Wholesale Mannitol Factory Price in USA

Mannitol CAS #69-65-8 plays a critical role in the pharmaceutical industry as an osmotic diuretic, excipient, and stabilizer. For buyers sourcing pharmaceutical-grade Mannitol at factory price in the USA, it is important to understand its source, manufacturing process, medical uses, formulation guidelines, dosage recommendations, and safety requirements.

Keywords: Pharmaceutical-grade mannitol, wholesale mannitol, mannitol factory price, bulk mannitol supplier.

This guide provides a full overview for pharmaceutical manufacturers and formulation specialists.

Source of Pharmaceutical Mannitol

Pharmaceutical-grade Mannitol is typically sourced through:

  • Natural extraction from plant materials like seaweed and fruits.
  • Industrial synthesis via hydrogenation of fructose, typically derived from corn starch.

Essence medchem Co., Ltd ensure ultra-high purity standards (≥99%) suitable for injectable, inhalable, and oral pharmaceutical applications.

Manufacturer Process of Mannitol

The production process includes:

1. Fructose Extraction: Starch hydrolysis yields high-fructose syrup.

2. Catalytic Hydrogenation: Fructose is hydrogenated under controlled conditions using a nickel catalyst.

3. Purification and Crystallization: Crystallization removes impurities, ensuring batch-to-batch consistency.

4. Drying, Milling, and Sieving: Produces the desired particle size for pharmaceutical formulations.

5. Compliant Packaging: Packed in controlled environments to preserve purity and sterility standards.

Our manufacturers comply with ICH Q7, USP, and EP standards.

Pharmaceutical Applications of Mannitol

1. Osmotic Diuretic Therapy

  • To reduce intracranial pressure (cerebral edema)
  • To lower intraocular pressure (glaucoma treatment)

2. Excipient in Solid Dosage Forms

  • As a filler or diluent in tablets and capsules
  • Enhances disintegration and mouthfeel in orally disintegrating tablets (ODTs)

3. Parenteral Preparations

Mannitol injections for emergency care (e.g., head trauma)

4. Inhalation Therapy

Dry powder inhalers for cystic fibrosis patients

5. Cryoprotectant

Protects cells and proteins during freeze-drying (lyophilization)

Dosage and Pharmaceutical Formulation

1. Intravenous Injection

  • 20% Mannitol solution
  • Adult dosing: 0.25–2 g/kg body weight

2. Oral Tablets

  • As an excipient: 10%–95% of tablet weight
  • In ODTs: 20%–80% concentration to improve taste and disintegration

3. Dry Powder Inhalers

Particle size optimized to 1–5 microns for deep lung delivery.

Formulation Tip: Mannitol non-hygroscopic nature improves tablet shelf-life and physical stability, making it a preferred choice over lactose in many drug products.

Safety and Regulatory Compliance

1. Pharmaceutical Mannitol is recognized as safe when used correctly:

  • GRAS (Generally Recognized As Safe) status by FDA
  • Listed in USP-NF, EP, JP, and other pharmacopeias
  • Minimal systemic toxicity
  • Common side effects at high doses include dehydration, electrolyte imbalance, or mild gastrointestinal upset.
  • Contraindicated in patients with anuria, severe dehydration, or active intracranial bleeding (except during craniotomy).

2. Strict quality control tests are mandatory, including:

  • Purity assay
  • Microbial limits
  • Endotoxin testing (for parenteral use)

We support Mannitol MOQ, Price per kg, specs, SDS. Request your bulk quotation now.

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