N-Acetyl-L-Cysteine powder

N-Acetyl-L-Cysteine Powder (NAC) - USP/EP Grade Raw Material 

Earth Made Nutritions sells USP and EP monograph-compliant N-Acetyl-L-Cysteine powder. We have manufactured raw materials for dietary supplement and pharmaceutical businesses in California since 2018.

Overview of Product:

• HPLC confirmed purity: ≥98.5%
• Form: White crystal powder
• Minimum order: 25kg
• Delivery: 2-day pickup from U.S. warehouses.
• Certifications: NSF GMP, ISO, FSSC22000, Kosher, Halal
• Test quality with a free sample.

Physical & Chemical Properties

Acylated L-cysteine, N-Acetyl-L-Cysteine powder, is more stable.

Typical traits:

Stable

For processing and storage, the acetyl group prevents thiol (-SH) oxidation. NAC is stable in pH 2-3 solutions but degrades over pH 7.

Solubility

At 200 mg/mL, water-soluble. Antioxidation needs pH regulation, however the powder dissolves easily in water.

See and smell

Due to the thiol group, it smells sulphurous. Odour intensification may suggest oxidation—contact us.

Visible Light

Rotation identifies the physiologically active L-isomer.

Key Technical Specifications

Manufacturing & Quality Control

Production Facility

Our 15,000 sq ft California facility operates under NSF GMP certification. We use synthetic production methods with fermentation-derived starting materials.

Quality Testing

Each batch undergoes:

· HPLC purity analysis

· Heavy metals testing (ICP-MS)

· Microbial contamination screening

· Optical rotation verification

· Residual solvent analysis

Every shipment includes a Certificate of Analysis with complete test results.

Certifications:

· NSF GMP Certified

· ISO 9001:2015

· FSSC 22000

· Kosher (OK Kosher)

· Halal (IFANCA)

Formulation Applications

NAC powder works across multiple dosage forms:

Capsules & Tablets

Standard 40-80 mesh flows through encapsulation equipment. Use magnesium stearate (0.5-1%) as a lubricant for direct compression.

Powdered Blends

Mix with antioxidants (vitamin C, selenium) for synergistic formulations. Common serving sizes range from 200-600mg.

Liquid Formulations

Requires stabilization in aqueous solutions:

· Maintain pH 2.5-3.5 with citric acid

· Add chelating agents (EDTA 0.01-0.05%)

· Consider nitrogen purging to exclude oxygen

· Use within 90 days after preparation

Effervescent Tablets

NAC reacts with carbonates to produce CO₂. Use enteric coating or separate compartments in dual-chamber designs.

Storage of Finished Products

Light-resistant packaging is essential. Blister packs perform better than bulk bottles for moisture-sensitive formulations.

Supply Chain & Logistics

U.S. Warehouse Network

We maintain inventory at four distribution centers:

· West Coast (California)

· Southwest (Texas)

· Midwest (Illinois)

· East Coast (New Jersey)

Order Fulfillment

· Minimum order quantity: 25kg

· Standard lead time: 2 business days for pickup

· Bulk orders (>500kg): Contact for scheduling

· International shipping: Available with extended lead times

Packaging Options

· Standard: 25kg fiber drums with double polyethylene liner

· Custom: Available upon request for large orders

Regulatory & Compliance

Our NAC powder meets requirements for:

United States

· FDA GRAS status for dietary supplements

· USP monograph specifications

· FCC Food Chemicals Codex

European Union

· European Pharmacopoeia (EP) standards

· Novel Food Regulation compliance (varies by member state)

Other Markets

· Japanese Pharmacopoeia (JP)

· Health Canada Natural Health Products Regulations

We provide regulatory support documentation including:

· Master File references

· Country-specific compliance letters

· Allergen statements

· BSE/TSE certificates

· Non-GMO declarations

FAQ

Q; What creates sulphur smell?

A: Thiol (-SH) smells distinctively. This is typical, real NAC. Proper packing reduces odours.

Q: Can I obtain less than 25kg?

A: Our minimum order is 25kg. Our product development samples are free up to 100g.

Q: What distinguishes USP and EP grades?

A: Each is highly pure. USP is for North America, EP for Europe. Both standards are met by our product.

Q: How to avoid manufacturing oxidation?

A: Air and moisture exposure should be limited. Work in low-humidity (<50% RH) settings with nitrogen blanketing for bulk processing.

Q: Are custom particle sizes available?

A: Yes, liquid suspensions have 80-120 mesh micronised versions. Custom milling takes 3-4 weeks.

Q: What documentation comes with each order?

A: · Certificate of Analysis

· Safety Data Sheet (SDS)

· Kosher/Halal certificates

· Non-GMO declaration

· Allergen statement

Company Background

Earth Made Nutritions Inc. has supplied raw materials to dietary supplement manufacturers since 2018. Our team includes food scientists and quality assurance specialists with backgrounds in pharmaceutical production.

We focus on amino acid derivatives, antioxidants, and specialty nutrients for the health products industry.

Our Approach:

· Direct manufacturer relationships

· Batch-to-batch consistency testing

· Technical formulation support

· Transparent documentation

Request Information

Do you have more questions about N-Acetyl-L-Cysteine powder?

Email: info@em-herb.com