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Technical Resource · AMBICEL Series

Microcrystalline Cellulose (MCC)
Complete Technical Guide

The world's most trusted pharmaceutical excipient — tablet binder, diluent, disintegrant, food additive E460(i), and cosmetic ingredient. Manufactured by Maple Biotech under WHO-GMP since 1982.

AMBICEL MCC 101 AMBICEL MCC 102 AMBICEL MCC 112 AMBICEL MCC 200 AMBICEL MCC 301 AMBICEL MCC 302 USP/NF · Ph.Eur · BP · JP E460(i) Food Grade WHO-GMP Certified
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What is Microcrystalline Cellulose (MCC)?

Microcrystalline Cellulose (MCC) is a purified, partially depolymerised form of cellulose derived from high alpha-cellulose content wood pulp or cotton linters. The manufacturing process involves treating cellulose with dilute mineral acid under controlled conditions (acid hydrolysis), which removes the amorphous regions and leaves the highly crystalline cellulose chains — giving MCC its distinctive properties as a white, odourless, free-flowing powder.

MCC is chemically inert, physiologically inert, and non-digestible in humans. It is one of the most versatile excipients in pharmaceutical formulation, a recognised food additive (E460i) in over 100 countries, and a functional ingredient in cosmetics under the INCI name MICROCRYSTALLINE CELLULOSE.

Chemical Identity

  • CAS No.: 9004-34-6
  • EINECS: 232-674-9
  • Molecular formula: (C₆H₁₀O₅)ₙ
  • Degree of polymerisation: 200–300
  • Crystallinity: ~70–80%
  • Source: Wood pulp / Cotton linters

Regulatory Identities

  • USP/NF: Microcrystalline Cellulose
  • Ph.Eur: Cellulosum microcristallinum
  • BP: Microcrystalline Cellulose
  • INCI: MICROCRYSTALLINE CELLULOSE
  • E Number: E460(i)
  • CFR: 21 CFR 182.90 (GRAS)

Physical Characteristics

  • Appearance: White/off-white fine powder
  • Odour: Odourless
  • Taste: Tasteless
  • Solubility: Insoluble in water
  • pH (10% slurry): 5.0–7.5
  • Bulk density: 0.25–0.45 g/cm³ (grade-dependent)

Key Functions

  • Tablet binder (dry and wet)
  • Tablet diluent / filler
  • Disintegrant (wicking mechanism)
  • Capsule diluent / lubricant
  • Food texturiser / fat replacer
  • Cosmetic binder / bulking agent

AMBICEL MCC Grades — Full Comparison

Maple Biotech offers six AMBICEL MCC grades, each engineered for specific formulation requirements. Selecting the right grade optimises tablet hardness, disintegration time, content uniformity, and manufacturing efficiency.

Grade Particle Size (µm) Bulk Density (g/mL) Moisture (NMT %) Key Feature Best For
AMBICEL MCC 101 Most Popular ~50 µm 0.28–0.33 5.0% General purpose, versatile binder Wet granulation, capsule filling
AMBICEL MCC 102 ~100 µm 0.28–0.33 5.0% Larger particle size, better flowability Direct compression, high-speed tableting
AMBICEL MCC 112 ~50 µm 0.28–0.34 1.5% Low moisture — moisture-sensitive APIs Aspirin, effervescent, hygroscopic drugs
AMBICEL MCC 200 DC Premium ~180 µm 0.29–0.36 5.0% Largest particle, superior flow Direct compression, large tablets
AMBICEL MCC 301 ~50 µm 0.28–0.34 5.0% Silicified (SMCC) — 2% SiO₂ Challenging APIs, low-dose potent drugs
AMBICEL MCC 302 ~100 µm 0.28–0.34 5.0% Silicified DC grade — best flow + binding Direct compression of problematic APIs

MCC 101 — The Workhorse

The most widely used MCC grade globally. MCC 101's ~50 µm particle size makes it the standard choice for wet granulation, where particle size is controlled during granulation. Also widely used for capsule filling as a diluent and lubricant.

