Description

δ-4-Tibolone D5 is a deuterated analog of the synthetic steroid tibolone, serving as a high-purity internal standard for precise analytical quantification. This compound is critical for ensuring accuracy and reliability in mass spectrometry-based methods, particularly in pharmacokinetic and metabolic studies. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in bioanalytical method development and quality control.

Application

• Internal Standard for LC-MS/MS: Used as a deuterated internal standard for the accurate quantification of tibolone and its metabolites in biological matrices (e.g., plasma, serum, urine).
• Pharmaceutical Research: Supports method development and validation in pharmacokinetic (PK) and bioequivalence studies for steroid-based therapies.
• Metabolic Studies: Aids in tracing and quantifying metabolic pathways and degradation products of the parent compound.
• Quality Control & Assurance: Employed in analytical laboratories to ensure the precision and accuracy of assay methods for active pharmaceutical ingredients (APIs).
• Reference Material: Serves as a certified reference material (CRM) for calibrating analytical instrumentation.

Basic Information

Product Name	δ-4-Tibolone D5
CAS No.	1162-60-3
Molecular Formula	C21H23D5O2
Molecular Weight	317.49 g/mol
Synonyms	7α,17α-17-Hydroxy-7-methyl-19-norpregn-5(10)-en-20-yn-3-one D5; Tibolone D5; Livial D5; Org OD-14 D5; (7α,17α)-17-Hydroxy-7-methyl-19-norpregn-5(10)-en-20-yn-3-one-d5; Deuterated Tibolone; Tibolone Internal Standard
EINECS	Contact for details

Quality Control

Our δ-4-Tibolone D5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for chemical purity and isotopic enrichment, NMR for structural confirmation, and mass spectrometry for identity verification. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specifications for use as an analytical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D5)	≥ 98.0 atom % D
Chemical Purity (HPLC)	≥ 99.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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