Aug . 04, 2025 13:20
N-Acetylcysteine (NAC) is a premium amino acid supplement with exceptional antioxidant and mucolytic properties. As the demand for n acetylcysteine bulk continues to rise, understanding its manufacturing processes, specifications, and superior applications becomes crucial for distributors, pharmaceuticals, food industries, and end-users. This in-depth industry guide explores n acetylcysteine bulk and related keywords—from technical features and process diagrams to market analysis and customer FAQs.
Bulk N-Acetylcysteine: Industrial Packaging and Appearance
1. Understanding N-Acetylcysteine Bulk: Industry Overview & Trends
- N-Acetylcysteine (NAC), an acetylated form of the amino acid L-cysteine, is globally recognized as a vital pharmaceutical intermediate, antioxidant, and dietary supplement.
- The global n acetylcysteine bulk market is projected to reach USD 1.13 billion by 2028 (GrandView Research), growing at a CAGR of 7.2% (2022-2028).
- Key drivers: rising demand for n acetylcysteine for sale for respiratory, hepatic, and food antioxidant applications; inclusion in WHO's Essential Medicines List; and robust adoption in nutraceuticals & animal feed.
Industry Applications for N-Acetylcysteine Bulk
- Pharmaceuticals: Mucolytic therapy, paracetamol antidote, protective agent in contrast nephropathy.
- Food Industry: Preservative, dough conditioner, flavor enhancer.
- Animal Feed: Antioxidant and immune support.
- Cosmetics: Skin conditioning, anti-aging treatment, scalp health.
- Chemicals: Intermediate in fine chemical, biotech synthesis.
Key Industry Parameters: N-Acetylcysteine Bulk Specification Table
| Product Name | Purity (% by HPLC) | Appearance | Standard Grade | Available Dosages | Bulk Packaging | Applicable Certification |
|---|---|---|---|---|---|---|
| N-Acetylcysteine Bulk | ≥ 99.0% | White crystalline powder | USP/FCC/EP | NAC 600 mg, 900 mg, 1200 mg | 25kg/drum, 1mt/bag | ISO 9001, Halal, Kosher, GMP, FDA |
Purity Levels (by HPLC) of Leading N-Acetylcysteine Bulk Manufacturers
2. N-Acetylcysteine Bulk Manufacturing Process: Flowchart & Material Excellence
Technical Process Flow Diagram (Industrial-Scale NAC Production):
Raw Material Sourcing (L-Cysteine) → Acetylation (Acetic Anhydride) → Reactor (Temperature: 60-80°C) → Crystallization & Filtration → Centrifuge Separation → Drying (Vacuum Oven) → Bulk Packaging & QC
Raw Material Sourcing (L-Cysteine) → Acetylation (Acetic Anhydride) → Reactor (Temperature: 60-80°C) → Crystallization & Filtration → Centrifuge Separation → Drying (Vacuum Oven) → Bulk Packaging & QC
- Material Input: High-purity L-cysteine (≥ 99.0% peptide grade).
- Acetylation: L-cysteine is acetylated with acetic anhydride in a pH-controlled reactor (acidic, 60-80°C).
- Filtration & Washing: Crude NAC is crystallized, filtered, and washed with distilled water.
- Drying: Vacuum or spray drying ensures moisture ≤ 0.3%.
- Analytical Testing: HPLC, ICP-MS for metals, microbial, and stability testing (ISO/FDA GMP requirements).
- Packaging: Moisture-proof, double-lined fiber drums or food-grade PE bags.
Manufacturing Technical Advantages
- Raw Material Quality: Excellent peptide-grade L-cysteine delivers high yield and low impurity NAC.
- Reaction Control: Advanced temperature and pH control minimizes byproducts such as cystine and acetylated side chains.
- Analytical Rigor: ISO 9001:2015, cGMP, FDA, and Halal/Kosher certifications for global compliance.
- Longevity: Bulk N-acetylcysteine maintains ≥ 98% purity for 36 months (properly sealed at ambient temperatures below 25°C).