MCC 102 — Direct Compression

Larger particle size (~100 µm) gives MCC 102 superior flowability and compressibility — critical for direct compression (DC) tablet manufacturing. The preferred grade for high-speed rotary tablet presses handling 100,000+ tablets/hour.

MCC 112 — Low Moisture

With moisture content NMT 1.5% (vs 5.0% for standard grades), MCC 112 is engineered for moisture-sensitive active ingredients. Ideal for aspirin tablets, effervescent formulations, vitamin C tablets, and hygroscopic APIs that degrade in the presence of water.

MCC 200 — Premium DC Grade

The largest particle MCC grade (~180 µm) with the highest bulk density and best powder flow properties. MCC 200 enables direct compression of large-format tablets (800 mg to 1500 mg) where excellent flow and uniform die filling are essential.

MCC 301 — Silicified (SMCC)

MCC co-processed with 2% colloidal silicon dioxide (Aerosil/Cab-O-Sil). The silicification process physically bonds SiO₂ to MCC surfaces, providing dramatically improved flow for cohesive, problematic APIs. Better compressibility at lower punch forces protects tablet press tooling.

MCC 302 — Silicified DC Grade

Combines the larger particle size of MCC 102 with silicification for the best of both worlds — excellent flow and compressibility. The recommended grade for direct compression of potent, low-dose APIs where content uniformity is paramount.

MCC in Pharmaceutical Manufacturing

Microcrystalline Cellulose is the most widely used pharmaceutical excipient in oral solid dosage form (OSD) manufacturing. Its unique combination of properties — compressibility, flowability, self-lubricating nature, and intrinsic disintegration — makes it indispensable in tablet and capsule manufacturing worldwide.

Tablet Manufacturing Applications

Direct Compression (DC)

MCC 102, 200, 301, 302 enable tableting without granulation — fastest, most economical tablet manufacturing method.

Wet Granulation

MCC 101 is the standard binder in high-shear and fluid-bed wet granulation, providing excellent inter-particulate bonding.

Dry Granulation / Roller Compaction

MCC grades with high compressibility enable dry granulation for moisture-sensitive APIs via ribbon/slug formation.

Orally Disintegrating Tablets (ODT)

Low MCC concentrations combined with super-disintegrants enable tablets that disintegrate in <30 seconds in the mouth.

Chewable Tablets

MCC provides the necessary mechanical strength and pleasant mouthfeel for chewable tablet formulations — vitamins, antacids, paediatric medicines.

Effervescent Tablets

MCC 112 (low-moisture grade) is critical for effervescent formulations containing citric acid/sodium bicarbonate mixtures.

Bilayer Tablets

MCC's excellent compressibility at low punch forces makes it ideal for bilayer tablets combining immediate and sustained release layers.

Film-Coated Tablets

MCC produces hard, smooth tablet cores with minimal friability — essential for tablets receiving aqueous or organic film coatings.

Modified Release

MCC is used in matrix tablets for extended release and in pelletisation (extrusion/spheronisation) for multiparticulate systems.

Hard Capsule Filling

MCC 101 as capsule diluent provides excellent flowability for automatic capsule filling machines and acts as a mild lubricant.

Pellets (Extrusion-Spheronisation)

MCC is the essential spheronising aid in pellet manufacturing — enables production of dense, spherical pellets for multiunit dosage forms.

Topical / Nasal

Colloidal MCC (microcrystalline cellulose gel) used in topical suspensions, nasal sprays, and ophthalmic formulations as a viscosity modifier.

