Hydrocortisone Acetate Amaris Chemicals
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PHARMACEUTICAL GRADE

Hydrocortisone Acetate

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Hydrocortisone Acetate is a synthetic corticosteroid ester derived from hydrocortisone (cortisol). It is a white to off-white crystalline powder, practically insoluble in water but soluble in alcohol and acetone. This compound exhibits potent anti-inflammatory, immunosuppressive, and anti-allergic properties, making it widely used in pharmaceutical and dermatological formulations. Hydrocortisone Acetate acts by modulating gene expression to reduce the production of inflammatory mediators, thereby alleviating symptoms in various inflammatory and autoimmune conditions.

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Description

Hydrocortisone Acetate

Primary Uses 

  1. Pharmaceutical and Medical
  • Used extensively as an active pharmaceutical ingredient (API) in topical formulations (creams, ointments, lotions) for treating skin disorders such as eczema, psoriasis, dermatitis, and allergic reactions.
  • Applied in injectable formulations for systemic anti-inflammatory and immunosuppressive therapy.
  • Incorporated into ophthalmic preparations for managing eye inflammations.
  • Utilized in intramuscular or intralesional injections to treat localized inflammation and autoimmune diseases.
  • Plays a role in replacement therapy for adrenal insufficiency and certain endocrine disorders.
  1. Veterinary Medicine
  • Used similarly in veterinary formulations to treat inflammatory and allergic conditions in animals.

Secondary Uses 

  1. Cosmetic Industry
  • Occasionally incorporated into dermatological cosmetic formulations for anti-inflammatory benefits in sensitive or problem skin products (with strict regulatory limits).
  1. Biomedical Research
  • Utilized in experimental models to study inflammation, immune responses, and corticosteroid pharmacodynamics.
  • Used to investigate corticosteroid receptor interactions and gene expression pathways.
  1. Combination Formulations
  • Combined with antibiotics, antifungals, or antiseptics in multi-action topical products for enhanced therapeutic effects.
KEY PRODUCT FEATURES

1. Basic Identification Attributes

  • Chemical Name (IUPAC): (11β)-11,17,21-Trihydroxypregn-4-ene-3,20-dione 21-acetate
  • Common/Trade Name: Hydrocortisone Acetate
  • CAS Number: 50-03-3
  • HS Code: 2937.29.00
  • Molecular Formula: C23H32O6
  • Synonyms: Cortisol acetate; Hydrocortisone 21-acetate; 11β,17α,21-Trihydroxypregn-4-ene-3,20-dione 21-acetate

2. Physical & Chemical Properties

  • Physical State: Crystalline powder
  • Color & Odor: White to off-white; odorless or faint odor
  • Melting Point: 220–225 °C (decomposes)
  • Solubility: Practically insoluble in water; soluble in ethanol, acetone, and chloroform
  • Stability: Stable under recommended storage, sensitive to light and moisture

3. Safety & Hazard Attributes

  • GHS Classification: Not classified as hazardous under normal handling; potential irritant
  • Toxicity: Low acute toxicity; long-term use may cause systemic corticosteroid effects
  • Exposure Limits: No specific occupational limits, but good industrial hygiene is recommended

4. Storage & Handling Attributes

  • Container Type: Airtight, moisture-proof containers (glass or high-density polyethylene)
  • Storage Conditions: Store in a cool, dry, dark place, away from heat and direct sunlight
  • Shelf Life: Typically 24 months under recommended storage conditions
  • Handling Notes: Avoid inhalation of dust; use in well-ventilated areas

5. Regulatory & Compliance Attributes

  • Approved for pharmaceutical use globally (FDA, EMA, WHO monographs)
  • Controlled substance regulations vary by country due to corticosteroid properties
  • Usage strictly regulated in cosmetics due to potency and side effect profile

6. Environmental & Health Impact

  • Biodegradability: Expected to degrade in environment, but slow due to steroid structure
  • Ecotoxicity: Potential endocrine disruptor; should be managed to avoid environmental contamination
  • Bioaccumulation: Not expected significantly
  • Carcinogenicity/Mutagenicity: Not classified as carcinogenic
SAFETY HANDLING PRECAUTIONS

Safety Handling Precautions

  • PPE Required: Gloves, dust mask, protective eyewear if handling powder
  • Handling Guidelines: Use in well-ventilated areas, avoid generating dust, prevent skin and eye contact
  • Hygiene Practices: Wash hands after handling; avoid eating or smoking during use

First Aid Measures

  • Inhalation: Move to fresh air; seek medical advice if symptoms develop
  • Skin Contact: Wash thoroughly with soap and water; seek medical attention if irritation occurs
  • Eye Contact: Rinse eyes with plenty of water for at least 15 minutes; consult a doctor if irritation persists
  • Ingestion: Rinse mouth; seek medical attention for significant ingestion

Firefighting Measures

  • Fire Hazards: Combustible powder; emits toxic fumes including CO, CO₂, and other combustion products
  • Extinguishing Media: Water spray, foam, dry chemical, or CO₂
  • Special Precautions: Firefighters should wear protective equipment and self-contained breathing apparatus
  • Decomposition Products: Carbon oxides, steroid fragments

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