Description

Salmeterol Xinafoate Adduct Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products containing Salmeterol Xinafoate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for meeting stringent regulatory compliance in drug development and manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Salmeterol Xinafoate drug substance and finished dosage forms.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles in accordance with ICH Q3A and Q3B guidelines.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch release testing in GMP environments to ensure product purity and consistency.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the fate of related substances in biological systems.

Basic Information

Product Name	Salmeterol Xinafoate Adduct Impurity
CAS No.	1330076-52-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Salmeterol Xinafoate Related Compound; Salmeterol Impurity; Salmeterol Xinafoate Adduct; 1-Hydroxy-2-naphthoic acid compound with 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol (1:1) adduct impurity; Salmeterol 1-Hydroxy-2-naphthoate Adduct Impurity
EINECS	Contact for details

Quality Control

Every batch of Salmeterol Xinafoate Adduct Impurity is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency in line with current industry and pharmacopeial expectations. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical quality attributes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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