Hyoscine Butylbromide Impurity Standards

Hyoscine Butylbromide impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Hyoscine Butylbromide-related impurities during analytical method development, method validation, and regulatory filing. As a antispasmodic (Scopolamine Butylbromide), Hyoscine Butylbromide requires precise characterisation of its process impurities, degradation products, and related substances to meet European Pharmacopoeia (EP), United States Pharmacopeia (USP), and British Pharmacopoeia (BP) monograph requirements. Allmpus Laboratories manufactures and supplies a comprehensive library of Hyoscine Butylbromide impurity standards, each provided with a Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS). All products are held in-stock for rapid dispatch and are suitable for use in ANDA and DMF regulatory submissions.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Hyoscine Butylbromide

Chemical Name: (1R,2R,4S,5S,7s,9r)-9-Butyl-7-[[(2S)-3-h...

CAS No:
149-64-4

Molecular Formula: C21H30BrNO4

Molecular Weight: 440.37

CAT No:
ALL-HYB-644

Keywords: Hyoscine Butylbromide

Inventory Status:IN STOCK

COA MSDS

Hyoscine Butylbromide EP Impurity A

Chemical Name: (1R,2R,4S,5S,7S)-9-Methyl-3-oxa-9-azatri...

CAS No:
6533-68-2

Molecular Formula: C17H28BrNO7

Molecular Weight: 438.31

CAT No:
ALL-HYB-682

Keywords: Hyoscine Butylbromide EP Impurity A

Inventory Status:IN STOCK

COA MSDS

Hyoscine Butylbromide EP Impurity B

Chemical Name: α-(Hydroxymethyl)benzeneacetic acid

CAS No:
552-63-6

Molecular Formula: C9H10O3

Molecular Weight: 166.17

CAT No:
ALL-HYB-636

Keywords: Hyoscine Butylbromide EP Impurity B

Inventory Status:IN STOCK

COA MSDS

Hyoscine Butylbromide EP Impurity C

Chemical Name: (1R,2R,4S,5S,7s)-7-[[(2S)-3-Hydroxy-2-ph...

CAS No:
155-41-9

Molecular Formula: C18H24BrNO4

Molecular Weight: 398.29

CAT No:
ALL-HYB-419

Keywords: Hyoscine Butylbromide EP Impurity C

Inventory Status:IN STOCK

COA MSDS

Hyoscine Butylbromide EP Impurity D

Chemical Name: (1R,2R,4S,5S,7s,9r)-7-[[(2S)-3-Hydroxy-2...

CAS No:
N.A.

Molecular Formula: C20H28BrNO4

Molecular Weight: 426.34

CAT No:
ALL-HYB-001

Keywords: Hyoscine Butylbromide EP Impurity D

Inventory Status:IN STOCK

COA MSDS

Hyoscine Butylbromide EP Impurity E

Chemical Name: (1R,2R,4S,5S,7s)-9-Butyl-3-oxa-9-azatric...

CAS No:
22235-98-9

Molecular Formula: C20H28ClNO4

Molecular Weight: 381.89

CAT No:
ALL-HYB-989

Keywords: Hyoscine Butylbromide EP Impurity E

Inventory Status:IN STOCK

COA MSDS

Hyoscine Butylbromide EP Impurity F

Chemical Name: (1R,2R,4S,5S,7s,9s)-9-Butyl-7-[[(2S)-3-h...

CAS No:
N.A.

Molecular Formula: C21H30BrNO4

Molecular Weight: 440.37

CAT No:
ALL-HYB-002

Keywords: Hyoscine Butylbromide EP Impurity F

Inventory Status:IN STOCK

COA MSDS

Hyoscine Butylbromide EP Impurity G

Chemical Name: (1R,2R,4S,5S,7s,9r)-9-Butyl-9-methyl-7-[...

CAS No:
92714-23-3

Molecular Formula: C21H28BrNO3

Molecular Weight: 422.36

CAT No:
ALL-HYB-233

Keywords: Hyoscine Butylbromide EP Impurity G

Inventory Status:IN STOCK

COA MSDS

Key Impurity Variants Available

Hyoscine Butylbromide EP Impurity A (Hyoscine) — CAS 51-34-3, the parent tertiary amine formed by loss of the N-butyl group
Hyoscine Butylbromide EP Impurity B (Tropic Acid) — CAS 552-63-6, a hydrolysis product formed by ester cleavage
Hyoscine Butylbromide EP Impurity C — CAS 155-41-9, a related tropanium ester impurity
Hyoscine Butylbromide EP Impurity D (Hyoscine Propyl Impurity) — an N-propyl homolog arising from process-related alkylation variance
Hyoscine Butylbromide EP Impurity E (N — Butylhyoscine)-CAS 14861-14-4, a closely related quaternary structural isomer

Allmpus Capability for This Drug Family

Tropane alkaloid impurities present specific synthetic and analytical challenges due to their bicyclic ring stereochemistry, quaternary nitrogen centers, and the structural overlap between hyoscine butylbromide and its related compounds-hyoscine, hyoscyamine, ipratropium, and tropicamide-several of which share identical or closely related impurities. Allmpus Laboratories' synthetic and analytical chemistry teams operate within R&D and manufacturing facilities accredited by USFDA, EU GMP, EDQM, KFDA, and COFEPRIS, supporting the isolation, synthesis, and structural characterization of alkaloid-class impurities of this type. Standards are intended to be supplied with supporting analytical data-HPLC purity, NMR, and mass spectral confirmation-for direct use in method development, forced-degradation studies, and regulatory documentation. Where a specific EP-listed impurity is not currently in inventory, our teams can undertake custom synthesis on request, including cross-referenced impurities shared with related tropane alkaloid APIs.

Frequently Asked Questions

What supporting data comes with Allmpus hyoscine butylbromide impurity standards?

Standards are intended to be supplied with a Certificate of Analysis and supporting structural data, typically HPLC purity and spectroscopic confirmation, suitable for method validation and regulatory submissions.

Can Allmpus produce impurities shared across hyoscine, hyoscyamine, and related tropane alkaloids?

Yes. Given the structural overlap between hyoscine butylbromide and related tropane alkaloid APIs, our synthetic chemistry team can address cross-listed impurities on a case-by-case basis.

Are these standards intended for use in finished hyoscine butylbromide drug products?

No. Allmpus impurity standards are supplied strictly for laboratory, research, and analytical use-including method development and stability-indicating assay validation-and are not intended for human consumption or clinical administration.