Category
Biotin
CAS Number
Biotin Standard-58-85-5: IMP-A- 1163708-46-0:IMP-C-22342-46-7:IMP-E-NA :
Molecular Formula
Biotin Standard-C10H16N2O3S: IMP-A- C18H28N4O4S2 :IMP-C-C9H18N2O2S:IMP-E-C34H44N4O6S2 :
Molecular Weight
Biotin Standard- 244.31g/mol : IMP-A- 428.6 g/mol :IMP-C-218.32g/mol:IMP-E-668.9 g/mol :
Synonym

Biotin - (3aS,4S,6aR)-Hexahydro-2-oxo-1H-thieno[3,4-d]imidazole-4-pentanoic Acid; 5-((3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)pentanoic acid; 5-((3AR,6S,6AS)-2-OXO-HEXAHYDRO-THIENO[3,4-D]IMIDAZOL-6-YL)-PENTANOIC ACID;

Biotin EP Impurity A- 5-[(3aS,4S,6aR)-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl]-2-[[(3aS,4S,6aR)-2-oxohexahydro-1Hthieno[3,4-d]imidazol-4-yl]propyl]pentanoic acid;D-Biotin Dimer Acid ;

Biotin EP Impurity C - 5-[(2S,3S,4R)-3,4-diaminothiolan-2-yl]pentanoic acid; Diamino Biotin;Diaminobiotin;

Biotin EP Impurity E - 5-[(3aS,4S,6aR)-3-benzyl-2-oxo-3a,4,6,6a-tetrahydro-1H-thieno[3,4-d]imidazol-4-yl]pentanoic acid,5-[(3aR,6S,6aS)-3-benzyl-2-oxo-3a,4,6,6a-tetrahydro-1H-thieno[3,4-d]imidazol-6-yl]pentanoic acid ; Mixture of N1-Benzyl Biotin and N3-Benzyl Biotin;

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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.

Biotin System Suitability CRS is used as a reference standard to verify the performance and reliability of analytical systems in the testing of biotin-containing formulations. It supports method validation, system suitability testing, and ensures compliance with pharmacopeial and regulatory requirements.