Description

Testosterone Propionate Impurity 5 is a high-purity reference standard critical for analytical and regulatory purposes in the pharmaceutical industry. This compound serves as a key impurity marker for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Testosterone Propionate. It is an essential material for pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in method development, validation, and compliance testing. The precise characterization of this impurity is fundamental to meeting stringent pharmacopeial standards and regulatory requirements for steroid-based therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Testosterone Propionate Impurity 5 in API and finished drug product testing.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Testosterone Propionate batches.
• Quality Control & Assurance: Employed in routine QC testing to ensure API purity complies with pharmacopeial monographs (e.g., USP, EP, BP) and ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products in Testosterone Propionate under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filings: Critical for preparing regulatory submission documents (e.g., DMF, CMC sections) to demonstrate comprehensive impurity profiling.
• Research & Development: Supports synthetic chemistry research for process optimization and impurity synthesis pathway studies.

Basic Information

Product Name	Testosterone Propionate Impurity 5
CAS No.	25862-97-9
Molecular Formula	C22H32O3
Molecular Weight	344.49 g/mol
Synonyms	Androst-4-en-3-one, 17-(1-oxopropoxy)-, (17β)-; 17β-Hydroxyandrost-4-en-3-one 17-propionate; Testosterone 17-propionate impurity; Testosterone propionate related compound; δ-4-Androsten-17β-propionoxy-3-one; Steroid impurity; Androgen impurity; Pharmacopeial impurity standard
EINECS	Contact for details

Quality Control

Every batch of Testosterone Propionate Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic purity, and traceability data.

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 material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%

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