Azithromycin
C38H72N2O12 748.98
C38H72N2O12·H2O 767.00
C38H72N2O12·2H2O 785.02
1-Oxa-6-azacyclopentadecan-15-one, 13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-
-d-xylo-hexopyranosyl]oxy]-, [2R(2R*,3S*,4R*,5R*,8R*,10R*,11R*,12S*,13S*,14R*)];
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl--l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one;
9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin A
Anhydrous
[83905-01-5].
Monohydrate[121479-24-4].
Dihydrate[117772-70-0].
(ay zith'' roe mye' sin).
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C38H72N2O12 748.98
C38H72N2O12·H2O 767.00
C38H72N2O12·2H2O 785.02
1-Oxa-6-azacyclopentadecan-15-one, 13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)--d-xylo-hexopyranosyl]oxy]-, [2R(2R*,3S*,4R*,5R*,8R*,10R*,11R*,12S*,13S*,14R*)];
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one;
9-Deoxo-9a-aza-9a-methyl-9a-homoerythromycin A
Anhydrous
[83905-01-5].Monohydrate
[121479-24-4].Dihydrate
[117772-70-0].DEFINITION
Azithromycin is anhydrous or contains one or two molecules of water of hydration. It contains the equivalent of NLT 945 µg and NMT 1030 µg of azithromycin (C38H72N2O12) per mg, calculated on the anhydrous basis.
IDENTIFICATION
• A. Infrared Absorption 
197K
:
If a difference appears in the IR spectra of the analyte and the standard, dissolve equal portions of the test specimen and the Reference Standard in equal volumes of methanol. Evaporate the solutions to dryness on a water bath, and dry at 80
for 30 min under vacuum. Perform the test on the residues.
197K:
If a difference appears in the IR spectra of the analyte and the standard, dissolve equal portions of the test specimen and the Reference Standard in equal volumes of methanol. Evaporate the solutions to dryness on a water bath, and dry at 80 for 30 min under vacuum. Perform the test on the residues.
• B.
The retention time of the azithromycin peak in the Sample solution corresponds to that in the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
[Note—Use water that has a resistivity of NLT 18 Mohm-cm. ]
Mobile phase:
Dissolve 5.8 g of monobasic potassium phosphate in 2130 mL of water, and add 870 mL of acetonitrile. Adjust with 6 mL of 10 N potassium hydroxide to a pH of 11.0 ± 0.1, and filter.
Standard stock solution:
0.165 mg/mL of USP Azithromycin RS in acetonitrile. [Note—Sonicate as necessary. ]
Standard solution:
3.3 µg/mL of USP Azithromycin RS from the Standard stock solution in Mobile phase
Sample stock solution:
0.165 mg/mL of Azithromycin in acetonitrile. [Note—Sonicate as necessary. ]
Sample solution:
3.3 µg/mL of azithromycin from the Sample stock solution in Mobile phase
System suitability stock solution:
0.16 mg/mL of USP Azaerythromycin A RS in acetonitrile and Mobile phase (1:9). [Note—Dissolve in acetonitrile, using 10% of the final volume. Swirl and sonicate to dissolve. Dilute with Mobile phase to volume. ]
System suitability solution:
3.3 µg/mL of azithromycin from the Sample stock solution and 3.2 µg/mL of azaerythromycin A from the System suitability stock solution in Mobile phase
Chromatographic system
Mode:
LC
Detector:
Amperometric electrochemical detector
Detector type:
Dual glassy carbon electrodes
Detector mode:
Oxidative screen mode
Detector settings:
Electrode 1 set at +0.70 ± 0.05 V, electrode 2 set at +0.82 ± 0.05 V, background current optimized to 85 ± 15 nanoamperes
Column
Guard column:
4.6-mm × 5-cm; 5-µm packing L29
Analytical column:
4.6-mm × 15-cm; 5-µm packing L29 or 3-µm packing L49 without the guard column
Flow rate:
1.5 mL/min
Injection size:
50 µL
System suitability
Samples:
Standard solution and System suitability solution
[Note—The relative retention times for azaerythromycin A and azithromycin with the L29 column are 0.7 and 1.0, respectively. The relative retention times for azaerythromycin A and azithromycin with the L49 column are 0.8 and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 2.5 between azaerythromycin A and azithromycin, System suitability solution
Column efficiency:
NLT 1000 theoretical plates, Standard solution
Tailing factor range:
0.9–1.5 for azithromycin, Standard solution
Relative standard deviation:
NMT 2.0%, Standard solution
Analysis
Samples:
Standard solution and Sample solution
Calculate the quantity, in µg, of C38H72N2O12 in each mg of Azithromycin taken:
Result = (rU/rS) × (CS/CU) × P
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Azithromycin RS in the Standard solution |
| CU | = | = concentration of Azithromycin in the Sample solution |
| P | = | = potency of USP Azithromycin RS (µg/mg of azithromycin) |
Acceptance criteria:
945–1030 µg/mg on the anhydrous basis
IMPURITIES
Inorganic Impurities
• Residue on Ignition 281:
NMT 0.3%, the charred residue being moistened with 2 mL of nitric acid and 5 drops of sulfuric acid
281:
NMT 0.3%, the charred residue being moistened with 2 mL of nitric acid and 5 drops of sulfuric acid
• Heavy Metals, Method II 231:
NMT 25 ppm
231:
NMT 25 ppm
Organic Impurities
• Procedure 1
[Note—Use Organic Impurities, Procedure 2 when the impurity profile includes azithromycin related compound F. ]
[Note—Use water that has a resistivity of NLT 18 Mohm-cm. ]
Mobile phase:
Proceed as directed in the Assay.
