| HS Code | 850456 |
| Chemicalname | Cellulose |
| Casnumber | 9004-34-6 |
| Molecularformula | (C6H10O5)n |
| Molecularweight | Variable polymer; constitutional unit 162.14 g/mol |
| Appearance | White or almost white, free-flowing powder |
| Odour | Odourless |
| Taste | Tasteless |
| Solubility | Practically insoluble in water and most organic solvents; slightly soluble in sodium hydroxide solution |
| Bulkdensity | Typically 0.20-0.50 g/mL |
| Tappeddensity | Typically 0.30-0.60 g/mL |
| Particlesize | Pharmaceutical grades commonly 20-200 µm, depending on grade |
| Ph | 5.0-7.5 in aqueous dispersion |
As an accredited Cellulose Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Packaged in sealed, moisture-resistant 25 kg drums with tamper-evident liners, ensuring purity and stability for oral and injectable pharmaceutical formulations. |
| Container Loading (20′ FCL) | 20′ FCL: Pharma-grade cellulose API loaded palletized, secured in clean dry container, protected from moisture/contamination for oral/injectable forms. |
| Shipping | All shipments of Cellulose Pharma Grade API are packed in sealed, moisture-resistant containers with tamper-evident labeling. Transport follows GMP and international pharmaceutical regulations, ensuring temperature-controlled, protected delivery worldwide. Documentation includes Certificate of Analysis and Material Safety Data Sheet for safe handling and regulatory compliance. |
| Storage | Store in a tightly sealed, food-grade container, protected from moisture, heat, and direct sunlight. Keep in a cool, dry, well-ventilated area at controlled room temperature (15–25°C). Avoid exposure to excessive humidity, which may affect flow and compressibility. Ensure containers remain closed when not in use and follow first-expiry-first-out rotation. For injectable grades, maintain strict protection from contamination. |
| Shelf Life | Shelf Life: 36 months from manufacture date when stored in original tightly closed container below 25°C, protected from moisture. |
Microcrystalline cellulose at a nominal mean particle size of 100 µm and moisture content not more than 5.0% according to USP/NF Loss on Drying is blended at 20% w/w to 60% w/w of the final tablet mass, depending on API dose and powder flow. In rotary tablet presses operating at 30–80 rpm and main compression force between 10 kN and 25 kN, the excipient undergoes plastic deformation; brittle fragmentation is limited because the material retains a low elastic recovery of approximately 8–12% after decompression, which prevents capping. Direct compression blends must meet USP <1174> powder flow criteria; a typical formulation adjusts flow with 0.5–1.5% w/w colloidal silicon dioxide, but this is premixed with cellulose through a 500 µm screen to avoid segregation. Lubrication with magnesium stearate at 0.5–1.0% w/w is added last and limited to 3–5 min blending because extended shear coats the cellulose fibers, increases hydrophobicity, and retards disintegration. Tablet hardness of 80–150 N is achievable at 100–200 MPa compaction pressure; higher compression force above 300 MPa may cause plastic flow into die-wall pores, elevate ejection force, and trigger variable weight due to punch sticking on prolonged campaigns. Finished tablets are tested for disintegration time according to USP <701>, with uncoated direct compression tablets typically disintegrating within 5–10 min in water at 37°C, and dissolution is assessed by USP <711> Apparatus 2 at 50 rpm with phosphate buffer pH 6.8.
In capsule manufacture, a low-moisture cellulose diluent is matched to the dosing chamber geometry of the capsule filler. On a GKF 2600 or similar tamping-pin machine, a medium-particle-size grade with tapped density 0.35–0.42 g/cm³ and Carr index 20–25% is preferred because it compresses under the tamping pins into a stable plug. The plug must remain intact during transfer into size 0 or size 00 hard gelatin capsules; plug height is set between 8 mm and 14 mm, depending on nominal fill weight. If the cellulose contains residual moisture above 3.0%, the material may adhere to the tamping pins and cause weight variation exceeding the USP <905> acceptance value. The corrective approach is to pre-blend the cellulose with 0.2–0.5% w/w fumed silica and pass the mixture through a 425 µm screen; this reduces triboelectric charge and lowers relative humidity sensitivity during filling. Capsule content uniformity for low-dose APIs is improved by keeping the API particle size distribution D90 below 30 µm, while the cellulose carrier is coarser, with D50 near 100 µm, to reduce segregation by percolation during hopper discharge. Dissolution testing follows USP <711> with Apparatus 1 or 2, and the capsule shell is qualified for moisture transfer; storing the filled product at 40°C/75% RH for 6 months per ICH Q1A stability protocol is typical for zone IVb batches.
