Nystatin Powder CAS 1400-61-9 | ≥4400 IU/mg Polyene Antifungal API Manufacturer China

Key Selling Points

✓ First-In-Class Polyene Macrolide Antifungal - Discovered 1950, Gold Standard for Candida

✓ Ergosterol-Binding Membrane Disruptor - Forms Transmembrane Channels, Fungistatic & Fungicidal

✓ Oral Non-Absorbed GI Antifungal - Targets GI Tract Candida Without Systemic Exposure

✓ Well-Established Veterinary Use - Avian Crop Mycosis, Canine/Feline Candidiasis, FDA-Approved Turkey Feed

✓ Low-Cost Topical & Oral Antifungal - Suspensions, Ointments, Ear Preparations, Ophthalmic Formulations

✓ Research-Grade API - Potency-Verified (IU/mg), Full COA, Identity & Purity Documentation

What Is Nystatin Powder?

Nystatin Powder (CAS 1400-61-9, C₄₇H₇₅NO₁₇, MW 926.10) is the first-in-class polyene macrolide antifungal antibiotic, discovered in 1950 and produced by fermentation of Streptomyces noursei. It binds to ergosterol in fungal cell membranes, forming transmembrane channels that increase permeability and cause leakage of intracellular contents. It is primarily active against Candida species, with fungistatic activity at low concentrations and fungicidal activity at high concentrations.

Nystatin is widely used as a pharmaceutical and veterinary raw material for oral and topical antifungal formulations. Because it is not absorbed from the gastrointestinal tract, it is safely used for oral and GI candidiasis without systemic exposure. It is too toxic for parenteral use. In veterinary medicine, it is commonly used for avian crop mycosis, canine/feline oral and GI candidiasis, and Malassezia otitis (in combination ear preparations).

How Does Nystatin Powder Work?

Nystatin Powder exerts its antifungal effect by binding to ergosterol, the principal sterol in fungal cell membranes. This binding creates transmembrane pores that disrupt membrane integrity, causing leakage of potassium ions and other essential cellular components, ultimately leading to fungal cell dysfunction and death. It is fungistatic at low concentrations and fungicidal at high concentrations.

Because Nystatin Powder is not absorbed from the GI tract, oral administration produces only local antifungal effects in the gastrointestinal tract with minimal systemic toxicity. It is active primarily against Candida species and other yeasts, but is not effective against bacteria. It is too toxic for intravenous or systemic use due to potential nephrotoxicity, electrolyte imbalance and infusion-related reactions. Common oral side effects include nausea, vomiting, diarrhea and abdominal discomfort.

What Are the Applications of Nystatin Powder?

Human Medicine: Used in oral suspensions for oropharyngeal candidiasis (thrush), esophageal candidiasis and GI candidiasis; topical ointments for skin and vaginal candidiasis; ophthalmic preparations for fungal keratitis.
Veterinary Applications: Used for avian crop mycosis (300,000 IU/kg PO BID), FDA-approved medicated feed for turkey crop mycosis and mycotic diarrhea, canine/feline oral and GI candidiasis, and Malassezia otitis in combination ear preparations; also used in reptiles for GI fungal infections.
Antifungal Research: Applied in Candida susceptibility testing, antifungal activity screening, fungal membrane permeability studies and ion channel formation research.
Cell Culture: Used as a supplement in cell culture media to prevent fungal contamination (alongside penicillin-streptomycin).
Pharmaceutical Manufacturing: Serves as a raw material for oral suspensions, topical ointments, vaginal suppositories, ear drops and ophthalmic solutions.

What Is the Difference Between Nystatin and Other Polyene Antifungals?

Feature	Nystatin	Amphotericin B	Natamycin
CAS	1400-61-9	1397-89-3	7681-93-8
Polyene Type	Tetraene (4 double bonds)	Heptaene (7 double bonds)	Tetraene
Molecular Weight	926.10	924.09	665.74
Antifungal Spectrum	Candida (primary), limited other fungi	Broad (Candida, Aspergillus, Cryptococcus, Histoplasma)	Candida, Aspergillus, Fusarium (ocular)
Route	Oral (non-absorbed), topical	IV (systemic), topical, oral	Topical (ocular, skin)
Systemic Use	No (too toxic)	Yes (gold standard systemic antifungal)	No
Nephrotoxicity	Not applicable (not absorbed)	High (dose-limiting)	Not applicable
Typical Use	Oral/topical candidiasis, GI candidiasis, veterinary	Systemic fungal infections, leishmaniasis	Fungal keratitis, skin infections
Veterinary Use	Avian crop mycosis, canine/feline candidiasis, ear prep	Systemic mycoses, leishmaniasis	Fungal keratitis

How Does Nystatin Compare With Azole Antifungals?