Solution A:
2.7 mg/mL of monobasic potassium phosphate in water. Adjust with 10 N potassium hydroxide to a pH of 7.5 ± 0.1.
Diluent:
Acetonitrile and Solution A (1:3)
Standard stock solution:
45 µg/mL of USP Desosaminylazithromycin RS, 105 µg/mL of USP N-Demethylazithromycin RS, and 160 µg/mL of USP Azithromycin RS in acetonitrile
Standard solution:
0.9 µg/mL of USP Desosaminylazithromycin RS, 2.1 µg/mL of USP N-Demethylazithromycin RS, and 3.2 µg/mL of USP Azithromycin RS from the Standard stock solution in Diluent
Sample solution:
33 mg of Azithromycin in a 100-mL volumetric flask. Add 5 mL of acetonitrile, and sonicate for about 20 s to dissolve. Dilute with Diluent to volume.
[Note—Use this solution within 6 h. ]
Chromatographic system
Mode:
LC
Detector:
Amperometric electrochemical detector
Detector type:
Dual glassy carbon electrodes
Detector mode:
Oxidative screen mode
Detector settings:
Electrode 1 set at +0.70 ± 0.05 V, electrode 2 set at +0.85 ± 0.05 V, background current optimized to 95 ± 25 nanoamperes
[Note—In general, maintain electrode 1 at 0.12 V less than electrode 2, and maintain the electrodes at a constant temperature of about 26. ]
. ]
Column
Guard column:
4.6-mm × 5-cm; 5-µm packing L29
Analytical column:
4.6-mm × 15-cm; 5-µm packing L29 or 3-µm packing L49 without the guard column.
Flow rate:
0.4 mL/min
Injection size:
50 µL
System suitability
Sample:
Standard solution
Suitability requirements
Column efficiency:
NLT 1500 theoretical plates for the azithromycin peak
Tailing factor:
NMT 1.5 for each peak
Relative standard deviation:
NMT 5% for each of these compounds
Analysis
Samples:
Standard solution and Sample solution
[Note—Record the Sample solution chromatograms for NLT 3.3 times the retention time of the azithromycin peak. ]
Calculate the percentages of desosaminylazithromycin and N-demethylazithromycin in the portion of Azithromycin taken:
Result = (rU/rS) × (CS/CU) × F × 100
| rU | = | = peak area for the relevant analyte from the Sample solution |
| rS | = | = peak area for the relevant analyte from the Standard solution |
| CS | = | = concentration of the appropriate USP Reference Standard in the Standard solution (µg/mL) |
| CU | = | = concentration of the Sample solution (mg/mL) |
| F | = | = unit conversion (0.001 mg/µg) |
Calculate the percentages of other related substances in the portion of Azithromycin taken:
Result = (rU/rS) × (CS/CU) × F × 100
| rU | = | = peak area of each additional impurity from the Sample solution |
| rS | = | = peak area of the azithromycin peak from the Standard solution |
| CS | = | = concentration of USP Azithromycin RS in the Standard solution (µg/mL) |
| CU | = | = concentration of the Sample solution (mg/mL) |
| F | = | = unit conversion (0.001 mg/µg) |
Acceptance criteria:
See Impurity Table 1.
Impurity Table 1
| Name | Relative Retention Time |
Acceptance Criteria, NMT (%) |
|---|---|---|
| Desosaminylazithromycin | 0.38 | 0.3 |
| N-demethylazithromycin | 0.54 | 0.7 |
| Total impurities | — | 3.0 |
• Procedure 2
[Note—Use Organic Impurities, Procedure 2 when the impurity profile includes azithromycin related compound F. ]
Solution A:
1.8 mg/mL of anhydrous dibasic sodium phosphate in water. Adjust with 1 N sodium hydroxide or 10% phosphoric acid to a pH of 8.9.
