Rutin NF11

Rutin NF11 (95% Purity) | Pharmaceutical Grade Supplier 

Earth Made Nutritions Inc. supplies pharmaceutical-grade Rutin NF11 meeting National Formulary 11 specifications. Based in California, we maintain US warehouses with ready stock for 2-day delivery.

Current Stock Status:✓ Available |Lead Time:2 days |MOQ:25kg

Why Pharmaceutical Manufacturers Choose Our Rutin NF11?

1. NF11 Monograph Compliance

Our product meets strict National Formulary 11 requirements:

· Purity:≥95% by HPLC

· Related substances:Quercetin <0.5%, Isorhamnetin controlled

· Heavy metals:Pb <0.5ppm, As <0.5ppm, Cd <0.2ppm, Hg <0.1ppm (ICP-MS verified)

· Microbial limits:TAMC <1,000 cfu/g, negative forE. coliandSalmonella

2. Superior Processing Performance

Flowability optimized for high-speed production with Rutin NF11.

· Controlled moisture content prevents caking

· Uniform particle size distribution (D50: 80-120μm)

· Excellent compressibility for direct tableting

Shelf life:24 months when stored in sealed containers, protected from light and moisture.

3. US-Based Inventory & Fast Delivery

· 4 warehouse locationsacross the United States

· Current stock:Available for immediate shipment

· Pickup time:2 business days

· No customs delaysor international shipping complications

4. Technical Documentation Included

Each batch ships with:

· Certificate of Analysis (CoA) with full HPLC chromatogram

· Heavy metal test report (ICP-MS)

· Microbial test results

· Residual solvent analysis (<5000ppm ethanol, GC verified)

· MSDS and allergen statement

· Kosher/Halal certificates

Technical Properties

Solubility Profile

· Water:Sparingly soluble (increases with temperature)

· Ethanol:Sparingly soluble

· Alkaline solutions:Highly soluble (pH-dependent)

· Acetone:Insoluble

Application note: pH adjustment to 8-9 enhances solubility for liquid formulations.

Key Functional Attributes

Applications in Pharmaceutical & Nutraceutical Products

Common Formulation Types

✓ Tablets (direct compression or wet granulation)

✓ Hard gelatin capsules

✓ Powder blends for stick packs

✓ Intermediate for Troxerutin synthesis

Typical Use Levels

· Dietary supplements:50-500mg per serving

· Pharmaceutical preparations:Per formulation requirements

· Cosmetic applications:0.1-1% (topical)

Formulation Support Available

Our R&D team provides:

· Dissolution rate optimization guidance

· Excipient compatibility data

· Stability study protocols

· Regulatory documentation support

Product Specifications

Quality Assurance Process

Multi-Stage Testing Protocol

Raw Material Screening

· Botanical identity verification (microscopy + DNA barcoding)

· Pesticide residue screening (>450 compounds, GC/LC-MS/MS)

· Initial purity assessment

In-Process Controls

· Real-time HPLC monitoring during extraction

· Solvent recovery verification

· Crystallization purity checks

Final Product Release Testing

· HPLC purity assay (validated per ICH Q2)

· Heavy metals panel (ICP-MS)

· Microbial enumeration and pathogen screening

· Particle size analysis (laser diffraction)

· Residual solvent quantification (GC-FID)

Stability Program

· Accelerated and long-term stability data available upon request

· Supports 24-month shelf life claim

Pricing & Order Information

What's Included

✓ Free sample (50-100g) for qualified customers

✓ Complete analytical documentation

✓ Technical consultation with R&D team

✓ Regulatory support for submissions

Custom packaging available for orders >200kg

FAQ

Q: How does NF11 grade rutin extract differ from standard?

A: The NF11 certification ensures pharmaceutical-grade purity (≥95%), controlled contaminants, and batch-to-batch uniformity. Standard extracts are 50-90% pure and vary in quality.

Q: Do you give batch-specific stability data?

A: Yes. Accelerated stability data (40°C/75% RH for 6 months) is included in each batch You can obtain long-term data for regulatory filings.

Q: What is your current lead time?

A: We send in-stock goods in 2 business days from our nearest warehouse. Packaging may take 5-7 days.

Q: Can you offer clinical trial materials?

A: Yes. We record clinical-grade material with complete traceability and improved testing processes.

Q: What sample size do you offer?

A: Qualified pharmaceutical and nutraceutical businesses receive 50-100g samples gratis. Shipping fees may apply.

Q: Does your facility have FDA approval?

A: Our NSF GMP-certified production facility has FDA-compliant dietary supplement paperwork.

About Earth Made Nutritions Inc.

Since 2018, we've specialized in sourcing and supplying high-purity botanical extracts for the pharmaceutical and nutraceutical industries.

Our Facility

· Location:Chino, California (primary warehouse)

· Capacity:Climate-controlled storage for 500+ tons

· Equipment:HPLC, GC, ICP-MS, microbiology lab

· Compliance:NSF GMP, FSSC 22000, ISO 9001

Our Commitment

We serve formulators who demand consistent quality, reliable supply, and responsive technical support. Every product undergoes rigorous testing before release.

Quality Policy:Zero tolerance for adulteration. Full traceability from farm to final packaging.

Contact Us

Do you have more questions about Rutin NF11?

Email: info@em-herb.com