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N Acetyl L Cysteine Powder

1、English Name: N Acetyl L Cysteine
2、Specification: 99% HPLC
3、Appearance: White Crystalline Powder
4、CAS NO.: 131685-11-5
5、Lead time: 3-7 Working Days
6、Package: 12kg/drum, 27 drums/tray
7、Main Market: North America, Europe, Switzerland, South Africa, Southeast Asia, Australia, etc.
8、Certification: cGMP,Kosher, Halal, BRC, Organic, ISO9001, ISO22000, etc
9、Europe Warehouse/America Warehouse
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  • Product Description

cGMP-Certified N-Acetyl-L-Cysteine (NAC) API Powder for Respiratory & Detox Applications

If you require pharmaceutical-grade N Acetyl L Cysteine Powder for detoxification or lung treatment, N-acetyl-L-cysteine ​​(NAC), as a highly efficient endogenous rate-limiting precursor to glutathione (GSH), the body's core antioxidant barrier, can directly penetrate cell membranes. This overcomes the bioavailability challenge of traditionally orally administered glutathione, which is easily degraded in the gastrointestinal tract. It not only directly breaks free radical chains but also liquefies and dissociates thick mucopolysaccharide-protein complexes in the respiratory tract, restoring the lungs and trachea's natural ciliary detoxification function.

Our NAC powder, produced in a cGMP-certified factory in Shaanxi Hongda, boasts a purity of 99% or higher as determined by HPLC and comes with all necessary legal documentation, including a Certificate of Analysis (COA) for each batch. Whether you are manufacturing expectorants or custom-made APIs, we offer the fastest, most monitorable, and auditable material delivery cycle on the market.

 N-acetyl-L-cysteine powder

 

Why Choose Our N Acetyl L Cysteine Powder?

Global Compliance: It meets the requirements of USP, EP, JP, and ICH Q7, therefore it may be simply added to pharmaceuticals that the FDA or EMA have already authorized.

Unmatched Purity: Strict HPLC/GC testing demonstrate that heavy metals and particulates must be fewer than 10ppm and ≤0.1%.

Scalable Solutions: You may order 25 kilogram drums or 1,000 kg in bulk, and we'll send them from shops in the EU and the US the same week.

Customizable Formats: Change the container from a drum to a bag, and make sure the excipients fit well. The particles should be between 50 and 200 µm in size.

Micro-gas phase physical flavor shielding technology: During the fluidized bed crystallization stage, we embed trace amounts of natural high-molecular-weight dietary fiber onto the crystal surface in a multi-dimensional steric hindrance manner. This results in the bulk raw powder having only a very slight acidic taste and absolutely no unpleasant sulfurous odor, reducing the flavoring cost of oral liquids or instant beverage formulations by 70%.

Capsule-specific incompatible modification: Hongda provides a specialized, fully buffered, acid-free specification (achieved through scientific blending of extremely trace amounts of pharmaceutical-grade sodium carbonate or anhydrous sodium citrate), with crystal form exhibiting excellent biocompatibility with HPMC plant-based capsules or gelatin capsule shells.

Equipment

Product Specifications

ANALYSIS
SPECIFICATION
RESULTS
Appearance
white powder
Complies
Odor
Characteristic
Complies
Tasted
Characteristic
Complies
Assay
99.5%
Complies
Sieve Analysis
100% pass 80 mesh
Complies
Loss on Drying
5% Max.
1.02%
Sulphated Ash
5% Max.
1.3%
Extract Solvent
Ethanol & Water
Complies
Heavy Metal
5ppm Max
Complies
As
2ppm Max
Complies
Residual Solvents
0.05% Max.
Negative
Microbiology
 
 
Total Plate Count
1000/g Max
Complies
Yeast & Mold
100/g Max
Complies
E.Coli
Negative
Complies
Salmonella
Negative
Complies

 

Trusted by Pharmaceutical Leaders Across 50+ Countries

Respiratory Health Innovations

Our N Acetyl L Cysteine Powder is ideal for:

  • COPD & Asthma Medications: Enhances mucus clearance in 85% faster dissolution rates.
  • N-Acetylcysteine IV Solutions: Pre-tested for endotoxin levels (<0.25 EU/mg) and sterility.

Detoxification & Specialty Therapeutics

  • Acetaminophen Overdose Antidotes: 99.3% purity for rapid glutathione synthesis.
  • Renal Protection Adjuvants: Low-residue formula compatible with dialysis solutions.


Key Benefits of N-Acetyl L Cysteine

Respiratory Health Support: Studies have shown that NAC may help the lungs perform better and make respiratory issues like asthma and pneumonia less severe. It helps thin mucus and makes it easier to expel, providing relief for those suffering from chronic respiratory issues .

Detoxification: When NAC is present, the liver makes more glutathione, which helps it clean itself out.This makes it an excellent choice for individuals looking to support their body's natural detox pathways .

Cognitive Function: Studies have suggested that NAC may help improve cognitive function and memory, especially in individuals with neurodegenerative diseases such as Alzheimer's and Parkinson's .

Immune System Support: Because it is an antioxidant, NAC protects the immune system against reactive stress. It can also help reduce inflammation and support the body's natural defenses .

Mental Health: Some research indicates that NAC may help alleviate symptoms of depression and anxiety by balancing neurotransmitter levels in the brain .

N Acetyl L Cysteine Powder Benefts

 


How We Guarantee Your NAC Powder Quality

1. Supplier Audits: Partners that are ISO 22000 certified sent us raw materials.

2. Closed-Loop Synthesis: Made in clean rooms that are ISO Class 8 to protect germs from spreading.

certifications

3. Triple Testing: Each run identifies it (FTIR), purifies it (HPLC), and checks it for safety (microbial).

4. Full Documentation: You will get the CoA, MSDS, and DMF files within 24 hours.

Laboratory

Client Success Stories

“Hongdaherbs’ NAC powder met our ANDA submission requirements for a generic mucolytic drug. Their FDA DMF access streamlined our approval process.”

Quality Director, Indian Pharma Company

“Zero deviations in 3 years of sourcing. Their cold-chain logistics ensure perfect stability even to our Swiss facility.”

Procurement Head, European Biotech Firm

exhibitions

FAQ

1. Is your N Acetyl L Cysteine Powder made in cGMP-certified facilities?

Yes – our facilities are audited annually by third-party agencies (BRC, ISO 9001:2015).

2. Can I get a sample before bulk ordering?

We provide 100g free samples with CoA and stability data.

3. Do you assist with regulatory submissions?

Our team offers dossier templates and impurity profile reports for FDA/EMA filings.

4. How is batch traceability maintained?

Each batch has a unique QR code linking to synthesis records and QC results.

 

Ready to Streamline Your NAC Supply?

Contact our pharmaceutical team today:

📧 duke@hongdaherbs.com

Request a custom quote, schedule a facility audit, or discuss formulation optimization.

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