Solution B:
Acetonitrile and methanol (3:1)
Mobile phase:
See the gradient table below.
| Time (min) |
Solution A (%) |
Solution B (%) |
|---|---|---|
| 0 | 50 | 50 |
| 25 | 45 | 55 |
| 30 | 40 | 60 |
| 80 | 25 | 75 |
| 81 | 50 | 50 |
| 93 | 50 | 50 |
Solution C:
1.73 mg/mL of monobasic ammonium phosphate. Adjust with ammonia TS to a pH of 10.0 ± 0.05.
Solution D:
Methanol, acetonitrile, and Solution C (7:6:7)
System suitability solution:
0.0165 mg/mL of USP Azithromycin Related Compound F RS and 0.027 mg/mL of USP Desosaminylazithromycin RS in Solution D
Standard solution:
86 µg/mL of USP Azithromycin RS in Solution D
Sample solution:
8.6 mg/mL of Azithromycin in Solution D
Chromatographic system
Mode:
LC
Detector:
UV 210 nm
Column:
4.6-mm × 25-cm; 5-µm packing L1
Column temperature:
60
Flow rate:
1 mL/min
Injection size:
50 µL
System suitability
Samples:
System suitability solution and Standard solution
Suitability requirements
Peak-to-valley ratio:
NLT 1.4, System suitability solution
[Note—The calculation formula for peak-to-valley ratio is:
]
Result = HP/HV
| HP | = | = height above the baseline of the desosaminylazithromycin peak |
| HV | = | = height above the baseline of the lowest point of the curve separating the desosaminylazithromycin and azithromycin related compound F peaks. |
Tailing factor:
0.8–1.5, Standard solution
Analysis
Samples:
Standard solution and Sample solution
[Note—Disregard peaks eluting before azithromycin 3¢-N-oxide and after 3-deoxyazithromycin (azithromycin B). Disregard peaks with a response less than 0.1 times the response of the azithromycin peak in the Standard solution (0.1%). ]
Calculate the percentage of each related compound in the portion of Azithromycin taken:
Result = (rU/rS) × (CS/CU) × P × F1 × 100/F2
| rU | = | = peak response for each impurity from the Sample solution |
| rS | = | = peak response of azithromycin from the Standard solution |
| CS | = | = concentration of USP Azithromycin RS in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of azithromycin in the Sample solution (mg/mL) |
| F1 | = | = unit conversion factor (0.001 mg/µg) |
| F2 | = | = relative response factor (see Impurity Table 1) |
Acceptance criteria:
See Impurity Table 2.
Impurity Table 2
| Name | Relative Retention Time |
Relative Response Factor (F2) |
Acceptance Criteria, NMT (%) |
|---|---|---|---|
| Azithromycin N-oxidea | 0.29 | 0.43 | 0.5 |
| 3¢-(N,N-Didemethyl)-3¢-N-formylazithromycinb | 0.37 | 1.7 | 0.5 |
| 3¢-(N,N-Didemethyl) azithromycin (aminoazithromycin)c | 0.43 | 1.0 | 0.5 |
| Azithromycin related compound Fd | 0.51 | 3.8 | 0.5 |
| Desosaminylazithromycine | 0.54 | 1.0 | 0.3 |
| N-Demethylazithromycinf | 0.61 | 1.0 | 0.7 |
| Azithromycin C (3”-O-demethylazithromycin)g | 0.73 | 1.0 | 0.5 |
| 3¢-De(dimethylamino)-3¢-oxoazithromycinh | 0.76 | 1.5 | 0.5 |
| Azaerythromycin Ai | 0.83 | 1.0 | 0.5 |
| Azithromycin impurity Pj | 0.92 | 1.0 | 0.2 |
| Azithromycin | 1.0 | — | — |
| 2-Desethyl-2- propylazithromycink |
1.23 | 1.0 | 0.5 |
| 3¢-N-Demethyl-3¢-N-[(4-methylphenyl)sulfonyl]azithromycinl | 1.26 | 1.0 | 0.5 |
| 3-Deoxyazithromycin (azithromycin B)m | 1.31 | 1.0 | 1.0 |
| Any individual, unidentified impurity | — | 1.0 | 0.2 |
| Total impurities | — | — | 3.0 |
|
a
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylazinoyl)--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
b
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-formamido-3,4,6-trideoxy--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
c
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-amino-3,4,6-trideoxy--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
d
3¢-N-Demethyl-3¢-N-formylazithromycin.
e
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-Ethyl-3,4,10,13-tetrahydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-dimethylamino-
-d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
f
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-methylamino--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
g
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-dimethylamino--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
h
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3,3-dimethyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-oxo--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
i
9-Deoxo-9a-aza-9a-homoerythromycin A.
