Product Name: Pharmaceutical Grade Humic Acid
Description
Pharmaceutical Grade Humic Acid is a highly purified, standardized, bioactive macromolecular substance extracted from selected leonardite deposits and further refined through proprietary multi-stage purification processes to achieve exceptional purity and consistency required for pharmaceutical applications. It consists predominantly of humic acids (≥ 90% on dry basis) with a controlled fraction of fulvic acids and a complex matrix of oxygenated functional groups (carboxylic, phenolic, quinone, and ketone moieties).
- Chemical Nature: High-purity polymeric polyhydroxy acid of natural origin
- Intended Use: Active pharmaceutical ingredient (API), pharmaceutical excipient, detoxification adjuvant, antiviral agent, immunomodulator, permeation enhancer, mucoadhesive agent, and component in wound-healing and controlled-release formulations
1. Identification
- Synonyms : Pharmaceutical humic acid, medicinal-grade humic substances
2. Physical and Chemical Properties
| Property | Specification |
|---|---|
| Appearance | Dark brown to black fine powder |
| Odor | Slight characteristic earthy odor |
| Solubility in water (1% w/v) | Partially soluble, forms stable colloidal dispersion |
| Solubility in 0.1 N NaOH | ≥ 98% |
| pH (1% suspension in water) | 4.0 – 6.0 |
| Loss on Drying (105 °C, 3 h) | ≤ 5.0% |
| Ash Content | ≤ 2.0% |
| Total Humic Acid Content (dry basis) | ≥ 90.0% |
| Fulvic Acid Content | 5 – 20% (adjustable according to application) |
| Carboxylic Groups | ≥ 4.5 meq/g |
| Phenolic Groups | ≥ 2.0 meq/g |
| Heavy Metals (as Pb) | ≤ 10 ppm |
| Arsenic (As) | ≤ 1 ppm |
| Cadmium (Cd) | ≤ 1 ppm |
| Lead (Pb) | ≤ 2 ppm |
| Mercury (Hg) | ≤ 0.1 ppm |
| Total Aerobic Microbial Count | ≤ 100 CFU/g |
| Total Yeasts & Molds | ≤ 50 CFU/g |
| E. coli | Absent in 1 g |
| Salmonella | Absent in 10 g |
| Staphylococcus aureus | Absent in 1 g |
| Pseudomonas aeruginosa | Absent in 1 g |
| Bacterial Endotoxins (LAL) | ≤ 5 EU/mg (for parenteral-grade lots) |
| Particle Size (D90) | ≤ 50 µm |
3. Purity and Impurity Profile
- Sum of 16 EPA PAHs : ≤ 10 ppb
- Benzo[a]pyrene : ≤ 1 ppb
- Dioxins/Furans + dioxin-like PCBs : ≤ 1.0 pg WHO-TEQ/g
- Residual solvents : Complies with ICH Q3C (Class 3 or better)
- Pesticide residues : Complies with USP <561> and Ph. Eur.
4. Packaging
Double-lined pharmaceutical-grade PE bags in fiber drums or aluminum pouches with desiccant; available in 1 kg, 5 kg, 10 kg, and 25 kg units.
5. Storage and Stability
- Store in tightly closed containers protected from light and moisture at temperature ≤ 25 °C.
- Shelf life: 5 years from date of manufacture.
- Re-test interval: 60 months.
6. Regulatory & Documentation Support
- cGMP & ICH Q7 compliant manufacturing
- Type II or Type IV Drug Master File (DMF) available
- CEP preparation on request
- BSE/TSE-free, GMO-free, allergen-free, melamine-free statements
- Kosher & Halal certification available
- Full stability data (ICH conditions), impurity profiling, and technical package provided under confidentiality agreement
7. Key Pharmaceutical Applications
- Broad-spectrum antiviral activity (HIV, HSV, influenza, coronaviruses)
- Anti-inflammatory and immunomodulatory effects
- Heavy-metal and environmental toxin chelation
- Enhancement of mucosal permeability and bioavailability
- Stabilization of peptides, proteins, and nanoparticles
- Advanced wound healing and regenerative medicine formulations