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Norepinephrine Tartrate Impurity G CAS NO 13062-58-3
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CAS No.:13062-58-3
Grade:Pharmacy Grade
Content:99.9%
Brand:Customizable
Packaging:Customizable
Description
Norepinephrine Tartrate Impurity G is a specified impurity of the active pharmaceutical ingredient Norepinephrine Tartrate, a critical sympathomimetic agent. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Norepinephrine Tartrate drug substances and products.
Application
- Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Norepinephrine Tartrate API.
- Critical component in analytical method development and validation (e.g., HPLC, UPLC) for pharmaceutical quality control laboratories.
- Used in stability studies to monitor degradation pathways and establish shelf-life for Norepinephrine Tartrate formulations.
- Essential for regulatory compliance and submission, providing necessary impurity profiles for FDA, EMA, and other health authority filings.
- Supports pharmacopoeial testing in accordance with standards set by USP, EP, and other international pharmacopoeias.
- Utilized in research and development to understand the synthesis pathways and degradation mechanisms of Norepinephrine Tartrate.
Basic Information
| Product Name | Norepinephrine Tartrate Impurity G |
| CAS No. | 13062-58-3 |
| Molecular Formula | Contact for details |
| Molecular Weight | Contact for details |
| Synonyms | Noradrenaline Tartrate Impurity G; L-Norepinephrine Tartrate Impurity G; (R)-4-(2-Amino-1-hydroxyethyl)benzene-1,2-diol tartrate impurity G; 1,2-Benzenediol, 4-[(1R)-2-amino-1-hydroxyethyl]-, (2R,3R)-2,3-dihydroxybutanedioate (1:1) salt; Norepinephrine Bitartrate Related Compound G; EP Impurity G of Norepinephrine Tartrate; USP Related Substance G of Norepinephrine Tartrate |
| EINECS | Contact for details |
Quality Control
Our Norepinephrine Tartrate Impurity G is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. Certificates of Analysis (COA) are provided, detailing comprehensive specifications and confirming compliance with relevant pharmacopoeial standards (e.g., USP, EP) for use as a reference material.
Storage
Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled under appropriate conditions to prevent degradation.
Specification
| Item | Specification |
|---|---|
| Appearance | White to off-white powder |
| Identification (IR) | Conforms to structure |
| Identification (HPLC) | Retention time matches reference |
| Purity (HPLC) | ≥ 95.0% |
| Related Substances (HPLC) | Meets requirement |
| 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.
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