Active Pharmaceutical Ingredient (API) Applications

MCC is compatible with the vast majority of APIs and is used extensively in formulations containing:

Analgesics & NSAIDs

  • Paracetamol (acetaminophen) tablets 500 mg, 650 mg
  • Ibuprofen 200 mg, 400 mg, 600 mg tablets
  • Aspirin / Acetylsalicylic acid (with MCC 112)
  • Naproxen, Diclofenac, Indomethacin
  • Celecoxib, Meloxicam tablets

Cardiovascular

  • Amlodipine, Atorvastatin, Rosuvastatin
  • Metoprolol, Atenolol tablets
  • Losartan, Valsartan, Olmesartan
  • Aspirin 75 mg / 150 mg cardiac tablets
  • Clopidogrel, Warfarin

Antibiotics & Anti-infectives

  • Amoxicillin, Amoxicillin-Clavulanate
  • Azithromycin, Clarithromycin
  • Ciprofloxacin, Levofloxacin
  • Metronidazole, Tinidazole
  • Doxycycline, Tetracycline

Metabolic / Diabetes

  • Metformin 500 mg, 850 mg, 1000 mg
  • Glibenclamide, Glipizide, Gliclazide
  • Sitagliptin, Vildagliptin tablets
  • Empagliflozin, Dapagliflozin
  • Pioglitazone, Rosiglitazone

Vitamins & Supplements

  • Vitamin C (ascorbic acid) chewable & effervescent
  • Vitamin D3, B-complex tablets
  • Iron, Calcium, Magnesium tablets
  • Multivitamin tablets
  • Zinc, Selenium tablets

CNS / Neurological

  • Carbamazepine, Phenytoin tablets
  • Sertraline, Fluoxetine, Escitalopram
  • Alprazolam, Clonazepam ODT tablets
  • Levodopa-Carbidopa (Parkinson's)
  • Donepezil, Memantine

Customer Types We Serve

Generic Pharmaceutical Manufacturers

WHO-GMP certified AMBICEL MCC for generic tablet and capsule production. CoA, TDS, MSDS, and DMF support provided. Available in 25 kg bags to multi-MT container loads.

Contract Development & Manufacturing (CDMO/CMO)

Technical grade selection support, formulation trials, and dedicated account management for CDMOs formulating innovative drug products.

API Manufacturers

Pharmaceutical-grade MCC for API tableting and pre-formulation research. Regulatory files including CEP, US-DMF, and EDMF available.

R&D / Formulation Scientists

Sample quantities from 100 g to 5 kg available for formulation development. Technical support from Maple Biotech's experienced formulation team.

MCC as a Food Ingredient — E460(i) Applications

Microcrystalline Cellulose is approved as a food additive worldwide, designated E460(i) in the EU and classified GRAS (Generally Recognized As Safe) by the US FDA under 21 CFR 182.90. As a food-grade ingredient, MCC functions as a fat replacer, dietary fibre source, anti-caking agent, emulsion stabiliser, texture modifier, and bulking agent.

Bakery & Confectionery

  • Low-fat and reduced-calorie cakes, biscuits, cookies
  • High-fibre bread and bread improvers
  • Fat replacer in cream fillings and icings
  • Anti-staling agent in baked goods
  • Dietary fibre enrichment in bakery products
  • Gluten-free bakery (improved texture)
  • Confectionery coatings, sugar panning

Dairy & Alternatives

  • Low-fat ice cream (fat replacer, creamy texture)
  • Yoghurt stabiliser (prevents syneresis)
  • Cheese — shredded cheese anti-caking agent
  • Whipped cream stabilisation
  • Plant-based dairy alternatives (oat milk, almond milk)
  • Vegan cheese texturiser
  • High-protein dairy beverages

Beverages

  • Protein shakes and meal replacement drinks
  • Low-calorie beverage stabiliser
  • Cocoa drink anti-settling agent
  • Fibre-fortified beverages
  • Smoothie viscosity modifier
  • Powdered beverage bases (anti-caking)
  • Sport and energy drink formulations

Sauces, Dressings & Condiments

  • Low-fat mayonnaise (fat replacer)
  • Salad dressing emulsion stabiliser
  • Ketchup and tomato sauce texturiser
  • Low-calorie gravies and soups
  • Cream-based sauces (reduced cream)
  • Processed cheese sauce thickener
  • Marinade and dip stabilisation

