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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Category: Active Pharmaceutical Ingredients (APIs) Tags: Anticholinergic agent, Cyclopentolate hydrochloride, Pharmaceutical Raw Material, White to off-white powder

Description

Table of Contents

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.

KEY PRODUCT 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.