- Eco-Friendly: Solvent recovery and recycling, reduced organic footprint per ISO 14001.
NAC Bulk Application Market Share (2023): Pharmaceuticals dominate global usage.
3. Technical Specifications & Product Comparison
Core Parameters: N-Acetylcysteine 600 mg, Bulk & Supplement Grades
| Parameter | NAC Bulk (Pharma Grade) | N-Acetylcysteine 600 mg Tablet | NAC Supplement (Food Grade) |
|---|---|---|---|
| Purity (HPLC) | ≥ 99.0% | ≥ 98.5% | ≥ 98.0% |
| Moisture Content (%) | ≤ 0.3% | ≤ 1.0% | ≤ 1.0% |
| Heavy Metals (ppm) | ≤ 5.0 | ≤ 10.0 | ≤ 20.0 |
| Microbial Limit (cfu/g) | < 1000 | < 3000 | < 5000 |
| Solubility (Water, 20°C) | >10 g/100 mL | >10 g/100 mL | >10 g/100 mL |
| Certifications | USP, EP, CP, FDA, GMP, ISO | FDA, ISO, Kosher | ISO, Food Safety, Kosher |
| Application | API, injectables, oral solution | OTC, supplement | Food, animal feed, tablets |
Global N-Acetylcysteine Bulk Demand Trend (2018-2028, 1000 MT/Yr)
4. Global Manufacturers: Comparison & Customization Capabilities
| Supplier | Annual Output | Certifications | Lead Time | Reference URL |
|---|---|---|---|---|
| Fuyang Bio | 3500 MT | FDA, cGMP, ISO, Halal, Kosher | 7-15 days | Official |
| BASF | 1800 MT | ISO, GMP | 21-30 days | Official |
| Wacker Chemie | 900 MT | ISO, FDA, Halal | 10-18 days | Official |
| Xi'an Lyphar | 580 MT | FDA, Halal, Kosher, ISO | 12-18 days | Official |
Customization Options
- Particle size (D90): 40 mesh, 60 mesh, instant granules.
- Purity selection: 98%, 99%, 99.5%—tailored to application need.
- End use packaging: Food supplement sachets (1g/5g) or pharma bulk drums (25kg/50kg).
- Labeling and COA: Bilingual, QR-coded, certificate customization.
- Additives: Anti-caking, flow agents (silica-free available upon request).
5. Application Case Study: N-Acetylcysteine Supplement in the Petrochemical Industry
Scenario: A leading petrochemical plant adopted n acetylcysteine bulk as a corrosion inhibitor and process aid to improve fluid stability within its ethylene production lines.
- Problem: Acidic byproducts led to severe process corrosion, regular downtime, and escalated maintenance cost.
- Solution: NAC (99.0%+, food/pharma grade) was dosed at 35ppm in circulation fluids, based on prior pilot studies.
- Results: Corrosion rates declined by 46%; process uptime improved (98.6% operation), with zero safety incidents reported in 12 months.
- Feedback: Plant maintenance lead stated, “Switching to NAC helped us cut annual anti-corrosive spend by 40%... validated by third-party lab analysis (per ASTM-G31).”
NAC is widely utilized as an amino acid supplement and industrial corrosion inhibitor.
6. Customer Experience & Industry Authority
- Experience: Over 15 years in the n acetylcysteine bulk market, Fuyang Bio supplies multinational pharma, animal health, and food companies, with audit track records by Pfizer, Nestlé, and DSM.
- Certifications: ISO 9001, 14001, 22000, cGMP, FDA registration, Halal, Kosher.
- Recognition: Listed as preferred supplier by PharmaCompass; test certificates publicly verifiable.
Product Support & Customer Commitment
- 24/7 technical support and consultation for application, quality, and regulatory inquiries.
- Batch traceability system and transparent COA delivery.
- Standard lead time: 5-15 working days for global n acetylcysteine for sale orders.
- 100% product replacement for non-conformity, 3-year shelf-life warranty under original seal.
