MCC
CAS#: 9004-34-6
Standard: USP/BP/EP
Microcrystalline cellulose (MCC) is a purified, partially depolymerized cellulose derived from natural plant sources through acid hydrolysis. It is widely used as a pharmaceutical excipient due to its excellent compressibility, flowability, and biocompatibility. MCC serves as a multifunctional additive in oral solid dosage forms, including tablets, capsules, and granules, where it enhances formulation stability, drug release, and patient compliance.
|
Test Item |
Specification |
|
Appearance |
White or almost white, fine or granular powder |
|
pH |
5.0 - 7.5 |
|
Loss on drying % |
≤7.0 |
|
Residue on ignition % |
≤0.1 |
|
Water Soluble Substances % |
≤0.25 |
|
Ether Soluble Substances % |
≤0.05 |
|
Heavy Metal ppm |
≤10 |
(1) Direct Compression Tablets
Acts as a primary diluent and binder in formulations where drugs are sensitive to moisture or heat .
(2) Wet Granulation Binder
Serves as a dry binder in wet granulation processes, reducing the need for liquid binders.
(3) Disintegrant (Mild)
Facilitates rapid tablet breakup in the stomach or intestine, though less potent than superdisintegrants.
(4) Capsule Filler
Acts as a bulking agent in hard or soft gelatin capsules, ensuring consistent fill weight and content uniformity.
(5) Chewable Tablets
Enhances texture and mouthfeel, masking bitter tastes of APIs.
(6) Coating Carrier
Serves as a substrate for film-coating suspensions, improving adhesion and reducing coating defects.
Package: 20kg/Bag
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