Feature	Nystatin	Fluconazole	Itraconazole	Ketoconazole
CAS	1400-61-9	86386-73-4	84625-61-6	65277-42-1
Class	Polyene macrolide	Triazole	Triazole	Imidazole
Mechanism	Ergosterol binding, membrane disruption	Inhibits 14α-demethylase (ergosterol synthesis)	Inhibits 14α-demethylase	Inhibits 14α-demethylase
Spectrum	Candida (primary)	Broad (Candida, Cryptococcus)	Broad (Candida, Aspergillus, dermatophytes)	Broad (Candida, dermatophytes)
Oral Absorption	Not absorbed	Well absorbed	Variable (acid-dependent)	Well absorbed
Systemic Use	No	Yes	Yes	Yes (limited)
Drug Interactions	Minimal (not absorbed)	Moderate (CYP2C9)	Many (CYP3A4)	Many (CYP3A4, antiandrogenic)
Typical Use	Local/GI candidiasis	Systemic candidiasis, cryptococcosis	Systemic mycoses, dermatophytes	Topical/systemic candidiasis
Cost	Low	Moderate	High	Low-moderate

How Is Nystatin Powder Manufactured?

Nystatin Powder is produced through submerged fermentation of Streptomyces noursei, followed by extraction, purification and drying.

Spore Inoculum Preparation → Seed Culture → Submerged Fermentation (Streptomyces noursei ATCC 11455) → Mycelium Separation → Solvent Extraction → Precipitation → Purification (Chromatography / Recrystallization) → Vacuum Drying → Milling → Potency Assay (IU/mg) → Final QC → Light-Protected Packaging

HDM BIO controls key fermentation, extraction and purification parameters, and verifies potency (IU/mg) per batch to maintain consistent antifungal activity and quality.

Quality Specifications

Test Item	Standard	Typical Result
Appearance	Yellow to tan powder	Consistent
Potency (Bioassay)	≥4400 IU/mg	4800 IU/mg
Identity (IR / HPLC)	Conforms to reference standard	Confirmed
Loss on Drying	≤5.0%	2.5%
Residue on Ignition	≤1.0%	0.3%
Related Substances	Within specification	Pass
Heavy Metals	≤10 ppm	Compliant
Residual Solvents	Within specification	Pass
Microbial Limits	Within specification	Pass
Sterility (topical grade)	Sterile	Compliant

What Quality Control Tests Are Performed for Nystatin Powder?

Each batch undergoes multi-step quality control before release, including biological potency assay.

Raw Material QC → In-Process Fermentation Monitoring → Potency Bioassay (IU/mg, Candida albicans) → HPLC Assay → IR Identity Verification → Loss on Drying → Residue on Ignition → Related Substances → Heavy Metals → Residual Solvents → Microbial Limits → Sterility Test (topical grade) → Final Batch Release

Key evaluations include biological potency assay (≥4400 IU/mg against Candida albicans), HPLC assay, IR identity, loss on drying, residue on ignition, related substances, heavy metals, residual solvents, microbial limits, and for topical grade: sterility testing. Every commercial batch is supported by a batch-specific COA including potency results and relevant analytical documentation for incoming QC and supplier qualification.

What Factors Affect Nystatin Powder Bulk Price?

Nystatin Powder bulk pricing is driven by several key factors:

Fermentation Yield: Streptomyces noursei fermentation efficiency and nystatin A1 yield directly influence production costs.
Potency Grade: Higher potency (≥5000 IU/mg) and sterile/topical grade command a premium over standard bulk grade.
Sterility Specification: Aseptic processing and sterility-tested batches for topical/ophthalmic use carry higher production costs.
Regulatory Compliance & Certification: GMP-standard API with consistent COA and potency documentation demands a higher price.
Order Volume: Large-scale pharmaceutical contracts receive steeper per-kilogram discounts.
Logistics & Geography: Light-protected / cold-chain packaging and customs compliance add to the landed cost.

Contact HDM BIO for a current quotation and volume-based pricing.

