Dihydrostreptomycin is a semi-synthetic aminoglycoside antibiotic and pharmaceutical active ingredient derived from streptomycin. It has antibacterial activity against susceptible microorganisms and has historically been used in the treatment of certain bacterial infections.
Dihydrostreptomycin is identified by CAS No. 128-46-1. Its molecular formula is C21H41N7O12 and its molecular weight is approximately 591.61 g/mol.
Dihydrostreptomycin is an aminoglycoside structurally related to streptomycin. It exerts its antibacterial activity primarily through interaction with the bacterial 30S ribosomal subunit, interfering with protein synthesis.
Dihydrostreptomycin is bactericidal against susceptible bacteria. Its antibacterial activity results from disruption of bacterial protein synthesis and production of abnormal proteins.
Aminoglycoside activity is generally concentration-dependent, and susceptibility varies considerably among bacterial species.
Dihydrostreptomycin binds to the 30S ribosomal subunit of susceptible bacteria. This interferes with accurate translation of messenger RNA and leads to production of abnormal proteins.
The resulting disruption of bacterial protein synthesis contributes to the antibacterial effect.
Dihydrostreptomycin has historically been associated with treatment of susceptible bacterial infections and veterinary pharmaceutical applications.
Potential applications may include:
Use and regulatory status vary by country and product. Current approved indications should be verified with the relevant regulatory authority before commercial use.
Dihydrostreptomycin is relevant to pharmaceutical manufacturers and formulation-development organizations working with aminoglycoside antibiotics and antibacterial products.
The API may be incorporated into pharmaceutical formulations according to the approved formulation, dosage form, target organism and applicable regulatory requirements.
Dihydrostreptomycin API quality evaluation may include:
For antibiotic APIs, appropriate microbiological or potency testing may also be required depending on the applicable specification.
Dihydrostreptomycin intended for pharmaceutical manufacturing should comply with applicable GMP, quality-control and regulatory requirements.
The final API specification should correspond to the intended market, applicable pharmacopoeial requirements and the manufacturer's approved specification.
A batch-specific Certificate of Analysis (CoA) should provide relevant analytical results and acceptance criteria.
Dihydrostreptomycin should be stored in tightly closed, appropriately labelled containers under the manufacturer's recommended storage conditions. Protection from excessive heat, moisture and unsuitable environmental exposure should be maintained.
Dihydrostreptomycin is relevant to pharmaceutical organizations involved in antibacterial API sourcing, formulation development and veterinary pharmaceutical manufacturing, subject to applicable regulatory requirements.
For commercial applications, customers should verify the API form, grade, potency, assay, purity, impurity profile, microbiological quality, regulatory status and batch-specific CoA before use.
Consistent Dihydrostreptomycin API quality is important for reliable pharmaceutical formulation and manufacturing. Control of identity, potency, assay, purity and related substances supports reproducible product quality.
Appropriate documentation may include a Certificate of Analysis, specification sheet, safety documentation and applicable regulatory information.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Water Content | NMT 0.5% |
| Melting Point | 150°C – 154°C |