Description

Rac Adrenaline Impurity D CAS NO 1095714-91-2 is a critical reference standard used in the analytical profiling and quality control of adrenaline (epinephrine) and related pharmaceutical compounds. This impurity is essential for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) and finished drug products by enabling accurate identification and quantification. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and compliance testing for cardiovascular and emergency medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Adrenaline/Epinephrine APIs.
• Analytical Method Development: Used in HPLC, UPLC, and GC methods to establish impurity profiles, retention times, and calibration curves.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submissions (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of degradation products in adrenaline formulations under various stress conditions.
• Pharmacopoeial Testing: Supports testing in compliance with monographs from USP, EP, BP, and other international pharmacopoeias.
• Research & Development: Used in synthetic chemistry and process research to understand and minimize impurity formation during API manufacturing.

Basic Information

Product Name	Rac Adrenaline Impurity D
CAS No.	1095714-91-2
Molecular Formula	C9H11NO3
Molecular Weight	181.19 g/mol
Synonyms	rac-Epinephrine Impurity D; DL-Adrenaline Impurity D; (±)-Epinephrine Related Compound D; 1-(3,4-Dihydroxyphenyl)-2-(methylamino)ethanone; Adrenalone Impurity; Racemic Adrenaline Impurity D; Epinephrine Racemate Impurity D
EINECS	Contact for details

Quality Control

Every batch of Rac Adrenaline Impurity D is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. Certificates of Analysis (COA) providing detailed results for identity, purity, and assay are available upon request.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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