Plant-Based & Vegan Foods

  • Meat analogue (texturiser, binder)
  • Vegan burger patties (moisture retention)
  • Plant-based sausages, nuggets
  • Vegan egg replacer blends
  • Tofu texture improvement
  • Plant-based fat structure
  • Clean-label vegan products

Functional & Health Foods

  • Dietary fibre enrichment (insoluble fibre)
  • Calorie reduction (bulking agent)
  • Diabetic-friendly foods (low GI)
  • Weight management foods
  • High-fibre cereals and muesli bars
  • Functional nutrition bars
  • Fortified snack foods

MCC Food Additive Regulatory Status

RegionStatusDesignationMax Level
European UnionApproved Food AdditiveE460(i)Quantum Satis (QS)
United States (FDA)GRAS21 CFR 182.90As needed
Codex AlimentariusApprovedINS 460(i)GMP
India (FSSAI)ApprovedINS 460(i)GMP
JapanApproved (JSFA)微結晶セルロースGMP
China (NHSA)ApprovedGB 2760GMP
Australia/New ZealandApprovedINS 460(i)GMP

MCC in Cosmetics — INCI: MICROCRYSTALLINE CELLULOSE

Microcrystalline Cellulose is a versatile cosmetic ingredient approved by regulatory bodies in the US (FDA 21 CFR), EU (Annex III), and globally. In cosmetics, MCC functions as a binder, bulking agent, absorbent, viscosity-increasing agent, and texture enhancer across a wide range of personal care product categories.

Colour Cosmetics

  • Pressed powder foundations (binder, slip agent)
  • Compact face powders (oil absorption)
  • Eye shadows (binder, texture)
  • Blushers and bronzers
  • Setting powders (sebum control)
  • BB creams and CC creams
  • Liquid foundations (rheology modifier)

Skincare

  • Facial moisturisers (rheology modifier)
  • Sunscreen formulations (emulsion stabiliser)
  • Anti-ageing serums and creams
  • Exfoliating scrubs (mild abrasive)
  • Sheet masks (cellulose substrate)
  • Oil-free moisturisers (oil absorber)
  • Tinted moisturisers

Hair Care

  • Dry shampoos (oil absorption)
  • Volumising hair powders
  • Hair styling pastes (binder)
  • Scalp treatments
  • Hair mask thickeners
  • Anti-dandruff product stabiliser
  • Texturising hair sprays

Personal Care

  • Toothpaste (mild abrasive, binder)
  • Deodorant sticks (binder)
  • Talcum powder alternatives
  • Baby powder formulations
  • Feminine hygiene products
  • Body powder formulations
  • Intimate care products

For cosmetic and OEM/ODM manufacturers, AMBICEL MCC is available with HALAL and KOSHER certificates, full INCI declaration, safety data sheet (SDS), and detailed technical specifications in compliance with EU Cosmetics Regulation 1223/2009 and US FDA 21 CFR Part 700.

MCC in Nutraceuticals and Dietary Supplements

The dietary supplement and nutraceutical industry is one of the fastest-growing end markets for pharmaceutical-grade MCC. AMBICEL MCC is widely used in supplement tablet and capsule manufacturing globally, from single-vitamin products to complex multi-ingredient formulations.

Supplement Tablets

  • Vitamin C 500 mg / 1000 mg tablets
  • Vitamin D3 + K2 combination tablets
  • B-complex tablets
  • Omega-3 (fish oil) tablets
  • Multivitamin and multimineral tablets
  • Probiotics tablets (MCC 112 for stability)
  • Herbal extract tablets (curcumin, ashwagandha)

Capsule Formulations

  • Herbal supplement capsules
  • Protein and amino acid capsules
  • Adaptogen blends (ashwagandha, rhodiola)
  • Nootropic supplement capsules
  • Ayurvedic formulations in capsules
  • Pre/probiotic capsules
  • Weight management supplements

