Acetylcysteine, N-Acetylcysteine, Acetyl-L-Cysteine, Acetylcysteinum, NAC, 616-91-1

Acetylcysteine, N-Acetylcysteine, Acetyl-L-Cysteine, Acetylcysteinum, NAC, 616-91-1

ACETYLCYSTEINE (N-ACETYLCYSTEINE / NAC)

Acetylcysteine / N-Acetyl-L-cysteine / NAC

CAS Number: 616-91-1

EC Number: 210-498-3

1. IDENTIFICATION

2. PHYSICAL PROPERTIES

3. CHEMICAL PROPERTIES

Chemical Structure:

HOOC-CH(NHCOCH₃)-CH₂-SH

Dimerization (Oxidation):

2 NAC (HS-) + [O] → NAC-S-S-NAC (N-Acetylcysteine disulfide / DiNAC)

4. MECHANISM OF ACTION

4.1. Mucolytic Effect

4.2. Antioxidant Effect (Glutathione Precursor)

4.3. Paracetamol (Acetaminophen) Antidote

5. PHARMACEUTICAL FORMS

6. APPLICATIONS (THERAPEUTIC USES)

6.1. Respiratory Diseases (Mucolytic) – Primary Use

Typical Adult Dosage: 600 mg once daily (or 200 mg 2-3 times daily) as effervescent tablet or sachet

6.2. Paracetamol (Acetaminophen) Overdose – Antidote

6.3. Antioxidant & Liver Protection

6.4. Psychiatric & Neurological Applications (Research/Adjunctive)

6.5. Other Applications

7. DOSAGE GUIDELINES (THERAPEUTIC)

8. QUALITY SPECIFICATIONS (PHARMACEUTICAL GRADE)

9. SAFETY & HEALTH INFORMATION

GHS Classification (for bulk powder)

Hazard Statements (H-Codes)

Precautionary Statements (P-Codes)

Adverse Effects (Therapeutic Use)

Contraindications

First Aid Measures

10. DRUG INTERACTIONS

11. STORAGE & HANDLING

Storage Note: NAC is sensitive to oxidation. Store in airtight containers, preferably under nitrogen blanket for long-term storage. Elevated temperature and humidity accelerate degradation.

12. ENVIRONMENTAL INFORMATION

13. TRANSPORT INFORMATION

14. REGULATORY INFORMATION

15. SYNONYMS & OTHER NAMES

Trade Names (Turkey & Global):

16. NATURAL SOURCES

Note: Natural sources contain only trace amounts. Pharmaceutical and supplement NAC is produced synthetically.

17. COMPARISON: NAC vs L-CYSTEINE vs GLUTATHIONE

18. SUMMARY

Acetylcysteine (N-Acetylcysteine / NAC, CAS 616-91-1) is an acetylated derivative of the amino acid L-cysteine. It is a versatile pharmaceutical agent with three primary mechanisms: mucolytic (breaks disulfide bonds in mucus), antioxidant (precursor to glutathione), and hepatoprotective (antidote for acetaminophen/paracetamol overdose).

Key Features:

Main Therapeutic Applications:

Pharmaceutical Forms:

• Effervescent tablets (200 mg, 600 mg)

• Sachets/granules (200 mg, 600 mg, 900 mg, 1200 mg)

• Syrup/oral solution (100-200 mg/5 mL)

• Capsules/tablets (600 mg)

• IV injection/infusion (150-200 mg/mL)

• Inhalation solution (100-200 mg/mL)

Key Safety Points:

• WELL-TOLERATED – Generally safe at therapeutic doses

• SIDE EFFECTS – Nausea, vomiting, diarrhea (common); allergic reactions (rare)

• STORAGE – Protect from moisture and air; store in airtight containers

• RX STATUS – Prescription drug for therapeutic use (mucolytic, antidote); available as dietary supplement in some countries (e.g., USA)

19. IMPORTANT NOTES

1. Pharmaceutical vs Supplement Grade: Pharmaceutical grade NAC (for prescription drugs) meets stricter purity standards (pharmacopeia compliance: USP, Ph. Eur., JP). Supplement grade NAC may have less stringent quality requirements. Always specify required grade for your application.

2. Oxidation Sensitivity: NAC contains a free thiol group (-SH) that readily oxidizes in air to form N-acetylcysteine disulfide (DiNAC). This dimer is less active. Store in airtight containers; for long-term storage, consider nitrogen blanketing.

3. Mucolytic Mechanism: NAC directly breaks disulfide bonds in mucus glycoproteins, thinning viscous secretions. This is a chemical (not enzymatic) process.

4. Paracetamol Overdose Timing: NAC is most effective within 8-10 hours of paracetamol ingestion. After this window, efficacy decreases but treatment is still beneficial. Always hospital setting for IV administration.

5. Effervescent Tablet Preparation: Effervescent tablets must be dissolved in water (not swallowed whole). If vomiting occurs within 1 hour of administration, redosing may be required.

6. Nebulizer Use: Inhalation solution should be used with a nebulizer. The solution may have a sulfur-like odor (characteristic, not an indication of degradation). Clean equipment after each use.

7. Allergic Reactions: Although rare, severe allergic reactions (anaphylaxis, angioedema, bronchospasm) can occur. Patients with asthma are at higher risk for bronchospasm with inhaled NAC.

8. Drug Interactions: NAC may enhance the vasodilatory effect of nitroglycerin (hypotension risk). Administer antibiotics separately (2 hours apart) as NAC may reduce their efficacy when mixed.

9. Cosmetic Use: NAC is used in some cosmetic formulations (anti-aging, skin lightening) for its antioxidant properties. However, regulatory status varies by country.

10. Regulatory Status Variation: NAC is regulated differently across countries. In the US, it is available both as a prescription drug (Acetadote®, Mucomyst®) and as a dietary supplement. In the EU and Turkey, NAC is primarily a prescription-only medication (some OTC status for low-dose mucolytic). Always check local regulations.

Important Disclaimer: This Technical Data Sheet (TDS) is for informational purposes only. For complete safety, handling, storage, and regulatory compliance information, always refer to the official Safety Data Sheet (SDS) and product information provided by the manufacturer/supplier. This document is not a substitute for medical advice. NAC should only be used under medical supervision for therapeutic indications.