Description

Std1T CAS NO 893075-58-6 is a high-purity chemical reference standard, also known as a certified reference material (CRM), essential for analytical method validation and quality assurance. This compound is critical for ensuring the accuracy, precision, and traceability of measurements in regulated laboratory environments. It is primarily required by pharmaceutical R&D, quality control laboratories, and contract research organizations (CROs) for applications such as impurity profiling, assay development, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Identification and Quantification: Used as a primary standard to identify and quantify related substances and degradation products in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to meet ICH Q2(R1) guidelines.
• Quality Control and Batch Release Testing: Provides the benchmark for routine quality control testing to ensure drug substance and drug product specifications are met consistently.
• Stability Studies: Employed as a reference in forced degradation and long-term stability studies to monitor the formation of impurities over time.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing documented evidence of analytical procedure suitability and control strategy.
• Calibration of Laboratory Equipment: Used to calibrate and qualify analytical instruments, ensuring measurement system accuracy and reliability.

Basic Information

Product Name	Std1T
CAS No.	893075-58-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Std1T; 893075-58-6; (Provide specific IUPAC name upon request); Pharmaceutical Reference Standard; Certified Reference Material (CRM); Analytical Standard; Chemical Reference Substance; Pharmacopeial Standard.
EINECS	Contact for details

Quality Control

Every batch of Std1T is produced and certified under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and stability testing to ensure compliance with relevant pharmacopeial standards (e.g., USP, EP, JP) and ICH guidelines. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, traceability, and storage recommendations, is provided with each unit and is available upon request.

Storage

Preserve in the original tightly closed container, protected from light and moisture. Store at the temperature specified on the label or Certificate of Analysis, typically at controlled room temperature (15-25°C) or under refrigeration (2-8°C) as required. Keep the container sealed in a dry environment to maintain stability and certified purity throughout its shelf life.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 99.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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