Paediatric & Senior Supplements

  • Chewable vitamin tablets for children
  • Gummy-alternative chewable tablets
  • Calcium + D3 tablets for elderly
  • Iron supplements for children
  • Paediatric probiotic tablets
  • Senior multivitamin tablets
  • Bone health supplements

Sports Nutrition

  • Creatine monohydrate tablets
  • BCAA tablets
  • Pre-workout tablets
  • Recovery supplement tablets
  • Electrolyte tablets
  • Weight loss supplement tablets
  • Testosterone support tablets

Technical Properties of Microcrystalline Cellulose

Understanding MCC's physicochemical and functional properties is essential for optimal formulation design. The following properties make MCC uniquely valuable across pharmaceutical, food, and cosmetic applications.

Compressibility

MCC exhibits exceptional plastic deformation under compression pressure. This plastic flow allows MCC particles to deform and interlock, producing tablets with high hardness even at low compression forces — a property called "tableting ability" or "consolidation". MCC's compressibility index (Carr's Index) is typically 18–25%, indicating good-to-excellent flow.

Disintegration Mechanism

MCC acts as a disintegrant through the wicking (capillary absorption) mechanism. Water enters the tablet matrix via MCC's highly porous capillary structure, rapidly weakening inter-particulate bonds and causing disintegration. MCC-based tablets typically disintegrate in 2–15 minutes depending on formulation and compression force.

Flow Properties

MCC has moderate to good flow characteristics. Flow improves with increasing particle size (MCC 200 > MCC 102 > MCC 101). Silicified grades (MCC 301, 302) have the best flow — colloidal SiO₂ reduces inter-particle cohesion. Angle of repose: typically 35–45° for standard grades.

Self-Lubricating Property

Unlike many excipients, MCC has intrinsic lubricating properties due to its fibrous structure. MCC reduces tablet-punch adhesion (sticking/picking) and die-wall friction, enabling use of less magnesium stearate. Over-mixing with lubricants is less detrimental with MCC-based formulations.

Moisture Sorption

Standard MCC grades (101, 102, 200) absorb atmospheric moisture to NMT 5.0% w/w. This moisture acts as an internal plasticiser, improving compressibility but potentially affecting moisture-sensitive APIs. MCC 112 is engineered with low moisture ≤1.5% for hygroscopic drug formulations.

Chemical Inertness

MCC is chemically inert toward the vast majority of pharmaceutical APIs, excipients, food ingredients, and cosmetic actives. Its β-1,4-glucosidic bonds are not cleaved by mammalian digestive enzymes, making MCC non-digestible and physiologically inert — adding no caloric value to foods or supplements.

Compressibility Profile of AMBICEL MCC Grades

Grade Carr's Index (%) Hausner Ratio Angle of Repose (°) Compressibility Rating
MCC 10118–251.22–1.3435–42Excellent
MCC 10215–221.18–1.2833–40Excellent
MCC 11218–261.22–1.3535–43Excellent
MCC 20012–201.14–1.2528–36Superior flow + compressibility
MCC 301 (SMCC)10–181.11–1.2225–33Best flow of fine grades
MCC 302 (SMCC)8–151.09–1.1822–30Superior — best overall

AMBICEL MCC — Standard Quality Specifications

All AMBICEL MCC grades are tested against USP/NF, Ph.Eur, BP and JP pharmacopoeial monographs. Full Certificate of Analysis (CoA), Technical Data Sheet (TDS), and Material Safety Data Sheet (MSDS/SDS) are provided with each batch.

