Pharmaceutical Chemistry

Potato Starch

Formula: (C₆H₁₀O₅)n GOST/CAS: CAS: 9005-25-8

Potato Starch (highly purified pharmaceutical excipient) is a natural biopolymer widely utilized in pharmaceutical manufacturing as a multifunctional excipient. The product is a fine, uniform, white to off-white, odorless, and tasteless powder, practically insoluble in cold water and ethanol. Due to its high chemical purity, biocompatibility, and hypoallergenic properties, potato starch is an indispensable component in the production of solid, semi-solid, and liquid dosage forms (tablets, capsules, ointments, and suspensions).

Applications

Tablet and Capsule Manufacturing (Disintegrant): Used as a highly effective disintegrant. Upon contact with biological fluids, the starch granules swell rapidly, ensuring rapid tablet disintegration and the subsequent release of the Active Pharmaceutical Ingredient (API).

Binding Agent (Granulation): Utilized in the form of starch paste (prepared by heating with water) as a binder in wet granulation processes. It provides the necessary granule strength and compressibility during tableting.

Filler and Diluent: Used to add bulk and mass to the tablet mixture when formulating low-dose or highly potent drugs, ensuring precise and uniform dosing.

Topical and Liquid Dosage Forms: Applied as a hydrophilic base, thickener, and stabilizer in the production of ointments, pastes, creams, dusting powders, and topical suspensions.

Key Advantages

Excellent Disintegration Performance Pharmaceutical-grade potato starch exhibits high capillary action and swelling capacity, guaranteeing that finished dosage forms fully comply with strict pharmacopeial disintegration testing requirements.

High Purity and Safety Profile The product undergoes a multi-stage purification process that eliminates foreign impurities, heavy metals, and pesticides. It is fully biodegradable, non-toxic, and non-allergenic.

API Compatibility and Stability Being chemically inert, potato starch does not interact with most active pharmaceutical ingredients, ensuring the chemical stability and integrity of the medication throughout its shelf life.

Optimized Technological Properties Features controlled moisture content and a strictly regulated particle size distribution, minimizing the risks of punch-sticking during direct compression.

Storage & Transportation

Multi-wall paper bags with a protective polyethylene inner liner of 25 kg (standard packaging for pharmaceutical raw materials).
Hermetically sealed Big-Bags of 500–1000 kg for large-scale industrial manufacturing.

Technical Specifications

Appearance White or almost white, fine, homogeneous powder; creaks distinctively when rubbed between fingers.

Solubility Practically insoluble in cold water and 96% ethanol. Forms a translucent or slightly opalescent paste when heated with water.

Loss on Drying (Moisture) ≤20.0% (in accordance with Pharmacopeia standards for potato starch)

pH (2% aqueous suspension) 5.0 – 8.0

Sulfated Ash ≤0.6%

Microbial Cleanliness Complies with international pharmacopeia standards for non-sterile dosage forms (absence of Salmonella, Escherichia coli, etc.).

Supply info

Store in dry, clean, well-ventilated warehouses, isolated from moisture and foreign odors, in tightly sealed original packaging.
Recommended storage temperature: +5 °C to +25 °C, with a relative humidity not exceeding 70%.
Avoid exposure to direct sunlight and contact with moisture (the product is highly hygroscopic).
Transportation can be carried out by all types of covered transport in compliance with standard freight regulations. The product is non-hazardous (not restricted under ADR regulations).
Shelf life — 2 to 3 years from the date of manufacture (depending on the manufacturer's specification).