Catégorie
Naloxone
Numéro CAS
Naloxone STD-465-65-6; 357-08-4(HCl Salt);51481-60-8(HCl Dihydrate): IMP-A-33522-95-1; 52446-24-9 (HCl salt) ; 2162130-71-2 (H2O): IMP-B-1352085-46-1; 2139253-87-3(HCl Salt): IMP-C-2139253-68-0: IMP-D-26451-92-3: IMP-E-211738-08-8: IMP-F-2139253-69-1
Formule moléculaire
Naloxone STD-C19H21NO4: IMP-A-C16H17NO4: IMP-B-C22H25NO4: IMP-C-C19H21NO5: IMP-D-C19H19NO4: IMP-E-C36H32N2O8: IMP-F-C19H21NO5
Masse moléculaire
Naloxone STD-327.37: IMP-A-287.3: IMP-B-367.44: IMP-C-343.37: IMP-D-325.36: IMP-E-652.7: IMP-F-343.37
Synonyme

Naloxone STD-(4R,4aS,7aR,12bS)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one; (4R,4aS,7aR,12bS)-3-Allyl-4a,9-dihydroxy-2,3,4,4a,5,6-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7(7aH)-one; (1S,5R,13R,17S)-10,17-dihydroxy-4-(prop-2-en-1-yl)-12-oxa-4-azapentacyclo [9.6.1.01,13.05,17.07,18]octadeca-7(18),8,10-trien- 14-one; 17-allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one (USP)

Naloxone-EP-Impurity-A-(4R,4aS,7aR,12bS)-4a,9-dihydroxy-1,2,3,4,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one

Naloxone-EP-Impurity-B-(4R,4aS,7aR,12bS)-4a-hydroxy-9-prop-2-enoxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one

Naloxone-EP-Impurity-C-(4R,4aS,7aR,12bS,13S)-4a,9,13-trihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one

Naloxone-EP-Impurity-D-(4R,4aS,7aR,12bS)-4a,9-dihydroxy-3-prop-2-enyl-2,4,7a,13-tetrahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one

Naloxone-EP-Impurity-E-(4R,4aS,7aR,12bS)-10-[(4R,4aS,7aR,12bS)-4a,9-dihydroxy-7-oxo-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-10-yl]-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one

Naloxone-EP-Impurity-F-(4R,4aS,7aR,12bS,13R)-4a,9,13-trihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one

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.

In the context of chromatographic analysis, Naloxone CRS (Chemical Reference Substance) is used as a validated reference standard to confirm the identity and purity of naloxone in pharmaceutical testing. During methods such as HPLC, the CRS provides a benchmark retention time and peak profile, allowing analysts to match the sample’s peak with the standardized naloxone peak to ensure accurate peak identification, method calibration, and compliance with pharmacopeial requirements (e.g., Ph. Eur., USP).