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Cyclopentolate HCL

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Cyclopentolate Hydrochloride (HCL) is a synthetic anticholinergic agent used primarily in ophthalmology. It appears as a white to off-white crystalline powder, soluble in water, with a slightly bitter taste. Cyclopentolate HCL works by temporarily paralyzing the muscles of the eye’s ciliary body and iris, causing pupil dilation (mydriasis) and paralysis of accommodation (cycloplegia). It is commonly formulated into eye drops for diagnostic procedures and therapeutic applications involving the eye.

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Description

Cyclopentolate HCL Uses

Primary Uses 

Ophthalmic Diagnostics and Therapeutics

  • Used as a mydriatic and cycloplegic agent to dilate pupils during eye examinations.

  • Facilitates accurate measurement of refractive errors by temporarily paralyzing accommodation.

  • Employed to treat uveitis and other inflammatory conditions of the eye by reducing muscle spasms and pain.

  • Used in preparation for ocular surgeries and diagnostic procedures such as fundoscopy.

Pharmaceutical Formulations

  • Incorporated in eye drop formulations for controlled, topical delivery to the eye.

  • Used in combination with other ophthalmic agents for therapeutic regimens addressing eye inflammation and injury.

 

Secondary Uses 

Research Applications

  • Utilized in pharmacological research to study autonomic nervous system responses and ocular pharmacodynamics.

  • Applied in experimental models investigating mechanisms of cycloplegia and mydriasis.

Compounding Pharmacy

Used by compounding pharmacies to prepare custom ophthalmic solutions with specific concentrations tailored to patient needs.

PRODUCT KEY FEATURES

1. Basic Identification Attributes

  • Chemical Name (IUPAC): (RS)-2-(Dimethylamino)ethyl 1-cyclopentyl-1-phenyl-1,3-dioxan-5-ylcarboxylate hydrochloride

  • Common/Trade Name: Cyclopentolate Hydrochloride (Cyclopentolate HCL)

  • CAS Number: 522-20-7

  • HS Code: 2941.90.90

  • Molecular Formula: C17H25NO3·HCl

  • Synonyms:

    • Cyclopentolate HCl

    • Cyclopentolate Hydrochloride

 

2. Physical & Chemical Properties

  • Physical State: White to off-white crystalline powder

  • Color & Odor: White/off-white; odorless

  • Melting Point: 135–138°C (decomposes)

  • Boiling Point: Not applicable (decomposes before boiling)

  • Density: Not applicable (solid powder)

  • Solubility:

    • Freely soluble in water

    • Slightly soluble in alcohol and acetone

  • Stability: Stable under normal conditions; hygroscopic

 

3. Safety & Hazard Attributes

  • Hazard Class (GHS): Not classified as hazardous under normal use; may cause irritation

  • NFPA Ratings:

    • Health: 1

    • Flammability: 0

    • Reactivity: 0

  • Exposure Limits: No established occupational exposure limits; handle with care

  • Toxicity: Toxic if ingested in large amounts; may cause anticholinergic side effects (dry mouth, tachycardia, blurred vision) if systemically absorbed

  • Reactivity: Stable; avoid strong oxidizing agents

 

4. Storage & Handling Attributes

  • Storage Conditions: Store in a cool, dry place protected from light and moisture

  • Container Type: Airtight, light-resistant containers

  • Shelf Life: Typically 2–3 years if stored properly

  • Special Handling: Avoid inhalation of dust; use PPE (gloves, masks) during handling

 

5. Regulatory & Compliance Attributes

  • FDA Status: Approved for ophthalmic use as per pharmaceutical regulations

  • REACH Status: Registered chemical substance for pharmaceutical use

  • Transportation: Not classified as hazardous for transport

  • Waste Disposal: Dispose according to pharmaceutical waste guidelines; avoid environmental contamination

 

6. Environmental & Health Impact

  • Ecotoxicity: Low environmental impact; avoid release into waterways

  • Persistence: Not persistent in the environment; degrades under normal conditions

  • Bioaccumulation: Not expected to bioaccumulate

  • Carcinogenicity/Mutagenicity: No evidence of carcinogenicity or mutagenicity

Biodegradability: Expected to be biodegradable

SAFETY HANDLING PRECAUTIONS

  • Safety Handling Precautions

Personal Protective Equipment (PPE):

  • Protective gloves

  • Dust mask or respirator (to avoid inhalation of powder)

  • Safety goggles

Handling Measures:

  • Avoid dust formation and inhalation

  • Use in well-ventilated areas

  • Avoid contact with skin and eyes

Storage Measures:

  • Keep containers tightly closed

  • Store in a cool, dry place away from light and moisture

Hygiene Practices:

  • Wash hands thoroughly after handling

  • Avoid eating, drinking, or smoking during handling

 

First Aid Measures

  • Inhalation: Move person to fresh air; if breathing difficulty occurs, seek medical attention.

  • Skin Contact: Wash affected area with soap and water; seek medical advice if irritation develops.

  • Eye Contact: Rinse eyes immediately with plenty of water for at least 15 minutes; seek medical attention if irritation persists.

  • Ingestion: Do not induce vomiting; seek immediate medical assistance.

 

Firefighting Measures

  • Fire Hazards: Not highly flammable but may decompose on heating producing toxic fumes.

  • Extinguishing Media: Use water spray, foam, dry chemical, or carbon dioxide.

  • Special Precautions: Firefighters should wear protective equipment and self-contained breathing apparatus.

  • Decomposition Products: May emit toxic gases such as nitrogen oxides and hydrochloric acid.

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