Red Rice Yeast Extract Monacolin K 0.2%

Red Rice Yeast Extract Monacolin K 0.2% | Natural Food Grade Colorant & Functional Ingredient 

Controlled fermentation of non-GMO rice with Monascus purpureus yields Red Rice Yeast Extract Monacolin K 0.2%. This violet-red fine powder has two food production uses:

Use natural colourants in processed meats and baked items.

Globally compliant functional ingredient for dietary supplements.

Our extract distinguishes itself from unstandardised red yeast rice powder by ensuring consistent Monacolin K content (≥0.2% by HPLC) and low Citrinin levels (<50 ppb).

Product Specifications

Primary Applications

1. Meat Processing (Natural Colorant)

Replace synthetic nitrites in cured meats

The target products include sausages, gammon, salami and bacon.

To get optimum colour intensity, use a typical dosage of 0.1-0.5%.

Performance: Stable at 70-85°C for 30 min. via pasteurisation.

Unique regulatory advantage: Meets US and EU clean label regulations.

Fine particles (80 mesh) guarantee homogeneous meat emulsion dispersion. In modest amounts of water or oil, pre-dissolve for best blending.

2. Bakery Products

Suitable For:

· Biscuits and cookies

· Specialty breads (e.g., red rice bread)

· Traditional fermented foods (e.g., red bean curd)

Heat Stability: Lasts 20 minutes at 180°C baking. Over beetroot red or anthocyanins in high-temperature applications.

For most dough compositions, pH 5.5-7.5 is stable.

3. Diet supplements

The 0.2% standard lets formulators use Monacolin K as a supporting ingredient without exceeding medicinal criteria.

Compliance with EU Regulation 2022/860: Formulas at 0.2% concentration can give <3mg Monacolin K per day dosage.

Combination: Cardiovascular health solutions often include plant sterols, CoQ10, or omega-3.

Quality Control & Safety

Citrinin Control Protocol

Citrinin (a nephrotoxic mycotoxin) is the primary safety concern in red yeast rice products. Our control measures:

1. Select custom Citrinin-free Monoscus strains.

2. Prevent Citrinin production with real-time temperature/humidity control during fermentation.

3. Batch Testing: HPLC-FLD - 5 ppb detection limit for each batch.

4. Specification: <50 ppb (far below EU limit of 2000 ppb for the food supplements).

Active Ingredient Verification

· Method: High-Performance Liquid Chromatography (HPLC) with UV detection at 238nm

· Reference Standard: Monacolin K acid form (CAS 75330-75-5)

· Acceptance Criteria: 0.20-0.30% (average: 0.25%)

Heavy Metals & Contaminants

All batches tested for:

· Lead (Pb): <2.0 ppm

· Arsenic (As): <1.0 ppm

· Cadmium (Cd): <1.0 ppm

· Mercury (Hg): <0.1 ppm

Pesticide residue screening per USP <561> (not detected for 230+ compounds)

Formulation Guidelines

Recommended Usage Levels

Stability Considerations

Temperature: Stable up to 100°C for 2 hours. Avoid prolonged heating above 180°C.

Light: Degrades under direct UV. Use opaque packaging for finished products.

pH: Most stable at pH 6-7. Significant fading occurs at pH >9 or <3.

Water Activity: Store at <0.6 aw to prevent microbial growth and color degradation.

Solubility & Dispersion

· Water: Insoluble (dispersible with agitation)

· Ethanol (95%): Partially soluble

· Oil: Dispersible in vegetable oils with lecithin (2-5%)

Best Practice: For aqueous systems, pre-disperse Red Rice Yeast Extract Monacolin K 0.2% in glycerin or propylene glycol at 1:3 ratio before adding to main formulation.

Regulatory Status

Americas

FDA Status: This ingredient is GRAS-approved for use as a food colourant (CFR 21, Section 73).

Dietary supplements are legal under DSHEA (1994) as long as they have the right labels.

GMP Compliance: Made in an NSF-approved facility

Union of Europe

Not a new food because it has been used for more than 25 years.

Limit for Monacolin K: Products can't have more than 3 mg/day of Monacolin K (Regulation 2022/860)

Labelling: Must have a warning for kids, pregnant women, and people who take statins.

Other Shops

Canada: a chemical that is NPN-eligible for heart health claims

Australia and New Zealand: drug listed in ARTG (no need for pre-market approval)

Japan: OK to add to food (Red Koji Colour, No. 102)

FAQ

Q: How are 0.2% and 3% Monacolin K concentrations different?

A: Applications that prioritise natural colouring and moderate functional characteristics use 0.2%. Pharmaceutical-regulated therapeutic supplements employ 1–5% concentrations. Our 0.2% product helps food makers comply with food-grade regulations.

Q: How can I calculate end product Monacolin K content?

A: Formula:

Monacolin K (mg/serving) = (Extract weight) × 0.002.

For example, a product with 500mg extract per serving yields 1mg Monacolin K each serving.

Q: Can this product replace sodium nitrite in meat processing?

A: It's red but doesn't have nitrite's antibacterial or curing properties. If you're removing synthetic nitrites, celery powder and fermented vegetable extracts are safe substitutes. This extract is colourant.

Q: What causes red yeast rice batch-to-batch colour variation?

A: Unstandardised goods differ because Monacolin K isn't tested—only colour value. Monacolin K and colour performance are constant across batches using our HPLC-standardized extract.

Q: Is Monacolin K "acid" or "lactone"?

A: Our extract has a balance of ~60% lactone and ~40% acid, depending on storage circumstances. Both forms of Monacolin K contribute toward total content, although the acid version is more bioactive. The difference isn't important for colouring.

Q: How should I keep opened product?

A: Seal securely after each usage. Keep in original packaging at 15-25°C away from light and moisture. Colour stability lasts 12 months after opening under ideal conditions.

Supply & Logistics

Ordering Information

· Minimum Order: 25 kg (one drum)

· Lead Time: 2-5 business days (in-stock items)

· Warehouses: California, Texas, New Jersey, Illinois

· Shipping: FOB warehouse or delivered (freight calculated separately)

Sample Policy

Free 100g samples available for qualified buyers. Requests processed within 24 hours.

To request a sample: Email your company details and intended application.

Documentation Provided

Each shipment includes:

· Certificate of Analysis (CoA)

· MSDS / SDS

· Kosher / Halal certificates (upon request)

· Allergen statement

· GMO-free declaration

About Earth Made Nutritions Inc.

Since 2018, we've specialized in fermented botanical extracts and natural colorants for the food and supplement industries. Our 12,000 sq ft GMP-certified facility in California operates under FSSC22000 standards.

Core Capabilities:

· Controlled fermentation technology

· HPLC/LC-MS analytical lab (ISO 17025 accredited)

· Custom extract development

· Regulatory support for US and international markets

Manufacturing Advantage: Unlike brokers, we control production from raw material selection through final packaging. This vertical integration ensures quality consistency and supply reliability.

Contact Us

Do you have more questions about Red Rice Yeast Extract Monacolin K 0.2%?

Email: info@em-herb.com