Description

Anecortave Acetate Related Compound A (20 Mg) (9(11)-Dehydrocortisol) is a high-purity analytical reference standard and a key synthetic intermediate in the production of angiostatic corticosteroids. This compound is critical for pharmaceutical research and development, particularly in the study of ocular diseases and anti-angiogenic therapies. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for method development, quality control, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Anecortave Acetate and related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Process Development & Validation: Serves as a critical intermediate and impurity marker in the synthesis and scale-up of Anecortave Acetate, aiding in process optimization and validation studies.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods to ensure accurate assay and impurity profiling in compliance with ICH guidelines.
• Quality Control & Assurance: Employed in in-house QC laboratories to calibrate instruments and verify the purity of production batches against established specifications.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research on Angiogenesis Inhibitors: Used in preclinical and biochemical research to study the structure-activity relationships of corticosteroid derivatives that inhibit abnormal blood vessel growth.

Basic Information

Item	Detail
Product Name	Anecortave Acetate Related Compound A (20 Mg) (9(11)-Dehydrocortisol)
CAS No.	10184-70-0
Molecular Formula	C21H28O5
Molecular Weight	360.45 g/mol
Synonyms	9(11)-Dehydrocortisol; 9,11-Dehydrocortisol; 17,21-Dihydroxypregna-4,9(11)-diene-3,20-dione; 9(11)-Dehydro-17α,21-dihydroxypregn-4-ene-3,20-dione; Anecortave Acetate Impurity; Anecortave Acetate Related Substance A; 11-Dehydrocortisol (ambiguous); Pregna-4,9(11)-diene-3,20-dione, 17,21-dihydroxy-
EINECS	Contact for details

Quality Control

Every batch of Anecortave Acetate Related Compound A is manufactured under strict quality management systems and undergoes comprehensive analytical testing. Our quality control protocols are designed to meet the stringent requirements of pharmaceutical reference standards, ensuring identity, purity, and strength. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results from tests including HPLC assay, related substances, residual solvents, and identity confirmation (IR, MS). We support compliance with ICH Q3A, Q3B, and Q6A guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

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%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Loss on Drying	≤ 1.0%
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.