Dry granulation with microcrystalline cellulose as a dry binder is carried out on a roller compactor with smooth or knurled rolls, roll pressure from 20 kN to 80 kN, roll speed 2–12 rpm, and gap setting 1.5–3.0 mm. The cellulose loading is typically 10–40% w/w; below 10% w/w, the ribbon may be too weak and shatters into fines, while above 40% w/w, the ribbed surface can overcompress and produce a ribbon density above 1.2 g/cm³, which reduces granule porosity and tablet disintegration. Ribbon density is monitored in-process within 0.9–1.15 g/cm³ using a Heckel plot or online density measurement; a target solid fraction of 0.55–0.70 balances granule strength and compressibility. After compaction, the ribbons are milled through a conical mill with a 0.8–1.25 mm screen at 1000–1500 rpm; the resulting granules show a bimodal size distribution, with 15–30% fines below 75 µm required to fill intragranular voids during final compression. The key limitation is work hardening; because microcrystalline cellulose undergoes plastic deformation in the first compression, recompression of granules requires an additional 10–20% compaction force to reach the same tablet hardness, and the final tablet often shows lower friability if the granule solid fraction is kept below 0.65. In a formulation containing a moisture-sensitive API such as acetylsalicylic acid, dry granulation avoids hydrolysis caused by aqueous binder solution; the cellulose must still be dried to a loss on drying below 2.5% and stored at RH below 40% to prevent sticking to the rolls. Final tablets are assessed by USP <1216> tablet friability and USP <701> disintegration; a dry-granulated tablet with 20% w/w MCC and 1% w/w magnesium stearate typically has friability below 0.8% after 100 rotations.
In high-shear wet granulation, cellulose as the filler-binder is added at 30–50% w/w of the dry powder mass, usually after pre-blending with the API and a disintegrant such as croscarmellose sodium at 2–5% w/w. Granulation is performed in a top-driven high-shear mixer with impeller speed 300–500 rpm and chopper speed 1500–3000 rpm; purified water is sprayed at 5–10% w/w of the dry mass, but the exact endpoint is determined by impeller torque and not by a fixed water volume, because microcrystalline cellulose retains water in its porous structure. Overwetting above 18–20% w/w water produces a paste that blocks the mill; under-wetting below 5% w/w generates friable granules with 30% or more fines. The wet mass is passed through a 1.0–2.0 mm screen and dried in a fluid-bed dryer at inlet air temperature 60–70°C until loss on drying is 2.0–3.5%; higher inlet temperature above 80°C can form a hard surface crust on the granules and produce a two-population moisture profile. The dried granules are milled again through a 1.0 mm screen and lubricated in a bin blender for 3 min with 0.5% w/w magnesium stearate. The granules are used for tablet compression or filled into sachets as oral granules; bulk density after milling should be 0.35–0.45 g/cm³ and the fine fraction below 75 µm controlled at 20–35% to ensure content uniformity under USP <905>. Dissolution of the granules, if formulated as a modified-release oral product, is evaluated by USP <711> using Apparatus 2 with pH change media; for immediate-release granules, disintegration in 0.1 N HCl at 37°C should occur within 15 min.
| Process | Typical cellulose loading | Critical control window | Test method / equipment |
|---|---|---|---|
| Direct compression tablet | 20–60% w/w | Main compression 10–25 kN; ejection <15 kN | USP <1174>; rotary press |
| Capsule plug filling | 30–80% w/w | Tapped density 0.35–0.42 g/cm³; Carr index 20–25% | USP <616>; GKF tamping pin |
| Roller compaction | 10–40% w/w | Ribbon solid fraction 0.55–0.70; density 0.9–1.15 g/cm³ | Heckel plot; conical mill |
| Wet granulation | 30–50% w/w | Water 5–20% w/w; drying inlet 60–70°C | USP <701>; fluid-bed dryer |
For oral suspension compounding, a co-processed microcrystalline cellulose and sodium carboxymethylcellulose carrier requires high-shear dispersion followed by controlled hydration; the cellulose network forms a thixotropic gel with apparent viscosity in the range of 800–3000 mPa·s at 25°C when measured by a rotational viscometer at 20 rpm using spindle LV-4. The suspending agent is first dispersed in water at 20–30°C using a high-shear mixer at 1000–3000 rpm for 10–15 min; hydration is then completed under low shear for 60–120 min to avoid air entrapment. For an oral suspension of a low-solubility API, the typical concentration of the co-processed cellulose is 0.8–2.0% w/w, with additional microcrystalline cellulose at 0.5–1.0% w/w to modify sedimentation volume. The finished suspension is preserved with methylparaben at 0.1% and propylparaben at 0.02%; the pH is buffered to 4.0–6.0 with citrate buffer to avoid acid hydrolysis of the cellulose backbone. Sedimentation volume after 24 h should remain above 0.90, and redispersibility is checked by manual inversion—not by high-shear mixing—because excessive energy irreversibly breaks the gel network. The product is qualified for microbial quality under USP <1111> and for preservative efficacy under USP <51>; viscosity is released against a specification of 1500–2500 mPa·s at 25°C. Oral suspensions are not subject to sterility requirements, but the cellulose component must comply with the microbial limits of USP/NF and Ph. Eur. 5.1.4 for non-sterile products.
