Description

Carisoprodol Isopropyl Impurity is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Carisoprodol. This compound, with CAS No. 1729-14-2, is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing. The availability of a well-characterized impurity standard is essential for meeting stringent pharmacopeial requirements and maintaining supply chain integrity in drug production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the isopropyl impurity in Carisoprodol API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC, GC) for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure Carisoprodol batches comply with specified impurity limits as per ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, DMF) by providing necessary impurity data for health authority submissions.
• Research & Development: Used in R&D to study the synthesis pathway, degradation mechanisms, and purification processes of Carisoprodol.

Basic Information

Product Name	Carisoprodol Isopropyl Impurity
CAS No.	1729-14-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Isopropyl Impurity of Carisoprodol; Carisoprodol Related Compound; 2-[(Isopropylcarbamoyl)oxy]-4-methylpentane; N-Isopropylcarbamic acid 2-methyl-2-propyl-1,3-propanediyl ester (isomeric form); Carisoprodol Process Impurity; Carisoprodol Isomer; Soma Impurity
EINECS	Contact for details

Quality Control

Our Carisoprodol Isopropyl Impurity is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for identity, purity, and impurities. Our quality commitment aligns with ICH guidelines and supports compliance in cGMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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