Paromomycin API is an aminoglycoside antibiotic active pharmaceutical ingredient generally used in pharmaceutical products as Paromomycin Sulfate. Paromomycin is also known by synonyms such as Aminosidin, Aminosidine, Catenulin and Monomycin. The active moiety has the CAS Number 7542-37-2, while the pharmaceutical sulfate salt is commonly identified by CAS Number 1263-89-4.
For API and pharmaceutical product documentation, Paromomycin Sulfate is the appropriate form to identify when referring to the commonly used pharmaceutical salt. Paromomycin Sulfate has the molecular formula C23H47N5O18S and molecular weight approximately 713.70 g/mol. The free-base active moiety has the molecular formula C23H45N5O14 and molecular weight 615.63 g/mol.
Paromomycin belongs to the aminoglycoside antibiotic class and has both antibacterial and antiprotozoal applications. It is generally used as the sulfate salt for pharmaceutical formulations. Paromomycin acts by interfering with microbial protein synthesis through interaction with the bacterial ribosome. It has established applications in the treatment of certain intestinal protozoal infections and is also used in therapeutic approaches for visceral leishmaniasis.
Paromomycin Sulfate API is a sulfate salt associated with antibiotic substances produced by Streptomyces species. The USP monograph defines Paromomycin Sulfate as having a potency equivalent to not less than 675 µg of Paromomycin per mg, calculated on the dried basis. This is an important distinction because Paromomycin Sulfate is evaluated by a microbiological potency assay, rather than by simply assigning a conventional HPLC percentage assay.
The International Pharmacopoeia likewise specifies a minimum potency of 675 International Units of Paromomycin per mg, calculated with reference to the dried substance. The pharmacopoeial microbiological assay uses Bacillus subtilis as the test organism.
Paromomycin Sulfate is described pharmacopoeially as a powder and is very soluble in water. It is practically insoluble in ethanol and ether. The substance is hygroscopic, making appropriate moisture protection important during storage and handling.
Important pharmacopoeial quality parameters include:
The USP monograph specifies the specific rotation using a 50 mg/mL aqueous solution, while the pH test is performed using a 3% solution, not a 1% solution. Therefore, a CMS field specifically labelled “pH (1% Solution)” should not be populated with the 3% pharmacopoeial value as though it were a 1% test.
A qualified Paromomycin API Manufacturer in India should maintain appropriate controls throughout the manufacturing and purification process. As an aminoglycoside antibiotic produced through fermentation, Paromomycin requires suitable controls for production, recovery, purification, salt formation, drying and packaging.
Quality control should cover identity, microbiological potency, optical rotation, moisture, pH, residue on ignition and other applicable pharmaceutical quality attributes. Because the material is hygroscopic, protection from moisture is particularly important. The International Pharmacopoeia recommends protection from humid conditions and light.
Paromomycin Sulfate is used as an antibiotic and antiprotozoal pharmaceutical ingredient. Its applications include treatment of certain intestinal protozoal infections and use in treatment approaches for visceral leishmaniasis. Its mechanism involves interaction with ribosomal components and disruption of microbial protein synthesis.
Paromomycin API is therefore relevant to pharmaceutical manufacturing, formulation development, analytical testing and quality-control programs involving aminoglycoside and anti-infective products.
For commercial pharmaceutical applications, Paromomycin API should be supported by appropriate quality documentation, such as a Certificate of Analysis, specification sheet, analytical-method information and applicable regulatory documentation.
The API should be clearly identified as Paromomycin Sulfate, CAS 1263-89-4, when the sulfate salt is the intended pharmaceutical material. The free-base CAS 7542-37-2 should not be substituted for the sulfate salt in the primary CAS field. PubChem and pharmaceutical reference-standard sources support the distinction between the free base and sulfate form.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 2.0% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.0–7.5 |
| Specific Rotation | +50° to +55° |
| Solubility | Very soluble in water; practically insoluble in ethanol and ether |