Description

Bisoprolol Ep Impurity Q is a structurally defined reference standard and critical quality control material used in the analytical characterization of bisoprolol fumarate, a selective β1-adrenergic blocker widely prescribed for hypertension and chronic heart failure. This impurity serves as an essential tool for method validation, stability-indicating assay development, and regulatory compliance testing in pharmaceutical manufacturing and quality assurance laboratories. It is primarily required by API manufacturers, contract research organizations (CROs), and global pharmacopeial laboratories engaged in bisoprolol-related drug substance and product release testing. Bisoprolol Ep Impurity Q CAS NO 1346604-00-9 is supplied under strict quality-controlled conditions to ensure batch-to-batch consistency and traceability.

Application

• Pharmaceutical quality control for bisoprolol fumarate active pharmaceutical ingredient (API) release testing
• Reference standard for HPLC and UPLC method development and validation in stability studies
• Calibration and system suitability testing in regulatory submissions (FDA, EMA, PMDA, NMPA)
• Identification and quantification of epimeric impurities during ICH Q3A/Q5A-compliant impurity profiling
• Supporting root cause analysis of process-related impurities in bisoprolol synthesis
• Use in forced degradation studies to assess chromatographic resolution of stereoisomeric impurities
• Training and proficiency testing for analytical chemistry laboratories accredited to ISO/IEC 17025
• Reference material for pharmacopeial monograph compliance (EP 11.0, USP-NF)

Basic Information

Product Name	Bisoprolol Ep Impurity Q
CAS No.	1346604-00-9
Molecular Formula	C18H31NO4
Molecular Weight	325.44 g/mol
Synonyms	(2R,3S)-2-(Isopropylamino)-1-[4-[(2R,3R)-3-(tert-butoxycarbonylamino)-2-hydroxypropoxy]phenyl]propan-1-ol; Bisoprolol Epimer Q; Bisoprolol (2R,3S)-epimer; Bisoprolol EP Impurity Q; (2R,3S)-Bisoprolol; (2R,3S)-2-[(1-Methylethyl)amino]-1-[4-[(2R,3R)-3-[(1,1-dimethylethoxy)carbonylamino]-2-hydroxypropoxy]phenyl]propan-1-ol; BISOPROLOL EPIMERIC IMPURITY Q; Bisoprolol (2R,3S)-diastereomer
EINECS	Contact for details

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. Each batch is verified for identity, purity, and stereochemical integrity using orthogonal methods including HPLC with chiral separation, NMR spectroscopy, and high-resolution mass spectrometry (HRMS). All materials meet stringent requirements for pharmaceutical reference standards per ICH Q5A, USP <1225>, and EP 5.12 guidelines. Full traceability, stability data, and GMP-aligned documentation support global regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store at 2–8 °C under inert atmosphere (nitrogen or argon) to prevent degradation. Due to its hygroscopic nature, maintain low ambient humidity (<30% RH) and minimize exposure to air during handling.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Single impurity ≤ 0.3%; Total impurities ≤ 0.5%
Optical Rotation	[α]D20 = –12.5° to –14.5° (c = 1 in methanol)
Water Content (Karl Fischer)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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