Wusu, Tacheng Prefecture, Xinjiang, China admin@sinochem-nanjing.com 3389378665@qq.com
Follow us:



MSDS: Naproxen - USP Grade (For Export)

Identification

Substance Name: Naproxen
Grade: USP Grade
CAS Number: 22204-53-1
Synonyms: (S)-6-Methoxy-α-methyl-2-naphthaleneacetic acid
Recommended Use: Pharmaceutical applications, pain relief medication
Manufacturer: Details of exporting manufacturer, contact information, emergency phone numbers, and oversight authority
Physical Form: White to off-white crystalline powder, odorless
Packaging: Sealed, tamper-evident HDPE containers with full labeling

Hazard Identification

Classification: Not classified as a hazardous chemical under GHS for handling, but irritation or harmful effects arise with direct contact, dust inhalation, or ingestion in high doses
Routes of Entry: Skin, eye, inhalation, ingestion
Potential Effects: Irritation to eyes and respiratory tract, allergy risk after prolonged exposure, high dose ingestion risks gastrointestinal upset, and headache
Pictograms: No standard GHS pictogram assigned, general caution for pharmaceutical product
Signal Word: Caution

Composition / Information on Ingredients

Main Ingredient: Naproxen (purity > 98%)
Chemical Formula: C14H14O3
Percentage: 98-100% Naproxen by weight
Excipients: None with pure grade
Possible Contaminants: Trace process-related impurities, within pharmacopeial limits
Impurities Reporting: Full quantitative breakdown provided in product specification documents

First Aid Measures

Eye Contact: Rinse with clean water for several minutes, remove contacts if present, and seek medical advice if irritation persists
Skin Contact: Wash area with mild soap and water; contaminated clothing should be cleaned before reuse
Inhalation: Move outdoors or to well-ventilated area, get medical assistance if symptoms occur
Ingestion: Rinse mouth, do not induce vomiting, get professional support if large amounts ingested
Most Important Symptoms: Nausea, headache, ocular discomfort, skin redness

Fire-Fighting Measures

Suitable Extinguishing Media: Water spray, dry chemical, foam, CO2 extinguishers
Specific Hazards: Powder may form dust clouds that pose explosion risks, produces carbon oxides and toxic fumes when burned
Protective Equipment: Full protective gear and self-contained breathing apparatus; evacuate unnecessary personnel
Special Procedures: Prevent run-off into waterways, use water spray to cool exposed containers

Accidental Release Measures

Personal Precautions: Avoid dust formation, ventilate area thoroughly, wear dust mask and gloves
Environmental Precautions: Keep spilled powder away from drains, watercourses, and soil
Cleanup Methods: Sweep or scoop material, avoid raising dust, place in suitable container for disposal, wash area with water after collection
Spill Response: Notify safety personnel and handle according to established protocols

Handling and Storage

Safe Handling: Use local exhaust ventilation, minimize dust generation, avoid breathing powders, wash hands after handling
Storage Requirements: Store sealed in original packaging, cool dry environment, away from sunlight and incompatible substances like strong oxidizers
Incompatibilities: Bases, oxidizing agents, acids
Special Precautions: Keep out of reach of unauthorized persons, maintain inventory records and access logs

Exposure Controls and Personal Protection

Exposure Guidelines: No specific occupational exposure limits noted, handle as low-toxicity pharmaceutical compound
Engineering Controls: Fume hood or exhaust ventilation, closed operations recommended in production environments
Personal Protective Equipment: Chemical splash goggles, disposable gloves, dust mask or NIOSH-approved respirator, lab coat or dust-resistant clothing
Hygienic Measures: Always wash hands and face after use, no smoking, eating, or drinking in work area

Physical and Chemical Properties

Appearance: White to slightly off-white crystalline powder
Odor: Odorless
pH: 6-8 (saturated solution in water)
Melting Point: 153-157°C
Boiling Point: Data not available (decomposes)
Solubility: Slightly soluble in water, more soluble in ethanol, ether, and chloroform
Vapor Pressure: Negligible at ambient conditions
Partition Coefficient: Log Pow: 3.18
Other: Stable under recommended conditions, does not support combustion

Stability and Reactivity

Chemical Stability: Stable under normal pharmaceutical storage and handling
Conditions to Avoid: Excessive heat, moisture, direct sunlight
Hazardous Reactions: Reacts with strong oxidizers to generate harmful byproducts
Decomposition Products: Carbon monoxide, carbon dioxide, potentially irritating fumes
Polymerization: Does not occur

Toxicological Information

Acute Toxicity: LD50 (oral, rat): ~ 248 mg/kg
Chronic Exposure: May cause kidney or liver effects at high doses during long-term exposure
Irritation: Mildly irritating to eyes and skin with direct contact
Allergenic Sensitivity: Sensitization rare but possible
Carcinogenicity: Not listed as carcinogen by IARC, NTP, OSHA
Target Organs: Kidney, liver, gastrointestinal tract
Symptoms of Overexposure: Abdominal pain, nausea, drowsiness, headache, allergic skin reactions in sensitive individuals

Ecological Information

Aquatic Toxicity: Harmful to aquatic organisms with long-term exposure
Persistence and Degradability: Slightly biodegradable in soil and water
Bioaccumulation: Low potential due to moderate partition coefficient
Mobility in Soil: Low, limited water solubility
Special Orders: Do not release into environment, follow regulatory pollution prevention practices

Disposal Considerations

Waste Management: Dispose as non-hazardous pharmaceutical waste in accordance with local, regional, and national regulations
Methods: Incineration or landfill with approved contractor
Packaging Disposal: Clean, puncture, and recycle if possible, otherwise manage as pharmaceutical-contaminated waste
Avoid: Land application, direct discharge to water sources, or municipal sewage

Transport Information

UN Number: Not classified as dangerous goods for transport
Transport Name: Naproxen, USP Grade
Hazard Class: None
Packing Group: None
Labels: Not regulated
Special Precautions for User: Keep sealed during transit, maintain documentation, ship according to pharmaceutical cargo standards
International Transport: Complies with IATA, IMDG, and DOT regulations

Regulatory Information

Regulatory Status: Complies with US FDA, European Pharmacopoeia, and applicable Indian export standards
Inventory Listings: Listed in TSCA, EINECS, DSL, AICS
Labeling Requirements: Follows standards for pharmaceutical substances; specific hazard, batch number, and handling guidance included
Restriction of Use: Prescription-only medication, not for over-the-counter sale
Occupational Controls: Subject to periodic workplace audits and health surveillance