j
Specified unidentified impurity.
k
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-
-l-ribo-hexopyranosyl)oxy]-2-propyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one dihydrate.
l
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-[N-(4-methylphenylsulfonyl)-N-methylamino]-3,4,6-trideoxy--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
m
(2R,3R,4S,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-4,10-dihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
|
|||
SPECIFIC TESTS
• Optical Rotation, Specific Rotation 781S:
–45 to 
49, at 20
781S:
–45 to 49, at 20
Sample solution:
20 mg/mL, in dehydrated alcohol
• Crystallinity 695:
Meets the requirements except, where it is labeled as amorphous, most of the particles do not exhibit birefringence and extinction positions
695:
Meets the requirements except, where it is labeled as amorphous, most of the particles do not exhibit birefringence and extinction positions
• pH 791:
9.0–11.0
791:
9.0–11.0
Sample stock solution:
4 mg/mL in methanol
Sample solution:
2 mg/mL from the Sample stock solution in a mixture of methanol and water (1:1)
• Water Determination, Method I 921
921
Where it is labeled as anhydrous:
NMT 2.0%
Where it is labeled as the dihydrate:
4.0%–5.0%
Where it is labeled as the monohydrate:
1.8%–4.0%, except that it may be 4.0%–6.5% when the requirements of the Loss on Drying test are met
• Loss on Drying:
Where it is labeled as Azithromycin monohydrate and has a water content of 4.0%–6.5% (see Thermal Analysis 891).
891).
[Note—The quantity taken for this procedure may be adjusted, if necessary, for instrument sensitivity. ]
Analysis:
Determine the percentage of volatile substances by thermogravimetric analysis in an appropriately calibrated instrument, using about 10 mg of Azithromycin. Heat the specimen at the rate of 10/min between ambient temperature and 150 in an atmosphere of nitrogen at a constant flow rate of about 35 mL/min. From the thermogram plot the derivatives of the loss on drying (percent loss/min), identify the inflection points of the two weight loss steps at about 70 and 130.
/min between ambient temperature and 150 in an atmosphere of nitrogen at a constant flow rate of about 35 mL/min. From the thermogram plot the derivatives of the loss on drying (percent loss/min), identify the inflection points of the two weight loss steps at about 70 and 130.
Acceptance criteria:
It loses NMT 4.5% of its weight between ambient temperature and the inflection point at about 70, and 1.8%–2.6% between the inflection point at about 70 and the inflection point at about 130.
, and 1.8%–2.6% between the inflection point at about 70 and the inflection point at about 130.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
• Labeling:
Label it to indicate whether it is anhydrous, or the monohydrate or the dihydrate. The amorphous form is so labeled. Where the quantity of azithromycin is indicated in the labeling of any preparation containing Azithromycin, this shall be understood to be in terms of anhydrous azithromycin (C38H72N2O12). The labeling states with which Organic Impurities procedure the article complies, if other than Procedure 1.
• USP Reference Standards 11
11
USP Azithromycin RS 
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USP Azaerythromycin A RS
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USP Azithromycin Identity RS
A mixture of azithromycin, 3¢-(N-N-dimethyl-3¢-N-formyl-azithromycin, 3¢-N-demethyl-3¢-N-formylazithromycin (Rotamer 1), 3¢-N-demethyl-3¢-N-formylazithromycin (Rotamer 2), 3¢-de(dimethylamino)-3¢-oxoazithromycin, 2-desethyl-2-propylazithromycin, 3-deoxyazithromycin and 3¢-N-demethyl-3¢-N-[(4-methylphenyl)sulfonyl]azithromycin.
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A mixture of azithromycin, 3¢-(N-N-dimethyl-3¢-N-formyl-azithromycin, 3¢-N-demethyl-3¢-N-formylazithromycin (Rotamer 1), 3¢-N-demethyl-3¢-N-formylazithromycin (Rotamer 2), 3¢-de(dimethylamino)-3¢-oxoazithromycin, 2-desethyl-2-propylazithromycin, 3-deoxyazithromycin and 3¢-N-demethyl-3¢-N-[(4-methylphenyl)sulfonyl]azithromycin.
USP Desosaminylazithromycin RS
USP N-Demethylazithromycin RS
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl--l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-methylamino--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
C37H70N2O12 734.96
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-methylamino--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
C37H70N2O12 734.96
USP Azithromycin Related Compound F RS
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl--l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-(N-methyl)formamido-3,4,6-trideoxy--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
C38H70N2O13 762.97
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-
-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-(N-methyl)formamido-3,4,6-trideoxy--d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
C38H70N2O13 762.97
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ahalya Wise, M.S.
Senior Scientific Liaison 1-301-816-8161 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2279
Pharmacopeial Forum: Volume No. 36(1) Page 70