Description

Ticarcillin Sodium Impurity A CAS NO 36041-93-7 is a high-purity reference standard used for the identification and quantification of a key process-related impurity in Ticarcillin Sodium, a β-lactam antibiotic. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products. It is primarily required by analytical laboratories, quality control departments, and research institutions within the pharmaceutical and biotechnology sectors for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Ticarcillin Sodium.
• Impurity Profiling & Identification: Used in HPLC, UPLC, and LC-MS methods to identify and quantify Impurity A in active pharmaceutical ingredient (API) batches.
• Method Development & Validation: Essential for developing, validating, and transferring analytical methods in compliance with ICH Q2(R1) and pharmacopeial guidelines.
• Stability Indicating Studies: Employed to monitor the formation of this specific degradation product during forced degradation and long-term stability studies of Ticarcillin Sodium.
• Quality Control & Batch Release: A critical tool for in-process testing and final release testing of Ticarcillin Sodium API to ensure it meets stringent impurity limits.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.

Basic Information

Product Name	Ticarcillin Sodium Impurity A
CAS No.	36041-93-7
Molecular Formula	C15H14N2O6S2
Molecular Weight	390.41 g/mol
Synonyms	(2S,5R,6R)-3,3-Dimethyl-7-oxo-6-[(2R)-2-carboxy-2-thiophen-3-ylacetyl]amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; 6-[D(-)-α-(3-Thienyl)malonamido]penicillanic acid; Ticarcillin Related Compound A; Ticarcillin Acid; Ticarcillin Free Acid; Ticarcillin Impurity A; Ticarcillin EP Impurity A
EINECS	Contact for details

Quality Control

Our Ticarcillin Sodium Impurity A is manufactured under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques including NMR, MS, and HPLC against a certified reference standard. We provide comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles to support your regulatory needs. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH guidelines.

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 product is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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