Product Name: Nattokinase
CAS Number: 9014-01-1
Molecular Weight: Approximately 27.7 kDa (27,700 Da)
Appearance: White to off-white powder
Nattokinase is a serine protease enzyme originally isolated from natto, a traditional Japanese fermented soybean food produced by Bacillus subtilis natto. It is a single-chain polypeptide composed of approximately 275 amino acid residues, with a molecular mass of about 27.7 kDa. The enzyme is typically obtained as a white to off-white lyophilized powder. It is soluble in water and aqueous buffers, forming clear to slightly opalescent solutions, and is practically insoluble in most organic solvents. Nattokinase exhibits optimal proteolytic activity under mildly alkaline conditions, generally around pH 8.0, and is active across a broad pH range. It is thermolabile and may lose activity upon prolonged exposure to elevated temperatures, typically above 50°C. As a serine protease, it catalyzes the hydrolysis of peptide bonds and demonstrates fibrinolytic activity by degrading fibrin and related proteins. It is used in dietary supplements, functional foods, and biochemical research. The material should be stored in a tightly closed container in a cool, dry, dark place, preferably refrigerated or frozen, to maintain enzymatic stability. It should be protected from moisture, heat, and strong oxidizing agents.
ITEMS | STANDARDS | RESULTS |
Description | White to almost white powder | White powder |
UV absorbance ratio | A250/A260 A280/A260 | 0.41-0.49 2.03-2.71 | 0.45 2.14 |
PH | 2.0-4.0 | 2.68 |
Loss on drying | ≤5.0% | 2.64% |
Assay (UV) | ≥98.0% | 99.17% |
Transmittance | ≥98.5% | 99.1% |
Heavy metals | ≤10ppm | <10ppm |
Purity (HPLC) | ≥98.0% | 99.6% |
Conclusion | It complies to the standard |
For regulatory compliance (e.g., USP, EP, JP), raw material Vidarabine must meet several rigorous standards:
-
Assay (by HPLC): 98.0% – 102.0% on an anhydrous basis.
-
Related Substances: Limits for specific impurities, notably Ara-Hx (NMT 2.0%), as well as any unspecified individual impurity (NMT 0.1%) and total impurities (NMT 2.0%).
-
Residual Solvents: Must comply with ICH Q3C guidelines (Class 1 and 2 solvents limited or absent).
-
Heavy Metals: NMT 20 ppm (typically lower for injectable grades).
-
Water Content (Karl Fischer): NMT 6.0% (the material is hygroscopic to a degree).
-
Microbial Limits: Total aerobic microbial count (TAMC) ≤ 1000 CFU/g, absence of S. aureus, P. aeruginosa, and Candida albicans.
As a high-purity pharmaceutical intermediate, L-Tyrosine Ethyl Ester Hydrochloride is predominantly utilized in the chemical synthesis of bioactive peptides, dopamine analogs, and melanin precursors. Its excellent solubility profile makes it an ideal chiral building block for asymmetric synthesis and a critical substrate in enzymatic reactions. Available in purity grades of ≥98% (HPLC), it meets stringent requirements for R&D and cGMP manufacturing processes. Reliable supply ensures batch-to-batch consistency for long-term project scalability.
Vidarabine is classified as a potential reproductive hazard and an irritant. Safety Data Sheets (SDS) mandate the following:
-
Hazard Statements (H360): May damage fertility or the unborn child (Category 1B).
-
Precautionary Measures: Use fume hoods and wear impermeable gloves (e.g., nitrile), lab coats, and safety goggles. Avoid generating airborne dust.
-
First Aid: In case of skin contact, wash immediately with copious soap and water. If inhaled, move to fresh air.
-
Storage: Store in tightly sealed, light-resistant containers at 2°C to 8°C (refrigerated) for long-term stability. Avoid freezing.
-
While superseded by newer nucleoside analogs (Acyclovir, Ganciclovir) for systemic use due to better bioavailability and lower toxicity, Vidarabine retains niche value. Its primary current application is ophthalmic ointment (3%) . Pharmacokinetically, the raw material has poor oral bioavailability (<10%) and is rapidly deaminated in the gastrointestinal tract, necessitating parenteral or topical administration.
Vidarabine API is a well-characterized, stable crystalline nucleoside analog. While its systemic use has declined, it remains a critical raw material for topical antiviral ophthalmic preparations, particularly where resistance to other agents occurs. Manufacturers must strictly control impurities (especially Ara-Hx) and water content to ensure final drug product efficacy.