Category
Budesonide
CAS Number
Budesonide STD - 51333-22-3 ;IMP- A-13951-70-7 ;IMP -D-85234-63-5 ; IMP- G-137174-25-5 ; IMP- K - 51333-05-2 ; IMP- L - 216453-74-6 ;Budesonide epimer A - 51372-28-2 ; Budesonide epimer B - 51372-29-3 ;
Molecular Formula
Budesonide STD -C₂₅H₃₄O₆ ;IMP- A - C₂₁H₂₈O₆ ;IMP- D- C₂₅H₃₂O₆ ; IMP- G-C₂₅H₃₆O₆ ; IMP- K - C₂₇H₃₆O₇ ; IMP- L - C₂₅H₃₂O₆ ;Budesonide epimer A - C₂₅H₃₄O₆ ; Budesonide epimer B - C₂₅H₃₄O₆  ;
Molecular Weight
Budesonide STD - 430.53 ;IMP- A - 376.4 ;IMP- D-428.52 ; IMP- G- 432.55 ; IMP- K - 472.57 ; IMP- L - 428.5 ; Budesonide epimer A - 430.53 ; Budesonide epimer B - 430.53  ;
Synonym

Budesonide STD - (11beta,16alpha)-16,17-[Butylidenebis(oxy)]-11,21-dihydroxypregna-1,4-diene-3,20-dione;Bidien; Budenofalk; Budesomide; Budeson; Cortivent; Entocort; Micronyl; Nebuampul; Preferid; Pulmicort; Respules; Rhinocort; Rhinocort Aqua;

Budesonide - EP - IMP- A - 11beta,16alpha,17,21-Tetrahydroxypregna-1,4-diene-3,20-dione ; 

Budesonide - EP - IMP- D - 16α,17-[(1RS)-Butylidenebis(oxy)]-11β-hydroxy-3,20-dioxopregna-1,4-dien-21-aldehyde ;Budesonide Glyoxal (Epimers); 16,17-[Butylidenebis(oxy)]-11-hydroxy-3,20-dioxopregna-1,4-dien-21-al (USP); Budesonide glyoxal (epimer A & B);

Budesonide - EP - IMP- G -  16α,17-[(1RS)-Butylidenebis(oxy)]-11β,21-dihydroxypregn-4-ene-3,20-dione; (6aR,6bS,7S,8aS,8bS,11aR,12aS,12bS)-7-hydroxy-8b-(2-hydroxyacetyl)-6a,8a-dimethyl-10-propyl-1,2,5,6,6a,6b,7,8,8a,8b,11a,12,12a,12b-tetradecahydro-4H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-4-one;

Budesonide - EP - IMP- K - 16 alpha,17-[Butylidenebis(oxy)]-11beta,21-dihydroxypregna-1,4-diene-3,20-dione-21-Acetate ; Budesonide 21-Acetate (Epimers) ; 

Budesonide - EP - IMP- L - 16alpha,17-[Butylidenebis(oxy)]-21-hydroxypregna-1,4-diene-3,11,20-trione;

Budesonide epimer A - (22S)-Budesonide ; Pregna-1,4-diene-3,20-dione, 16alpha,17-[(1S)-butylidenebis(oxy)]-11beta,21-dihydroxy- ;(6aR,6bS,7S,8aS,8bS,10S,11aR,12aS,12bS)-7-Hydroxy-8b-(2-hydroxyacetyl)-6a,8a-dimethyl-10-propyl-1,2,6a,6b,7,8,8a,8b,11a,12,12a,12b-dodecahydro-4H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-4-one; Budesonide epimer A IP Impurity;

Budesonide epimer B - (22R)-Budesonide; Dexbudesonide; Pregna-1,4-diene-3,20-dione, 16α,17-[(1R)-butylidenebis(oxy)]-11β,21-dihydroxy-; (6aR,6bS,7S,8aS,8bS,10R,11aR,12aS,12bS)-7-hydroxy-8b-(2-hydroxyacetyl)-6a,8a-dimethyl-10-propyl-1,2,6a,6b,7,8,8a,8b,11a,12,12a,12b-dodecahydro-4H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-4-one; Budesonide epimer B IP Impurity ; 

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.

Budesonide system suitability CRS (Chemical Reference Substance) is used as a standard to verify the performance and reliability of analytical methods, especially in chromatographic analysis, ensuring that parameters such as resolution, peak symmetry, and repeatability meet predefined acceptance criteria before sample testing; it also confirms that the analytical system is functioning properly and producing accurate, consistent results for the determination of budesonide in pharmaceutical preparations.