ParameterMCC 101MCC 102MCC 112MCC 200MCC 301MCC 302
AppearanceWhite to off-white, fine crystalline powder
IdentificationPasses USP/NF IR and colour tests
Particle size (µm)~50~100~50~180~50~100
Bulk density (g/mL)0.28–0.330.28–0.330.28–0.340.29–0.360.28–0.340.28–0.34
Loss on Drying (NMT%)5.05.01.55.05.05.0
pH (2% slurry)5.0–7.5
Residue on ignition (NMT%)0.1
Heavy metals (NMT ppm)10
Water-soluble substances (NMT%)0.25
Microbial limit (TAMC, NMT CFU/g)1000
Yeast & Mould (NMT CFU/g)100
E. coli / SalmonellaAbsent
SiO₂ contentNilNilNilNil~2%~2%

Packaging

  • Standard: 25 kg multi-layer paper bags with PE inner liner
  • Jumbo bags (500 kg / 1000 kg) available on request
  • Drum packing (20 kg HDPE drums) available
  • Sample quantities: 100 g, 500 g, 1 kg for evaluation
  • Export packing: palletised on heat-treated wooden pallets (ISPM-15)
  • Container loading: 20 FCL (~20–25 MT), 40 FCL (~40–50 MT)

Pharmacopoeial Compliance

AMBICEL MCC is manufactured and tested against the specifications of all major pharmacopoeias. This multi-pharmacopoeial compliance ensures regulatory acceptance in all major drug-approving markets globally.

USP/NF (United States)

United States Pharmacopeia — National Formulary monograph: "Microcrystalline Cellulose". The reference standard for pharmaceutical excipients in the US market. AMBICEL MCC meets all USP/NF identification, purity, and physical tests.

Ph.Eur (European Pharmacopoeia)

European Pharmacopoeia monograph: "Cellulosum microcristallinum". Mandatory compliance for pharmaceutical products sold across EU member states. AMBICEL MCC tested per Ph.Eur current edition specifications.

BP (British Pharmacopoeia)

British Pharmacopoeia monograph: "Microcrystalline Cellulose". Required for pharmaceutical products in the UK and Commonwealth markets. Maple Biotech supplies UK-specific CoA on request.

JP (Japanese Pharmacopoeia)

Japanese Pharmacopoeia: "結晶セルロース (Crystalline Cellulose)". Compliance with JP specifications required for pharmaceutical products in Japan. AMBICEL MCC JP-compliant grades available.

IP (Indian Pharmacopoeia)

Indian Pharmacopoeia monograph compliance. All AMBICEL MCC grades are manufactured in compliance with IP specifications, with testing conducted at our in-house WHO-GMP quality laboratory.

US-DMF Available

Drug Master File (DMF) submitted to the US FDA for AMBICEL MCC. Customers can reference Maple Biotech's DMF in their ANDA/NDA submissions, streamlining the regulatory approval process for the US market.

Certifications & Quality Standards

Maple Biotech's manufacturing facility operates under a comprehensive quality management system covering pharmaceutical GMP, food safety, environmental management, and occupational health — providing customers with the highest assurance of product consistency and regulatory compliance.

WHO-GMP
ISO 9001:2015
ISO 14001:2015
ISO 22000:2018
ISO 45001:2018
FSSC 22000
HALAL Certified
KOSHER Certified
FDA Maharashtra
FSSAI Approved
US-DMF Filed
Export Licence

Documents Available

  • Certificate of Analysis (CoA) — per batch
  • Technical Data Sheet (TDS)
  • Safety Data Sheet (SDS/MSDS)
  • Certificate of Origin (CoO)
  • Manufacturer's Declaration
  • Drug Master File (US-DMF) reference letter
  • HALAL / KOSHER certificates
  • BSE/TSE statement
  • GMO-free declaration
  • Allergen declaration

Testing Capabilities

  • Particle size analysis (laser diffraction)
  • Bulk / tapped density (USP apparatus)
  • Loss on drying (Karl Fischer / gravimetric)
  • pH measurement
  • Residue on ignition
  • Heavy metals (ICP-MS)
  • Microbial limits testing
  • HPLC purity testing
  • IR spectroscopy identification
  • Compressibility index (Carr's Index)

Supply Chain Integrity

  • Full traceability — raw material to finished product
  • Batch retention samples (minimum 3 years)
  • Stability testing (ICH conditions)
  • Change control and deviation management
  • Supplier qualification for raw materials
  • Annual product quality reviews (APQR)
  • Customer audit support

Global Supply of AMBICEL MCC

Maple Biotech exports AMBICEL MCC to pharmaceutical manufacturers, nutraceutical companies, food producers, and cosmetic manufacturers across 50+ countries. Our experienced export team manages international shipments with full documentation support for customs, regulatory filings, and import compliance.

