_1745918362135.webp)
N Acetyl L Cysteine Powder
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
- Product Description
cGMP-Certified N-Acetyl-L-Cysteine (NAC) API Powder for Respiratory & Detox Applications
If you need pharmaceutical grade N-acetyl-L-cysteine powder for detoxification or lung therapy, you need a partner who can help you understand, comply with regulations, and have the opportunity to move forward. NAC powder produced in Shaanxi Hongda's cGMP certified facility is 99% or higher pure based on HPLC testing, and our powder comes with all necessary legal documentation, including a Certificate of Analysis (COA) for each batch. Whether you are producing a mucolytic drug or a custom API, we offer the fastest, monitored, auditable material delivery cycle on the market.
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.
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 .
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.
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.
Our Certification
Our OEM Service
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
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:
Request a custom quote, schedule a facility audit, or discuss formulation optimization.
