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Ticarcillin Impurity A CAS NO 6933-26-2
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CAS No.:6933-26-2
Grade:Pharmacy Grade
Content:99.9%
Brand:Customizable
Packaging:Customizable
Description
Ticarcillin Impurity A CAS NO 6933-26-2 is a critical reference standard used in the pharmaceutical quality control process. This compound is essential for the accurate identification, quantification, and monitoring of impurities in Ticarcillin, a β-lactam antibiotic. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards. Utilizing this high-purity impurity standard is fundamental for method validation, stability studies, and batch release testing.
Application
- Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Ticarcillin API and finished drug products.
- Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component in developing and validating chromatographic methods for impurity profiling.
- Stability Studies: Employed to identify and track the formation of this specific degradant in Ticarcillin under various stress conditions (e.g., heat, humidity, light).
- Regulatory Compliance & Documentation: Essential for generating impurity data to meet the requirements of regulatory submissions to agencies like the FDA, EMA, and others.
- Pharmacopeial Testing: Used in testing to comply with monographs from USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international pharmacopeias.
- Research & Development: Utilized in R&D to study the degradation pathways and chemical behavior of Ticarcillin.
Basic Information
| Item | Detail |
|---|---|
| Product Name | Ticarcillin Impurity A |
| CAS No. | 6933-26-2 |
| Molecular Formula | C15H16N2O6S2 |
| Molecular Weight | 384.43 g/mol |
| Synonyms | (2S,5R,6R)-3,3-Dimethyl-7-oxo-6-[(2-thiophen-2-ylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; 6-[(Carboxy-2-thienylacetyl)amino]penicillanic acid; Ticarcillin Related Compound A; Ticarcillin Degradant; Ticarcillin EP Impurity A; Ticarcillin USP Impurity A |
| EINECS | Contact for details |
Quality Control
Every batch of Ticarcillin Impurity A is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including HPLC purity assay, identification by IR and HPLC comparison, and control of related substances and residual solvents, to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.
Storage
Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.
Specification
| Item | Specification |
|---|---|
| Appearance | White to off-white powder |
| Identification (IR) | Conforms to reference standard |
| Identification (HPLC) | Retention time corresponds to reference |
| Purity (HPLC) | ≥ 98.0% |
| Related Substances (HPLC) | Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5% |
| Water Content (KF) | ≤ 1.0% |
| Residual Solvents (GC) | Complies with ICH Q3C guidelines |
Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.
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