When the route of administration changes from oral to parenteral, cellulose particle size and endotoxin load become the primary process constraints. Injectable dose forms containing cellulose require a deliberately narrow particle size distribution, because the compendial limit for particulate matter in injections, USP <788>, rejects large particles regardless of origin. For a cellulose-based suspending agent intended for an aqueous injectable suspension, the mean particle size is typically below 5 µm, and the absence of particles above 25 µm is verified by light obscuration particle count testing according to USP <788> Method 1; if the formulation is a suspension rather than a solution, Method 2 microscopic particle count may be applied with justified limits. The route requires endotoxin control below 0.5 EU/mL for large-volume parenterals or below 5 EU/kg body weight per hour for small-volume parenterals, tested by USP <85>; depyrogenation of the cellulose component is achieved by dry heat at 250°C for a minimum of 30 min, though published data for stability of microcrystalline cellulose after this depyrogenation cycle is limited. The sterile suspension is prepared by terminal sterilization if viscosity and particle settling permit; autoclaving at 121°C for 15 min is preferred over filtration because aqueous cellulose suspensions block sterilizing-grade 0.22 µm membranes. If filtration is unavoidable, a prefilter of 0.45 µm followed by a sterilizing filter is used, but the cellulose concentration is kept below 0.1% w/w to avoid transmembrane pressure rise above 1.5 bar. In injectable formulation development, the osmolality is adjusted to 290–320 mOsm/kg with sodium chloride or mannitol, and the final product is tested for sterility according to USP <71> and for visible particles under USP <790>. The use of native microcrystalline cellulose without surface modification is not recommended for intravenous administration due to foreign-body retention and capillary occlusion risk; if the target is an intradermal or subcutaneous depot, each lot must be qualified for absence of β-glucan polymers by a Limulus amebocyte lysate reactive pathway with β-glucan blockers.
| Quality attribute | Limit | Method |
|---|---|---|
| Sub-visible particles ≥ 10 µm | ≤ 25/mL for large-volume parenterals | USP <788> Method 1 |
| Sub-visible particles ≥ 25 µm | ≤ 3/mL for large-volume parenterals | USP <788> Method 1 |
| Bacterial endotoxins | <0.5 EU/mL large volume; 5 EU/kg/h small volume | USP <85> |
| Sterility | No growth after 14 days | USP <71> |
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Cellulose Pharma Grade API for Tablet / Capsule / Granule / Injection, Oral & Injectable is supplied as a purified, water-insoluble, partially depolymerized cellulose material manufactured under active-ingredient quality systems. It conforms to USP–NF Microcrystalline Cellulose, Ph. Eur. 0316, and JP 1612; grade designations PH-101, PH-102, PH-105, PH-200, and low-moisture variants are controlled for particle size distribution, bulk density, loss on drying, residue on ignition, and microbial limits. In tablet, capsule, and granule processing the material functions as binder, diluent, disintegrant, and direct-compression matrix former. For injectable applications, only low-endotoxin and low-bioburden lots are eligible, and the material is used as a suspended solid or suspending agent rather than as a solution. The API designation refers to manufacture under active-ingredient quality systems, not to a direct pharmacological action.
| Grade designation | Typical median particle size | Bulk density | Loss on drying | Primary process fit |
|---|---|---|---|---|
| PH-101 | 50–80 µm | 0.26–0.31 g/cm³ | ≤7.0% w/w | Direct compression, capsule filler |
| PH-102 | 90–150 µm | 0.28–0.33 g/cm³ | ≤7.0% w/w | High-dose direct compression |
| PH-105 | 20–30 µm | 0.20–0.28 g/cm³ | ≤7.0% w/w | Low-dose blend uniformity, granulation |
| PH-200 | 150–220 µm | 0.33–0.40 g/cm³ | ≤7.0% w/w | Flow-critical capsule filling |
The tabulated values are typical manufacturer release ranges; compendial monographs do not fix every median particle size, so the selected grade must be confirmed against the technical file and the intended direct-compression or granulation process. Particle size distribution is determined by analytical sieving or laser diffraction according to USP <786> or Ph. Eur. 2.9.12. Oral-grade batches are tested by USP <61> and USP <62> for total aerobic microbial count ≤10³ CFU/g, total yeast and mold count ≤10² CFU/g, and absence of Escherichia coli and Salmonella species. Injectable-grade lots add bacterial endotoxin testing per USP <85> and particulate matter control after dispersion per USP <788>.