Asia Pacific

  • India (domestic + pharmaceutical hubs)
  • Bangladesh, Sri Lanka, Nepal, Pakistan
  • Vietnam, Thailand, Indonesia, Philippines
  • Malaysia, Singapore, Myanmar
  • China, South Korea, Japan, Taiwan
  • Australia, New Zealand

Europe

  • Germany, France, UK, Italy, Spain
  • Netherlands, Belgium, Switzerland
  • Poland, Czech Republic, Hungary
  • Turkey, Russia, Ukraine
  • Nordic countries (Sweden, Norway, Denmark)
  • Eastern Europe distributors

Middle East & Africa

  • UAE, Saudi Arabia, Qatar, Kuwait
  • Oman, Bahrain, Jordan, Egypt
  • South Africa, Kenya, Nigeria, Ghana
  • Ethiopia, Tanzania, Morocco, Algeria
  • Israel, Iran, Iraq
  • Sudan, Zambia, Zimbabwe

Americas

  • USA — FDA DUNS-registered supplier
  • Canada, Mexico
  • Brazil, Colombia, Argentina
  • Chile, Peru, Ecuador
  • Venezuela, Dominican Republic
  • Central America (Guatemala, Costa Rica)

Export Documentation Provided

  • Commercial Invoice & Packing List
  • Certificate of Origin (CoO)
  • Analysis Certificate (CoA) per batch
  • Phytosanitary Certificate (where required)
  • Health Certificate / Free Sale Certificate
  • BSE/TSE Freedom Statement
  • Non-irradiation Declaration
  • Bill of Lading / Air Waybill support
  • US-DMF Reference Letter
  • HALAL / KOSHER Certificates

MCC — Technical FAQ

Answers to the most common questions from pharmaceutical formulators, food technologists, procurement managers, and regulatory affairs professionals about Microcrystalline Cellulose.