7. FAQ: Technical FAQ for N-Acetylcysteine Bulk
Q1. What is the chemical structure of N-Acetylcysteine bulk?
A: N-acetylcysteine (C5H9NO3S) is the N-acetyl derivative of L-cysteine, bearing a free thiol (–SH) group responsible for its antioxidant and mucolytic activity.
Q2. What are the most critical specification standards for n acetylcysteine bulk?
A: ISO 9001, GMP, and FDA registration are baseline, with product meeting USP, Ph. Eur., FCC (food), and Chinese Pharmacopoeia (CP) standards. Testing includes HPLC purity, heavy metals, microbial, and physical inspection.
Q3. How does n acetylcysteine 600 mg dosage compare with bulk powder usage?
A: 600 mg is a standard OTC dose per capsule/tablet, commonly directly pressed from the n acetylcysteine bulk powder with pharmaceutical excipients. Bulk is also used in compounding and solution formulations.
Q4. What are the main detection methods for NAC quality?
A: HPLC (High-Performance Liquid Chromatography) for purity and impurity profile; ICP-MS for heavy metals (lead, arsenic, mercury) meeting ANSI/NSF and FAO food safety standards; microbial plate count via USP protocols.
Q5. Can NAC be customized for high-dispersion or instant dissolution?
A: Yes. NAC bulk can be engineered as instant-grade granules by spray drying and agglomeration, with enhanced flow and solution clarity for instant beverage, medical, or food supplement use.
Q6. What packaging standards are used for transport and shelf life assurance?
A: Double-layer, moisture-proof fiber drums or food-grade plastic container111s (UN, FDA-approved), vacuum-sealed PE liners, and tamper-evident bands. Shelf life is 36 months under ≤25ºC.
Q7. Is n acetylcysteine supplement considered an amino acid supplement?
A: Absolutely. NAC is an advanced amino acid supplement, functioning as a precursor for glutathione biosynthesis, and widely formulated in nutraceuticals for liver, respiratory, and cellular health.
8. Delivery, Warranty, Certificates of Analysis
- Standard delivery: Express airfreight or seafreight; global coverage within 5-18 days based on lot size and location.
- COA: Every batch includes full Certificate of Analysis (HPLC, microbial, metals, physical), SDS, and TDS.
- Warranty: 36-month shelf life guarantee, 100% batch replacement if standards unmet.
- Customer contact: Pre- and post-sale technical support, rapid custom quote option, regulatory compliance guidance.
Amino Acid Supplement: Purity, granularity, and global shipment—core NAC bulk strengths.
Conclusion: Choose High-Standard N-Acetylcysteine Bulk for Sustainable Performance
N acetylcysteine bulk stands out for its reliable purity, application flexibility, regulatory compliance, and proven efficacy in pharmaceuticals, food, chemicals, and beyond. Industrial buyers, supplement brands, and R&D teams are encouraged to explore next-generation NAC solutions for sustainable value.
Contact us to discuss your tailored NAC project, request specification sheets, or gain technical support—from small batch custom formulations to global JIT supply.
Contact us to discuss your tailored NAC project, request specification sheets, or gain technical support—from small batch custom formulations to global JIT supply.
References & Further Reading:
[1] GrandView Research. (2023). Global N-Acetylcysteine Market Size.
[2] PharmaCompass NAC Supplier Directory: pharmacompass.com
[3] U.S. National Institutes of Health: NAC Factsheet & Safety
[4] Industry forum, EXPO: Global Market Trends
[5] PubMed. (2022). N-Acetylcysteine Applications Review: Clinical Uses of NAC
[1] GrandView Research. (2023). Global N-Acetylcysteine Market Size.
[2] PharmaCompass NAC Supplier Directory: pharmacompass.com
[3] U.S. National Institutes of Health: NAC Factsheet & Safety
[4] Industry forum, EXPO: Global Market Trends
[5] PubMed. (2022). N-Acetylcysteine Applications Review: Clinical Uses of NAC
