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Pharmaceutical Chemistry
Microcrystalline Cellulose
Formula:
(C6H10O5)n
GOST/CAS:
CAS 9004-34-6
Microcrystalline cellulose (highly purified structural modifier, excipient) is an indispensable agent for direct compression, binding, and filling in the pharmaceutical and encapsulation industries. It is a white or almost white, free-flowing powder that is practically insoluble in water and organic solvents. Due to its unique porosity and excellent compressibility, MCC ensures high tablet strength even at minimal compression force, while guaranteeing rapid disintegration within the body.
Applications
Direct Compression Tableting: Utilized as a primary dry binder and filler. It enables the tableting of moisture-sensitive and thermolabile Active Pharmaceutical Ingredients (APIs) without requiring a wet granulation stage.
Encapsulation & Filling: Applied as a highly efficient diluent (filler) in the production of hard gelatin capsules. It ensures uniform distribution of micro-doses of APIs and consistent capsule filling.
Disintegration Regulator: Facilitates rapid swelling and controlled breakdown of the tablet matrix in the gastrointestinal tract due to its capillary effect (moisture absorption), accelerating the release of active substances.
Suspensions & Emulsions: Colloidal grades are used as stabilizers and thickeners for liquid dosage forms, preventing sedimentation and phase separation of the final product.
Key Advantages
Ideal Compressibility: Exhibits unique plastic deformation properties, allowing the production of mechanically robust tablets with smooth surfaces, even at low binder concentrations.
Chemical Inertness: Does not react with most Active Pharmaceutical Ingredients (APIs), ensuring the stability and preservation of the therapeutic properties of the drug products.
Flowability Enhancement: The optimized particle size distribution reduces interparticle friction, improves the flow of powder blends, and prevents sticking to tablet press punches.
Biocompatibility & Safety: A completely non-toxic, hypoallergenic product of natural origin. Complies with the strict requirements of leading global pharmacopoeias (USP/NF, EP, BP, JP).
Storage & Transportation
- Store in dry, clean, cool, and well-ventilated warehouses in tightly sealed original packaging.
- Critical Note: Protect from moisture and humidity due to the highly hygroscopic nature of the product. Keep away from heat sources and strong odors.
- Transportation is permitted by all types of covered transport, provided temperature regulations are met and the product is shielded from precipitation.
- The product is non-hazardous and does not belong to any hazard class. Shelf life: 3 years from the date of manufacture.
Technical Specifications
Appearance
White or almost white, fine crystalline powder, odorless and tasteless
Molecular Weight
~ 36,000 g/mol
Assay (Core Substance)
≥ 97.0%
Bulk Density
0.26 – 0.32 g/cm³ (depending on the grade/particle size)
pH (10% aqueous suspension)
5.0 – 7.5
Loss on Drying
≤ 5.0%
Supply info
- Industrial multi-layer paper bags with a hermetic polyethylene inner liner, available in 20 kg or 25 kg.
- Supplied on pallets, securely wrapped with stretch/shrink-wrap to protect against moisture ingress.
- Tailored selection of specific grades based on particle size (e.g., equivalents to PH-101, PH-102) to meet individual manufacturing process requirements.