Description

Nebivolol Impurity 13 Hcl (Ss,Ss) CAS NO 920275-27-0 is a high-purity chemical reference standard specifically used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the cardiovascular drug Nebivolol by accurately identifying and quantifying this specific stereoisomeric impurity. It is an essential material for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and production. The availability of this well-characterized impurity supports robust method validation and adherence to stringent ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Nebivolol Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor process-related impurities.
• Quality Control and Batch Release Testing: Used in routine QC laboratories to ensure that Nebivolol batches meet the specified impurity limits as per pharmacopeial monographs or internal specifications.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Research and Process Chemistry: Used by synthetic chemists to understand and optimize the manufacturing process of Nebivolol to minimize the formation of this impurity.

Basic Information

Product Name	Nebivolol Impurity 13 Hcl (Ss,Ss)
CAS No.	920275-27-0
Molecular Formula	C22H26F2NO4 • HCl
Molecular Weight	443.90 g/mol (Free base: 406.45 g/mol)
Synonyms	Nebivolol Related Compound H; (SS,SS)-Nebivolol Impurity 13 Hydrochloride; 1-(6-Fluorochroman-2-yl)-2-[[2-(6-fluorochroman-2-yl)-2-hydroxy-1-methylethyl]amino]ethanol hydrochloride (SS,SS-isomer); UNII-6J3V385P6F; Nebivolol EP Impurity H HCl; Nebivolol Diastereomer Impurity; (2R*,1'S*,2'S*)-1,1'-[iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanol] hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Nebivolol Impurity 13 Hcl (Ss,Ss) is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing to ensure identity, purity, and strength, aligning with current pharmacopeial expectations (USP, EP) and ICH Q3A/B guidelines for impurities. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results from tests including HPLC purity, chiral purity, residual solvents, and identity confirmation (IR, MS). Our quality commitment ensures this reference standard meets the exacting needs of pharmaceutical analysis.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0% (Ss,Ss isomer)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Assay (on dried basis)	97.0% - 103.0%

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