In direct compression, the material deforms plastically and is used at 20–90% w/w. Compaction simulator data report a mean yield pressure of 80–120 MPa, which is lower than the brittle fracture threshold of typical inorganic diluents. The plastic flow mechanism produces high tablet tensile strength but creates sensitivity to lubricant coating and strain rate. When magnesium stearate is blended for more than 5 min at 25 rpm in a bin blender, the hydrophobic film covers the cellulose particles and reduces interparticle hydrogen bonding; tablet breaking force declines by 10–30% relative to a 2 min mix at the same speed. Tablet breaking force is measured according to USP <1217>. The effect is more pronounced with fine PH-105 because the higher specific surface area requires more lubricant contact area and shows greater loss of tablet hardness at equivalent lubricant concentration.
Production rotary presses typically operate with pre-compression 2–5 kN and main compression 8–18 kN. Turret speed is maintained between 30 rpm and 60 rpm for direct-compression formulations; above 80 rpm the dwell time falls below 20 ms and the time-dependent plastic deformation may produce lower tensile strength. Ejection force increases when moisture content falls below 3.0% w/w, while moisture above 5.0% w/w raises capping risk and die-wall friction sensitivity. The material compacts well on rotary presses and compaction simulators, but scale-up must record pre-compression force, main compression force, and turret speed because the plastic deformation response is not linear with press speed.
Disintegration time for uncoated tablets is assessed by USP <701>. In direct-compression formulations containing sodium starch glycolate at 2–5% w/w, disintegration times below 15 min are commonly achieved. Crospovidone at 2–5% w/w can be added when faster aqueous penetration is required. The water-insoluble cellulose swells without dissolving, creating pores that break the tablet apart; this mechanism is less rapid than soluble diluent dissolution but provides robust tablet strength. Friability is controlled below 1.0% w/w after 100 revolutions per USP <1216>. Excessive lubricant mixing, low moisture, and high final compression force can shift the compact from plastic deformation toward elastic recovery, and this shift is usually detected by increased friability rather than by lower hardness alone.
At storage relative humidity above 60% RH, the material can absorb water and shift tablet hardness. Pre-drying is recommended at 50–60 °C for 2–4 h when moisture content exceeds 5.0% w/w. Moisture sorption is moderate below 30% RH and becomes more pronounced above 50% RH, so direct-compression blends should be processed under controlled humidity. In dry granulation by roller compaction, ribbon solid fraction is maintained between 0.50 and 0.65. Higher ribbon solid fraction reduces re-compaction tablet strength because the material loses part of its plastic deformation capacity after work hardening.
Cellulose API is incorporated intragranularly at 20–50% w/w in high-shear wet granulation. Granulation endpoint is controlled by impeller power consumption and granule moisture after fluid-bed drying to 1–3% w/w loss on drying per USP <731>. The product absorbs water and reduces overwetting risk, but the wet mass retains moisture; fluid-bed inlet air temperature should remain below 60 °C to avoid surface discoloration. Dried granules typically show Carr index 15–20% and Hausner ratio 1.15–1.25. An extragranular portion at 5–15% w/w may be added to preserve tablet disintegration when the intragranular fraction is high.
For capsule filling, PH-101 and PH-105 grades improve blend uniformity; however, flow-limited lots are roller compacted or wet granulated before encapsulation. On dosator-type encapsulators operating above 30,000 capsules/h, PH-102 or PH-200 may be required to keep fill weight variability below 3% RSD and to meet the uniformity-of-dosage-units acceptance criteria of USP <905>. Powder flow is measured by the Carr index or by shear cell methods; a compressibility index below 15% is generally preferred for high-speed filling, while values above 25% indicate poor flow and require granulation.
