Description

Progesterone Bisnoraldehyde Impurity is a key chemical reference standard used in the analytical profiling and quality control of progesterone and related steroid hormone APIs. This compound is critical for pharmaceutical manufacturers and research laboratories to identify, quantify, and control process-related impurities, ensuring final product safety and regulatory compliance. It is essential for quality assurance programs within the pharmaceutical, biotechnology, and advanced research sectors.

Application

• Pharmaceutical Impurity Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in progesterone Active Pharmaceutical Ingredient (API) batches.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC method development to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed as a system suitability standard in routine QC testing to monitor manufacturing process consistency and impurity levels.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Research & Development: Utilized in synthetic chemistry R&D to study degradation pathways and optimize purification processes for progesterone and its analogs.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of progesterone formulations.

Basic Information

Product Name	Progesterone Bisnoraldehyde Impurity
CAS No.	81201-82-3
Molecular Formula	C20H28O2
Molecular Weight	300.44 g/mol
Synonyms	Pregna-4,9(11)-diene-3,20-dione, 17-(2-Oxoethyl)-; 17-(2-Oxoethyl)androsta-4,9(11)-diene-3-one; Progesterone Bisnor Aldehyde; Progesterone Degradant; Progesterone Related Compound; 17β-(2-Oxoethyl)-androsta-4,9(11)-dien-3-one; 17-(Acetyl)gon-4,9(11)-dien-3-one (obsolete); Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Progesterone Bisnoraldehyde Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and chromatographic data is provided with each shipment.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccant use within the primary container.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Assay	≥ 97.0% (on dried basis)
Loss on Drying	≤ 2.0%
Residue on Ignition	≤ 0.5%
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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