Vancomycin Hydrochloride is a pharmaceutical-grade glycopeptide antibiotic active pharmaceutical ingredient (API) used in the development and manufacture of antibacterial pharmaceutical formulations. It is the hydrochloride salt of vancomycin, a complex glycopeptide antibacterial substance produced by fermentation of Streptomyces orientalis. USP defines Vancomycin Hydrochloride based on its antibiotic potency, rather than a conventional percentage HPLC assay used for many small-molecule APIs. The current USP definition specifies a potency of not less than 900 µg of vancomycin per mg, calculated on an anhydrous basis.
Vancomycin Hydrochloride is identified by CAS No. 1404-93-9, molecular formula C66H75Cl2N9O24·HCl, and molecular weight 1485.71 g/mol. PubChem independently lists CAS 1404-93-9 and a molecular weight of approximately 1485.7 g/mol.
Vancomycin is an important antibacterial agent with activity primarily against susceptible Gram-positive bacteria. It is used in pharmaceutical products for serious bacterial infections where vancomycin therapy is appropriate. Vancomycin Hydrochloride is also used in oral pharmaceutical formulations for appropriate Clostridioides difficile infections.
The antibacterial activity of vancomycin is associated with inhibition of bacterial cell-wall synthesis. Because of its complex glycopeptide structure, the API is controlled using a combination of microbiological potency, chromatographic purity, physicochemical testing and impurity controls.
Vancomycin Hydrochloride is not a conventional single-component small molecule in the same sense as many synthetic APIs. USP describes it as the hydrochloride salt of a type of vancomycin or a mixture of two or more such salts. This is why potency expressed as µg/mg of vancomycin is particularly important for its pharmaceutical quality specification.
The API is generally described as a white to off-white or buff-colored powder and is hygroscopic. It is freely soluble in water, while its solubility in organic solvents is considerably lower. The Japanese Pharmacopoeia describes Vancomycin Hydrochloride as freely soluble in water, soluble in formamide, slightly soluble in methanol, very slightly soluble in ethanol and practically insoluble in acetonitrile.
Quality control of Vancomycin Hydrochloride involves several important attributes. These include identity, antibiotic potency, water content, residue on ignition, chromatographic purity and control of vancomycin-related components.
The USP specification establishes a minimum potency of 900 µg/mg as vancomycin on an anhydrous basis. This is the appropriate primary numerical specification for the API rather than entering an arbitrary assay range such as 98–102%.
A publicly available USP-based certificate of analysis for Vancomycin Hydrochloride reports a potency specification of NMT not applicable / minimum 900 µg/mg, a pH range of 2.5–4.5 for a 50 mg/mL solution, and water NMT 5.0% under its applicable specification.
The Japanese Pharmacopoeia similarly specifies 1000–1200 µg/mg potency on an anhydrous basis, water NMT 5.0%, and residue on ignition NMT 1.0%. Because different pharmacopoeias can define different potency specifications, the applicable compendial standard should be identified on the final CoA.
Swapnroop Drugs & Pharmaceuticals provides pharmaceutical API sourcing and supply support for Vancomycin Hydrochloride, serving pharmaceutical manufacturers and formulation-development organizations requiring glycopeptide antibacterial APIs.
As a Vancomycin Hydrochloride API manufacturer and supplier in India, the product can be positioned for pharmaceutical applications requiring controlled potency, identity, water content and impurity profile.
Typical supporting pharmaceutical documentation may include a Certificate of Analysis, product specification, batch analytical data, safety documentation, potency results, chromatographic purity data, water determination and stability information, as applicable.
Vancomycin Hydrochloride is hygroscopic and should therefore be protected from excessive moisture. Pharmaceutical-grade material should be maintained in suitable, tightly closed packaging under the storage conditions established by the applicable specification and stability program.
USP specifies preservation in tight containers.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 103.0% |
| Residue on Ignition | NMT 1.0% |
| pH (1% Solution) | 2.5–4.5 |
| Water Content | NMT 5.0% |