apparatus 2:75 rpm solution corresponds to that of the Standard solution , as Time:30 min
obtained in the Assay .Standard solution:Known concentration of USP Levo-•B . C OLOR R EACTION
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carnitine RS in Medium
Analysis:Dissolve 1 Tablet in 5mL of water, filter, and Sample solution:Filtered portion of the solution under add 5mL of 1N hydrochloric acid. Place 2mL of the test, suitably diluted with Medium if necessary filtrate in a test tube, and add a few drops of ammo-Analysis
nium reineckate TS.
Samples:Standard solution and Sample solution
Acceptance criteria:A red-violet precipitate is Proceed as directed in the Assay , making any difications.
Determine the percentage of the labeled amount of levo-ASSAY
carnitine (C 7H 15NO 3) dissolved:
Result = (r U /r S ) × (C S × D × V /L ) × 100
Change to read:
r U = peak area of levocarnitine in the Sample
•P ROCEDURE
solution
Buffer:0.05 M phosphate buffer, pH 4.5, prepared by r S = peak area of levocarnitine in the Standard
dissolving 6.805g of monobasic potassium phosphate solution
in 1L of water C S = concentration of USP Levocarnitine RS in the
v Mobile pha:v USP36Acetonitrile and Buffer (65:35). Ad-Standard solution (mg/mL)
just with phosphoric acid to a pH of 4.7, and mix.D = dilution factor for the Sample solution v
v USP36
V = volume of Medium , 900mL System suitability solution:1.5mg/mL of USP Levo-L = label claim (mg/Tablet)
carnitine RS and 7µg/mL of USP Levocarnitine Related Tolerances:NLT 75% (Q ) of the labeled amount of levo-Compound A RS in water
carnitine (C 7H 15NO 3) is dissolved.
Standard solution:3mg/mL of USP Levocarnitine RS in •U NIFORMITY OF D OSAGE U NITS 〈905〉: Meet the require-water
ments for Weight Variation Sample solution:Transfer 10 Tablets, accurately
weighed, to a 500-mL volumetric flask, and add water ADDITIONAL REQUIREMENTS
河豚长什么样to volume. Shake until the Tablets have disintegrated •P ACKAGING AND S TORAGE : Prerve in pletely, and pass through a filter of 0.45-µm pore •USP R EFERENCE S TANDARDS 〈11〉
size. Dilute a portion of the filtrate quantitatively with USP Levocarnitine RS
water to a nominal concentration of about 3mg/mL of USP Levocarnitine Related Compound A RS
levocarnitine.
2-Propen-1-aminium, 3-carboxy-N ,N ,N -trimethyl-,Chromatographic system
chloride.
(See Chromatography 〈621〉, System Suitability .) C 7H 14ClNO 2179.65
Mode:LC
Detector:UV 205 nm
Column:3.9-mm × 30-cm; 10-µm packing L8Flow rate:1mL/min Injection volume:20µL Levodopa
System suitability
Samples:System suitability solution and Standard solution
Suitability requirements
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Resolution:NLT 1.0 between levocarnitine related
compound A (crotonoylbetaine) and levocarnitine,System suitability solution
种植葡萄技术C 9H 11NO 4
197.19
Relative standard deviation:NMT 2.0% for levo-L -Tyrosine, 3-hydroxy-;
carnitine, Standard solution
(−)-3-(3,4-Dihydroxyphenyl)-L -alanine [59-92-7].
DEFINITION
Levodopa contains NLT 98.0% and NMT 102.0% of levodopa (C 9H 11NO 4), calculated on the dried basis.