Injectable use imposes additional controls not applied to oral grades. The material is water-insoluble and does not form a molecular solution; therefore injectable application is as a suspended solid or in a co-processed suspending-agent system. Batches intended for injection are selected from low-endotoxin lots, with bacterial endotoxin tested by USP <85> or Ph. Eur. 2.6.14 and particulate matter tested by USP <788>. Endotoxin limits are derived from the intended maximum dose; a control point of ≤0.5 EU/mg is used in many dossiers, but the final limit must be justified from the dosing regimen. Published data for specific injectable formulations using unmodified microcrystalline cellulose is limited. Injectable products containing microcrystalline cellulose are often co-processed with carboxymethylcellulose sodium to obtain colloidal dispersibility and reduce sedimentation.
The native material is not sterile. Terminal sterilization by moist heat at 121 °C for 15 min must be validated because autoclaving can cause particle aggregation and shift particle size distribution in aqueous suspension. Aseptic processing may be required when moist-heat instability cannot be resolved by formulation adjustments. Sterility testing is performed per USP <71>; bacterial endotoxin and particulate matter are re-tested after terminal sterilization because the process can change surface charge and aggregation state. For injectable suspensions, the solid phase is normally reduced to a particle size below d90 < 10 µm to minimize the risk of exceeding the USP <788> particle count thresholds. Particle size is monitored by laser diffraction before and after high-shear dispersion.
The suspension is buffered to pH 4.0–8.0; outside this range acid hydrolysis or alkaline chain scission accelerates. Terminal sterilization of a low-pH suspension can further depolymerize cellulose, so pH and oxygen exposure during the autoclave cycle are controlled. Syringeability is measured by injection force through a 21 G needle under controlled rate, and the concentration is driven by the drug and the required suspension viscosity rather than by a fixed excipient level. Published data for this specific injectable configuration is limited, so formulation development must confirm syringeability, particle size stability, and sterility after the complete manufacturing route.
Against powdered cellulose, the defining difference is the removal of amorphous cellulose regions by acid hydrolysis during manufacture. Powdered cellulose retains a more fibrous alpha-cellulose structure and has lower compressibility, whereas the product's PH-102 and PH-200 grades deform plastically and produce stronger tablets at equivalent compression force. Compared with lactose monohydrate, the product does not participate in Maillard browning with amine-containing actives, and compared with dicalcium phosphate dihydrate, it does not generate acid effervescence. Its water-insoluble swelling mechanism, however, can prolong disintegration relative to highly soluble diluents, and it is hygroscopic; moisture uptake above 5.0% w/w modifies tablet hardness and flow.
| Attribute | Cellulose pharma grade API | Powdered cellulose | Lactose monohydrate | Dicalcium phosphate dihydrate |
|---|---|---|---|---|
| Dominant compaction mechanism | Plastic flow | Limited plastic flow, fibrous | Fragmentation | Brittle fracture |
| Typical direct-compression mass fraction | 20–90% w/w | 5–40% w/w | 40–90% w/w | 10–50% w/w |
| Disintegration tendency | Swelling, good | Poor unless disintegrant added | Dissolution, moderate | Insoluble, can prolong disintegration |
| Chemical incompatibility | Strong oxidizers, concentrated acids | Strong oxidizers, concentrated acids | Maillard with amines | Acid consumption |
| Moisture sensitivity | Hygroscopic; hardness changes above 5.0% w/w moisture | Higher residual water | Low hygroscopicity | Low hygroscopicity |
Table data derive from published excipient monographs and direct-compression studies; exact deformation properties vary with source and grade, and the selected supplier's technical file should be used for formulation limits. Compared with carboxymethylcellulose sodium, the product is water-insoluble and does not form a clear solution; the two materials are sometimes co-processed when colloidal dispersion or ionic suspending performance is required.
When dispersed in water, cellulose API forms a shear-thinning suspension. Rotational rheometry per ISO 3219 shows viscosity decreases with increasing shear rate; this behavior is used in oral suspensions and in some injectable suspension designs. Dispersion requires high-shear mixing. Low-shear paddle mixing leaves visible agglomerates, and the slurry may require homogenization at 5,000–15,000 rpm before final dilution.
The pH is maintained within 4.0–8.0 because acid hydrolysis accelerates below pH 4.0, while alkaline degradation occurs above pH 8.0. Preservative adsorption onto cellulose surfaces can reduce antimicrobial efficacy; therefore benzalkonium chloride systems require preservative efficacy testing per USP <51>. Avoid hypochlorite, peroxides, and strong acids due to oxidative chain scission. In autoclave cycles, post-sterilization particle size and viscosity must be re-tested per USP <788> and ISO 3219. For oral suspensions, the material can be used at 1.0–3.0% w/w with a suspending aid; for injectable suspensions the concentration is driven by the drug and the required syringeability, which is measured under controlled injection force.
