Description

Tilidine Impurity D Hydrochloride is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of related substances in Tilidine API and finished drug products, ensuring product safety and regulatory compliance. It is primarily used by analytical laboratories, quality control units, and R&D departments within the pharmaceutical and fine chemical industries to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Tilidine hydrochloride.
• Analytical Research: Used in HPLC, UPLC, and GC methods for the precise identification and quantification of process-related impurities and degradation products.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity profiling.
• Stability Studies: Employed to monitor impurity formation in drug substance and drug product stability programs under ICH guidelines.
• Method Transfer & Verification: Acts as a system suitability component when transferring analytical methods between laboratories or sites.
• Pharmacopeial Testing: Supports testing to comply with monographs from USP, EP, or other international pharmacopeias.

Basic Information

Product Name	Tilidine Impurity D Hydrochloride
CAS No.	24811-92-5
Molecular Formula	C₁₇H₂₅NO₂ • HCl
Molecular Weight	311.85 g/mol (free base: 275.38 g/mol)
Synonyms	1-(Cyclohexylmethyl)-4-(dimethylamino)-1,2,3,4-tetrahydro-6-methyl-2,3-naphthalenediol Hydrochloride; Tilidine Related Compound D HCl; Tilidine EP Impurity D HCl; Tilidine USP Impurity D Hydrochloride; Tilidine Hydrochloride Impurity D; (1R,2R)-rel-1-[(Cyclohexylmethyl)amino]-4-(dimethylamino)-2,3-dihydro-2-methyl-1H-2-benzoxepin-5-ol Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Tilidine Impurity D Hydrochloride is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic and spectroscopic methods, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for all critical quality attributes. We support compliance with cGMP, ICH Q3A/B, and relevant pharmacopeial 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 light-sensitive; therefore, containers must be kept tightly sealed in a desiccated environment and handled under appropriate conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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