Why Choose HDM BIO as Your Nystatin Powder Supplier?

High-potency (≥4400 IU/mg, typical 4800 IU/mg) polyene antifungal API for oral suspension, ointment, ear drop and ophthalmic formulations
Verified biological potency against Candida albicans, consistent identity and low impurities
First-in-class polyene macrolide with well-established oral non-absorbed GI antifungal profile
GMP-aligned fermentation production, ISO & HACCP certified quality system
Full batch traceability and complete documentation (COA including potency, MSDS, HPLC, sterility)
Flexible supply: kilogram samples to ton-level bulk API orders
Global export to 70+ countries with full customs support

Bulk Packaging, Shipping & Storage

Packaging: Foil bags for samples and moisture-proof fiber drums for bulk orders.
Custom Packaging: OEM labeling available.
Shipping Documents: COA, MSDS/SDS, commercial invoice, packing list and customs documentation available according to order requirements.
Storage: Store tightly sealed in a cool, dry, light-protected environment. Shelf life: 24 months.
Handling: For pharmaceutical/veterinary raw material use only; not for direct clinical administration.

Frequently Asked Questions About Nystatin Powder

Q1: What is Nystatin Powder?

A: Nystatin is the first-in-class polyene macrolide antifungal antibiotic, produced by fermentation of Streptomyces noursei. It binds to ergosterol in fungal cell membranes, forming pores that cause leakage of cellular contents. It is primarily active against Candida species. It is not absorbed from the GI tract and is too toxic for systemic use, so it is used orally for GI candidiasis and topically for skin/mucosal candidiasis.

Q2: What is the CAS number?

A: 1400-61-9 (nystatin A1).

Q3: How does nystatin work?

A: It binds to ergosterol in fungal cell membranes, creating transmembrane pores that disrupt membrane integrity and cause leakage of potassium and other essential components, leading to fungal cell death. It is fungistatic at low concentrations and fungicidal at high concentrations. It is not absorbed orally, acts locally in the GI tract, and is ineffective against bacteria.

Q4: What is nystatin used for?

A: Human: oral/GI candidiasis (thrush), esophageal candidiasis, vaginal/skin candidiasis (topical), fungal keratitis. Veterinary: avian crop mycosis, FDA-approved turkey medicated feed, canine/feline oral/GI candidiasis, Malassezia otitis (combination ear prep), reptile GI fungi. Research: antifungal screening, membrane permeability studies, cell culture fungal contamination prevention.

Q5: Is nystatin absorbed when taken orally?

A: No. Nystatin is not absorbed from the gastrointestinal tract after oral administration. It acts locally within the GI tract to treat fungal infections (such as oral and esophageal candidiasis) without producing significant systemic blood levels. This is why oral nystatin has a favorable safety profile with minimal systemic toxicity. It must not be used intravenously or systemically due to severe toxicity (nephrotoxicity, electrolyte imbalance).

Q6: What potency do you supply?

A: Standard ≥4400 IU/mg (USP biological potency assay against Candida albicans); typical batch result 4800 IU/mg. Higher potency and sterile/topical grade available on request.

Q7: Where can I buy it from China?

A: HDM BIO supplies bulk Nystatin Powder with batch COA (including potency assay) and global export support.

Q8: How much does Nystatin Powder cost?

A: Bulk pricing depends on fermentation yield, potency grade (standard vs high-potency), sterility specification, regulatory compliance, order volume and logistics. Contact HDM BIO for a current quotation.

Q9: Are there any safety concerns?

A: Oral nystatin is generally well tolerated (non-absorbed). Common: nausea, vomiting, diarrhea, abdominal discomfort. Topical: mild contact dermatitis. Rare: Stevens-Johnson syndrome. Ear preparations: rare transient deafness (elderly dogs), ataxia/tremor (cats). Contraindications: hypersensitivity. Must NOT be used parenterally (nephrotoxicity, hypokalemia). Solution is unstable - prepare fresh.

Q10: What is the difference between nystatin and fluconazole?

A: Nystatin is a polyene that binds ergosterol and disrupts membranes; not absorbed orally, local action only, primarily Candida. Fluconazole is a triazole inhibiting ergosterol synthesis; well absorbed, systemic, broader spectrum (Cryptococcus). Nystatin is low-cost for local/GI use; fluconazole for disseminated infections (CYP2C9 interactions).