Category
Fusidic Acid
CAS Number
Fusidic acid - 6990-06-3 ; IMP-A- 80445-74-5 ; IMP-B- NA ; IMP-C- NA; IMP-D- 3054708-76-5 ; IMP-F- 1415035-94-7; IMP-G- 4680-37-9; IMP-H- 16711-91-4 ;
Molecular Formula
Fusidic acid - C31H48O6; IMP-A- C31H50O8 ; IMP-B- C31H48O7 ; IMP-C- C31H48O7 ; IMP-D- ; IMP-F- C31H46O7; IMP-G- C31H46O6 ; IMP-H- C31H46O6;
Molecular Weight
Fusidic acid - 516.71 ; IMP-A- 550.72; IMP-B- 532.71 g/mol ; IMP-C- 532.71 ; IMP-D- 532.71 g/mol ; IMP-F- 530.69 g/mol ; IMP-G- 514.69 g/mol ; IMP-H- 514.7 g/mol ;
Synonym

Fusidic acid - (3alpha,4alpha,8alpha,9beta,11alpha,13alpha,147beta,167beta,17Z)-16-(Acetyloxy)-3,11-dihydroxy-29-nordammara-17(20),24-dien-21-oic Acid

Fusidic acid EP Impurity A - (3α,4α,8α,9β,11α,13α,14β,16β,17Z)-16-(Acetyloxy)-3,11,24,25-tetrahydroxy-29-nordammar-17(20)-en-21-oic Acid; 24,25-Dihydroxyfusidic Acid; 24,25-dihydroxyfusidic Acid;

Fusidic acid EP Impurity B - (3R,4S,5S,8S,9S,10S,11R,13R,14S,16S,Z)-3,11-Dihydroxy-17-((R)-6-hydroxy-7,7-dimethyl-2-oxooxepan-3-ylidene)-4,8,10,14-tetramethylhexadecahydro-1H-cyclopenta[a]phenanthren-16-yl Acetate;ent-(17Z)-3β,11β-Dihydroxy-17-[(6SR)-6-hydroxy-7,7-dimethyl-2-oxooxepan-3- ylidene]-4β,8,14-trimethyl-18-nor-5β,10α-androstan-16α-yl Acetate;

Fusidic acid EP Impurity C - (3R,4S,5S,8S,9S,10S,11R,13R,14S,16S,Z)-3,11-Dihydroxy-17-((R)-6-(2-hydroxypropan-2-yl)-2-oxodihydro-2H-pyran-3(4H)-ylidene)-4,8,10,14-tetramethylhexadecahydro-1H-cyclopenta[a]phenanthren-16-yl Acetate

Fusidic acid EP Impurity D - (3R,4S,5S,8S,9S,10S,11R,13R,14S,16S,Z)-3,11-Dihydroxy-17-((S)-6-(2-hydroxypropan-2-yl)-2-oxodihydro-2H-pyran-3(4H)-ylidene)-4,8,10,14-tetramethylhexadecahydro-1H-cyclopenta[a]phenanthren-16-yl Acetate ; ent-(17Z)-3beta,11beta-Dihydroxy-17-[(6R)-6-(1-hydroxy-1-methylethyl)-2-oxodihydro-2H-pyran-3(4H)-ylidene]-4beta,8,14-trimethyl-18-nor-5beta,10alpha-androstan-16alpha-yl acetate;(24S)-24,25-Dihydro-24,25-dihydroxyfusidic acid 21,24-lactone; Fusidic Acid Impurity D;

Fusidic acid EP Impurity F - 26-Oxofusidic Acid;(2Z,5E)-2-((3R,4S,5S,8S,9S,10S,11R,13R,14S,16S)-16-acetoxy-3,11-dihydroxy-4,8,10,14-tetramethyldodecahydro-1H-cyclopenta[a]phenanthren-17(2H,10H,14H)-ylidene)-6-methyl-7-oxohept-5-enoic acid; Ent-(17Z,24EZ)-16alpha-(acetyloxy)-3beta,11beta-dihydroxy-4beta,8,14-trimethyl-26-oxo-18-nor-5beta,10alpha-cholesta-17(20),24-dien-21-oic acid;

Fusidic acid EP Impurity G - (4alpha,8alpha,9beta,11alpha,13alpha,14beta,16beta,17Z)-16-(Acetyloxy)-11-hydroxy-3-oxo-29-nordammara-17(20),24-dien-21-oic Acid; Ent-(17Z)-16α-(acetyloxy)-11β-hydroxy-4β,8,14-trimethyl-3-oxo-18-nor-5β,10α-cholesta-17(20),24-dien-21-oic acid;

Fusidic acid EP Impurity H - (3alpha,4alpha,8alpha,9beta,13alpha,14beta,16beta,17Z)-16-(Acetyloxy)-3-hydroxy-11-oxo-29-nordammara-17(20),24-dien-21-oic acid; Ent-(17Z)-16α-(acetyloxy)-3β-hydroxy-4β,8,14-trimethyl-11-oxo-18-nor-5β,10α-cholesta-17(20),24-dien-21-oic acid;

Slide_1
Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Fusidic acid CRS is used as a chemical reference standard for peak identification in chromatographic analysis to confirm the presence of fusidic acid in pharmaceutical preparations. It ensures accurate identification, specificity, and compliance with pharmacopeial quality control requirements.