Ultra-Pure L-Histidine HCl:
Blue Eyes Bio supplies EU-GMP certified L-Histidine HCl (CAS 71-00-1) compliant with Ph.Eur./USP/JP standards. Vital for monoclonal antibody production, infant nutrition, and hemodialysis formulations."
As a biologics-focused histidine supplier, we guarantee ultra-low nickel levels for cell culture media with full regulatory support for IND filings.
The product form of L-histidine is white powder crystals. It is an important amino acid API and a semi-essential amino acid for the human body. It is mainly used as a raw material for amino acid infusion and oral amino acid preparations. In addition, it is also an important drug for the treatment of heart disease, anemia, rheumatoid arthritis, gastrointestinal ulcers and substantial hepatitis, and its application in the medical field is becoming more and more extensive.
Uses of L-histidine: nutritional supplement, sweetener. Uses: used as a nutritional enhancer, an important component of amino acid infusion and compound amino acid preparations. It can be used to treat gastric ulcers. It is also used in biochemical research.
Parameter | Specification | Test Method |
Appearance | White crystalline powder | EP 2.2.1 |
Assay (HPLC) | 99.0-101.0% | USP <621> |
Specific Rotation | +12.4° to +14.4° | EP 2.2.7 |
pH (10% Solution) | 3.5-4.5 | Potentiometric |
Loss on Drying | ≤0.2% | EP 2.2.32 |
Residue on Ignition | ≤0.1% | USP <281> |
Heavy Metals (Pb) | ≤3 ppm | ICP-MS (ICH Q3D) |
Histidine-Related Impurities | ≤0.15% total | Ion Chromatography |
Endotoxins | <0.1 EU/mg (Biologics Grade) | USP <85> |
Nickel (Ni) | ≤1 ppm | EP 2.4.15 |
Transmittance | ≥98.0% (430nm) | EP 2.2.25 |
3. Core application scenarios
**Biopharmaceutical field**
- **Monoclonal antibody production**
✓ Critical buffer component of cell culture medium (maintain pH stability)
✓ Improve the accuracy of antibody folding (reduce aggregates)
- **Recombinant protein preparation**
✓ Lyoprotectant (synergistic with sucrose)
✓ Liquid preparation stabilizer
**Special medical nutrition**
- **Infant formula**
✓ Essential amino acids (special formula for premature infants)
✓ Comply with FDA 21 CFR 107.100/EU 2016/127
- **Kidney disease treatment**
✓ Essential component of peritoneal dialysis fluid (anti-fibrosis effect)
✓ Nutritional supplement for chronic kidney disease
**Innovative therapy**
- Gene therapy vector stabilizer · Peptide drug delivery system
+ **Ultra-low endotoxin control**
Proprietary chromatography purification technology (<0.1 EU/mg)
+ **Trace metal management**
Nickel content ≤1ppm (EP standard ≤5ppm)
+ **Biopharmaceutical customization**
Provide DSC thermal stability spectrum · Freeze-drying curve optimization support
+ **Global compliance support**
A: Yes, our biologics grade with controlled crystallinity (confirmed by XRD) minimizes reconstitution time. Request lyophilization study data.
Q: Is your histidine suitable for pediatric parenteral nutrition?A: Complies with EMA PDCO requirements for neonatal formulations. Provides specific heavy metal limits below standard pharmacopeia.