Description

Hyoscyamine Related Compound A (Norhyoscyamine Sulfate) is a high-purity analytical reference standard, essential for pharmaceutical quality control and research. This compound serves as a critical impurity marker for the anticholinergic drug Hyoscyamine, ensuring product safety and regulatory compliance. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and research institutions for method development, validation, and routine testing.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material for the identification and quantification of Norhyoscyamine in Hyoscyamine sulfate drug substances and finished products.
• Analytical Method Development & Validation: A critical component for developing and validating HPLC, UPLC, or GC methods to meet ICH Q3A/B guidelines for impurities.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for preparing calibration curves in routine pharmaceutical analysis.
• Pharmacological and Metabolic Studies: Utilized in research to study the metabolism, pharmacokinetics, and degradation pathways of tropane alkaloids.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing a characterized impurity standard for drug master files.
• Stability Testing: Employed to monitor the formation of degradation products in stability studies of Hyoscyamine-based formulations.

Basic Information

Item	Detail
Product Name	Hyoscyamine Related Compound A (Norhyoscyamine Sulfate)
CAS No.	537-29-1
Molecular Formula	C17H23NO3 · H2SO4
Molecular Weight	389.45 g/mol
Synonyms	Norhyoscyamine Sulfate; Tropine Tropate Sulfate; DL-Norhyoscyamine Sulfate; 3α-Hydroxy-8-methyl-8-azabicyclo[3.2.1]octane-2β-yl (S)-3-hydroxy-2-phenylpropanoate sulfate; Hyoscyamine Impurity A; Atropine Related Compound A; Tropine tropate (ester) sulfate salt
EINECS	Contact for details

Quality Control

Every batch of Hyoscyamine Related Compound A is manufactured and tested under strict quality management systems. The product is characterized using advanced analytical techniques including HPLC, NMR, and mass spectrometry to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results. Our quality standards align with the requirements for pharmaceutical reference standards.

Storage

Preserve in the original tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Avoid prolonged exposure to air.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.