Nystatin API | Antifungal Active Pharmaceutical Ingredient

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101
Call Now WhatsApp Quote

  • Nystatin API Overview

  • Nystatin is a polyene macrolide antifungal antibiotic produced through the fermentation of selected strains of Streptomyces noursei. It is a well-established antifungal active pharmaceutical ingredient used primarily in formulations for localized fungal infections, particularly those caused by susceptible Candida species.
  • Nystatin is pharmacopoeially defined as a mixture of substances, with Nystatin A1 as the main component. Because it is a fermentation-derived mixture rather than a conventional single-component synthetic compound, its pharmaceutical quality is principally evaluated through microbiological potency, identification, moisture, physical characteristics, and applicable purity and quality tests.
  • Nystatin demonstrates antifungal activity against a broad range of yeasts and yeast-like fungi. Its established pharmaceutical applications include oral, topical, mucosal, and other localized antifungal formulations.
  • Current U.S. labeling describes Nystatin as a polyene antifungal antibiotic obtained from Streptomyces noursei and identifies its mechanism as interaction with sterols in susceptible fungal cell membranes.

  • Chemical Information

  • Product Name: Nystatin
  • CAS Number: 1400-61-9
  • Molecular Formula: C₄₇H₇₅NO₁₇
  • Molecular Weight: 926.13 g/mol
  • Principal Component: Nystatin A1
  • Drug Class: Polyene Antifungal Antibiotic
  • Therapeutic Category: Antifungal
  • Molecule Type: Polyene Macrolide
  • Source: Streptomyces noursei
  • Physical Form: Yellow to light brown powder
  • Pharmacological Action: Antifungal
  • PubChem lists Nystatin under CAS 1400-61-9 with molecular formula C₄₇H₇₅NO₁₇ and molecular weight approximately 926.1 g/mol.

  • Nystatin Mechanism of Action

  • Nystatin acts primarily by interacting with sterols in the fungal cell membrane, particularly ergosterol.
  • The polyene structure of Nystatin enables it to bind to susceptible fungal membrane sterols. This interaction alters membrane permeability and results in leakage of intracellular components. The resulting membrane damage can inhibit fungal growth and may lead to fungal cell death.
  • Nystatin therefore exhibits both fungistatic and fungicidal activity in vitro, depending on the concentration and susceptibility of the organism. Current FDA labeling describes this sterol-binding mechanism and its resulting effect on fungal membrane permeability.

  • Pharmaceutical Applications of Nystatin

  • Nystatin API is widely used in the development and manufacture of antifungal pharmaceutical formulations.
  • Key applications include:
  • Oral antifungal formulations
  • Oral suspensions
  • Topical creams
  • Topical ointments
  • Topical powders
  • Mucosal antifungal formulations
  • Vaginal antifungal preparations
  • Dermatological formulations
  • Localized Candida infection treatment
  • Pharmaceutical antifungal research
  • Formulation development and analytical research
  • U.S. drug labeling documents Nystatin formulations containing 100,000 USP Nystatin Units per gram for topical ointments and 100,000 USP Nystatin Units per mL for oral suspensions. These are dosage-form strengths and should not be confused with the API potency specification.

  • Nystatin Physical Characteristics

  • Nystatin is generally described as a yellow to light brown powder. The International Pharmacopoeia describes it as very slightly soluble in water, sparingly soluble in ethanol and methanol, and practically insoluble in ether.
  • Important physical characteristics include:
  • Yellow to light brown powder
  • Polyene macrolide structure
  • Fermentation-derived pharmaceutical ingredient
  • Hygroscopic nature
  • Very slightly soluble in water
  • Sparingly soluble in ethanol
  • Sparingly soluble in methanol
  • Practically insoluble in ether
  • Sensitive to moisture and elevated temperatures

  • Nystatin Manufacturing Process

  • Nystatin is manufactured using a controlled microbial fermentation process involving suitable strains of Streptomyces noursei.
  • A pharmaceutical manufacturing process generally involves:
  • Selection and qualification of the production microorganism
  • Preparation of fermentation media
  • Inoculum development
  • Controlled fermentation
  • Monitoring of fermentation parameters
  • Recovery of fermentation broth
  • Separation of biomass and process materials
  • Extraction and concentration of Nystatin
  • Purification and removal of process-related substances
  • Controlled drying
  • Milling or particle-size adjustment when required
  • Potency determination
  • Identification and quality testing
  • Microbiological quality assessment
  • Controlled packaging and storage
  • Because Nystatin is a fermentation-derived mixture, control of the fermentation process and final potency is particularly important for achieving consistent pharmaceutical quality.

  • Nystatin Quality Control Testing

  • Nystatin requires specialized analytical and microbiological quality-control testing.
  • Important quality attributes include:
  • Identification
  • UV-Visible absorption characteristics
  • Microbiological potency
  • Loss on drying
  • pH where applicable to the pharmacopoeial test solution or suspension
  • Related substances where applicable
  • Microbiological quality
  • Residual solvents where applicable
  • Elemental impurities
  • Stability
  • Physical appearance
  • The International Pharmacopoeia specifies NLT 4,400 International Units/mg, calculated with reference to the dried substance. It also specifies loss on drying NMT 5.0% and a pH range of 6.5–8.0 under the prescribed test conditions.

  • Nystatin Potency

  • Unlike many conventional APIs, Nystatin is not best represented by a simple percentage HPLC assay.
  • The principal pharmacopoeial quality attribute is antimicrobial potency, expressed in Nystatin Units per mg.
  • For the International Pharmacopoeia:
  • Potency: NLT 4,400 International Units/mg, calculated with reference to the dried substance.
  • This potency-based approach is important when preparing the CMS specification for Nystatin.

  • Nystatin and Candida

  • Nystatin is particularly important in pharmaceutical formulations designed to manage infections caused by Candida species.
  • It has established activity against susceptible yeasts and yeast-like fungi, including Candida albicans. U.S. labeling describes Nystatin as both fungistatic and fungicidal in vitro against a range of susceptible yeasts and yeast-like fungi.
  • Nystatin does not demonstrate appreciable activity against bacteria, protozoa, or viruses according to current U.S. labeling.

  • Pharmaceutical Formulation Development

  • Nystatin API can be incorporated into different pharmaceutical dosage forms depending on the intended application and formulation requirements.
  • Common dosage forms include:
  • Oral suspension
  • Topical cream
  • Topical ointment
  • Topical powder
  • Oral formulations
  • Mucosal preparations
  • Vaginal formulations
  • Its limited gastrointestinal absorption and localized antifungal activity make Nystatin particularly useful for local treatment applications. U.S. labeling notes that gastrointestinal absorption following oral administration is insignificant and that most orally administered Nystatin is passed unchanged in the stool.

  • Storage and Handling

  • Nystatin is hygroscopic and can gradually degrade when exposed to humid conditions. The International Pharmacopoeia recommends keeping Nystatin in a tightly closed container, protected from light, at a temperature not exceeding 5°C.
  • Recommended handling considerations include:
  • Store in a tightly closed container
  • Protect from light
  • Minimize exposure to moisture
  • Maintain controlled temperature
  • Avoid unnecessary exposure to elevated temperatures
  • Use appropriate moisture-protective packaging
  • Maintain suitable environmental conditions during handling

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 5.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
Get Bulk Quote via WhatsApp