What is Microcrystalline Cellulose (MCC)?
Microcrystalline Cellulose (MCC) is a purified, partially depolymerised cellulose derived from high-quality wood pulp or cotton linters. It is a white, odourless, free-flowing powder widely used as a pharmaceutical excipient, food additive (E460i), and cosmetic ingredient. In tablets, MCC acts simultaneously as binder, diluent, disintegrant, and lubricant. It is compliant with USP/NF, Ph.Eur, BP, and JP pharmacopoeial monographs.
What is the difference between MCC 101 and MCC 102?
MCC 101 has a median particle size of ~50 µm, making it ideal for wet granulation and capsule filling. MCC 102 has a larger particle size of ~100 µm, giving it superior flowability and making it the preferred grade for direct compression (DC) tablet manufacturing. Both meet USP/NF, Ph.Eur, BP and JP specifications.
When should I use MCC 112 instead of MCC 101?
Use MCC 112 when formulating with moisture-sensitive APIs. MCC 112 has a Loss on Drying specification of NMT 1.5% (vs 5.0% for standard grades). This makes MCC 112 essential for aspirin (acetylsalicylic acid) tablets, effervescent tablet formulations, hygroscopic drug substances, and any API that hydrolyses or degrades in the presence of water.
What is silicified MCC (SMCC) and when should it be used?
Silicified MCC (SMCC), marketed as AMBICEL MCC 301 and 302, is MCC co-processed with 2% colloidal silicon dioxide (SiO₂). The silicification provides: dramatically improved powder flowability (Carr's Index ~10–18 vs 18–25 for standard grades), better compressibility at lower punch forces (protecting tooling), improved content uniformity for low-dose APIs, and enhanced resistance to over-lubrication with magnesium stearate. Use SMCC for challenging APIs with poor flow, high-speed tableting, and potent low-dose drugs requiring tight content uniformity.
Is MCC safe for human consumption?
Yes. MCC is physiologically inert and non-digestible — human digestive enzymes cannot break its β-1,4-glucosidic bonds. It passes through the GI tract unchanged and adds no caloric value. MCC is GRAS (Generally Recognized As Safe) by the US FDA, approved as food additive E460(i) in the EU (with quantum satis usage levels in most food categories), and is monographed in all major pharmacopoeias as an excipient safe for oral administration.
What typical concentration of MCC is used in tablet formulations?
MCC usage concentration varies by application: In direct compression tablets, MCC typically comprises 20–90% of the tablet weight. For wet granulation, intragranular MCC is typically 5–30% with optional extragranular addition of 5–15%. In capsule formulations, MCC 101 is used at 5–40% as diluent and lubricant. For extrusion-spheronisation pellets, MCC is used at 40–80% as the spheronising aid. These are typical ranges — optimal concentration is determined through formulation development trials.
What is the E number for MCC in food?
MCC is designated E460(i) — Microcrystalline Cellulose — in the European Union food additive numbering system. The related product Powdered Cellulose is E460(ii). The Codex Alimentarius designation is INS 460(i). In the USA, MCC is listed under 21 CFR 182.90 as GRAS. E460(i) is permitted quantum satis in most EU food categories with no stated maximum level, subject to good manufacturing practice (GMP).
How does MCC compare to lactose as a tablet diluent?
MCC and lactose are both widely used tablet diluents but differ significantly. MCC advantages over lactose: MCC is lactose-free (suitable for lactose-intolerant patients and vegans), MCC provides better disintegration (wicking vs swelling), MCC has better self-lubricating properties, and MCC is compatible with amine-containing APIs (which may cause Maillard browning with lactose). Lactose advantages: lower cost, better flow in some formulations, better taste for chewables. Many formulations use a combination of both excipients to optimise all tablet properties simultaneously.
Is AMBICEL MCC vegan and allergen-free?
Yes. AMBICEL MCC is derived from wood pulp (plant-based), making it 100% vegan. It contains no animal-derived ingredients, is GMO-free, allergen-free, and gluten-free. It carries HALAL and KOSHER certifications. Full declaration certificates are available on request.
What is the shelf life of AMBICEL MCC?
AMBICEL MCC has a shelf life of 3 years from the date of manufacture when stored under recommended conditions: temperature 15–30°C, relative humidity below 65%, away from moisture and direct sunlight. MCC is supplied in sealed 25 kg multi-layer paper bags with polyethylene inner lining. Once a bag is opened, it should be resealed promptly and used within a reasonable time period.
Can Maple Biotech provide samples of AMBICEL MCC?
Yes. Free evaluation samples of AMBICEL MCC (100 g to 500 g) are available for all six grades (101, 102, 112, 200, 301, 302). Samples are dispatched with a Certificate of Analysis, Technical Data Sheet, and Safety Data Sheet. Contact Maple Biotech at sales@maplebiotech.co.in or +91 86699 59208 to request samples.
What are the lead times and minimum order quantities?
Minimum order quantity: 25 kg (one bag). Standard lead time for stocked grades (MCC 101, 102): 7–14 working days from order confirmation. For less common grades (MCC 112, 200, 301, 302): 14–21 working days. Export orders to international destinations: add 7–14 days for shipping transit. For emergency requirements, expedited dispatch is available — contact our sales team.

Request AMBICEL MCC Samples & Quotation

Get free evaluation samples, technical data sheets, and competitive pricing for AMBICEL MCC grades 101, 102, 112, 200, 301, and 302. Our technical team is ready to assist with grade selection and formulation support.

sales@maplebiotech.co.in  ·  +91 86699 59208  ·  Exporting to 50+ countries