MCC Grades Quick Guide: PH101, PH102, PH200

Microcrystalline cellulose (MCC) is a cornerstone tablet excipient used across pharmaceutical and nutraceutical manufacturing as a binder, filler and functional disintegrant. The right grade choice hinges on particle-size distribution (PSD), bulk/tapped density, and how each grade balances flow versus compressibility on your press. This quick guide gives formulation, QA/QC and sourcing teams a practical map to select PH101, PH102, or PH200, specify batch-by-batch CoA data, and qualify suppliers with confidence.

1 — Choosing the right MCC grade (PH101 | PH102 | PH200)

When picking a grade, start from your performance target (weight uniformity, hardness, friability, disintegration) and your line constraints (direct compression vs. wet granulation; press speed; feeder behavior). Then confirm functional fit with PSD and density data on the batch CoA.

Note: Actual d10/d50/d90 and bulk/tapped densities vary by manufacturer. Always require batch-specific PSD and density on the CoA; verify performance with your blend and press settings.

2 — QC and pharmacopoeia checklist (what your CoA must include)

Procurement should be CoA-driven. Request a complete, per-batch CoA with validated methods and acceptance criteria. Minimum fields to require:

• Pharmacopoeial identity (USP/NF, Ph. Eur., JP) with method reference
• Particle-size distribution: d10 / d50 / d90 (µm)
• Loss on drying (%) and/or water activity (aw)
• Bulk and tapped density (g/mL)
• Residue on ignition / sulfated ash (%)
• Elemental impurities (Pb/As/Cd/Hg, ppm)
• Microbial limits: TPC, yeast, mold, coliforms (CFU/g)
• pH (where applicable), morphology notes or SEM (if required)
• Shelf life, storage conditions, packaging details (bag, PE liner, net weight)
• Nitrite/nitrosamine screening if your API/coating system poses nitrosation risk
• Full traceability: lot number, manufacture date, COA issue date, QC signatory
• Retention sample policy and right to third‑party testing

Printable one‑page CoA request

ONE‑PAGE MCC CoA CHECKLIST (request per batch)
- Supplier name / lot #: ____________________
- Pharmacopoeia reference: USP / Ph.Eur. / JP (circle)
- Identity test & method: ___________________
- PSD: d10 / d50 / d90 (µm)
- Loss on drying (%) / moisture / water activity (aw)
- Bulk density / Tapped density (g/mL)
- Residue on ignition / sulfated ash (%)
- Elemental impurities: Pb / As / Cd / Hg (ppm)
- Microbial limits: TPC / Yeast / Mold / Coliforms (CFU/g)
- pH
- Nitrite / nitrosamine tests (if applicable)
- Particle shape / SEM (if required)
- Packaging (bag, liner, net wt) & storage advice
- Shelf life / manufacture date / expiry
- Retention sample policy & location
- COA issue date & QC signatory
- Right to third‑party testing: YES / NO

3 — RFQ language you can copy/paste

Lock in CoA deliverables and regulatory support in your RFQ. This prevents surprises when you file or scale.

RFQ: Supply MCC PH‑101, USP/NF grade. Attach batch CoA showing identity per USP, PSD (d10/d50/d90), LOD, bulk/tapped density, elemental impurities, microbial limits. Provide GMP evidence and DMF/CEP reference. Packaging: 25 kg kraft bag with PE liner. Lead time: ____ weeks. Retention sample: ≥500 g per lot. Right to third‑party test: reserved.
SLA (5 points): on‑time ≥95%; COA accuracy ≥99%; deviation response ≤48h; full traceability; corrective action plan.

4 — Seven‑step supplier qualification scorecard

Score candidates against these universal criteria before you run trials:

1. GMP evidence: certificates and quality system documents (IPEC/ISO policies)  
2. Regulatory support: DMF/CEP availability or letter of access  
3. Batch consistency: 3 recent CoAs for trend review (PSD, density, LOD)  
4. Retention samples: policy, storage conditions and duration  
5. Audit and test rights: on‑site audit acceptance; third‑party testing rights  
6. Capacity and continuity: lead times, contingency stock, scale‑up pathway  
7. Technical support: compaction/moisture sorption data; application help for DC and wet granulation

Tip: Shine Health operates GMP-standard workshops and supports excipient programs globally. See microcrystalline cellulose category at www.sdshinehealth.com/microcrystalline/.

5 — Practical pairing and real‑world examples

• Weight variation on a 300 mg DC tablet: switching PH101 → PH200 improved bulk density and hopper flow, reducing feeder starvation and tightening RSD.  
• Supplement mouthfeel and stability: MCC pairs well with soluble fibers for texture and process flexibility; evaluate moisture sorption and compaction early.

Shine Health can supply MCC alongside soluble fibers for trials:

• MCC products: https://www.sdshinehealth.com/microcrystalline/
• Resistant dextrin options: https://www.sdshinehealth.com/resistant-dextrin/

6 — Fast path to qualification and scale‑up

• Map tablet targets (hardness, disintegration, friability, weight RSD) to a preferred MCC grade  
• Request batch CoAs for two recent lots with PSD and density  
• Run benchtop tests for flow (angle of repose, Hausner/Carr’s index) and compressibility (tensile strength vs. pressure) on your blend  
• Compare press performance at line‑representative speeds; finalize your specification window  
• Complete a supplier scorecard; secure samples and technical support for submission work

For batch CoAs or samples, contact Shine Health: info@sdshinehealth.com or WhatsApp +86‑134‑0544‑3339.

References

• Chaerunisa, A. Y., Sriwidodo, & Abdassah, M. (2019). Microcrystalline cellulose as pharmaceutical excipient. In Pharmaceutical Formulation Design – Recent Practices. IntechOpen. https://doi.org/10.5772/intechopen.88092
• Baserinia, R. (2017). Flow of fine and cohesive powders under controlled air pressure conditions (Doctoral dissertation). https://www.semanticscholar.org/paper/0dcb26f5dc7c35e6600bbb626f6e2732a085c9b9
• Queiroz, A. L. P., Kerins, B. M., Yadav, J., et al. (2021). Investigating microcrystalline cellulose crystallinity using Raman spectroscopy. Cellulose, 28, 10011–10028. https://doi.org/10.1007/s10570-021-04093-1
• Sperger, D. M., & Munson, E. J. (2011). Analysis of structural variability in pharmaceutical excipients using solid-state NMR spectroscopy. AAPS PharmSciTech, 12(2), 673–684. https://doi.org/10.1208/s12249-011-9637-7
• Haruna, F., Apeji, Y. E., & Oyi, A. R. (2022). Development and characterization of a microcrystalline cellulose-based co-processed excipient using a design of experiment approach. Jordan Journal of Pharmaceutical Sciences, 15(4), 453–469. https://doi.org/10.35516/jjps.v15i4.678
• Rojas, J., López, A., Gamboa, Y., González, C., & Montoya, F. (2011). Assessment of processing and polymorphic form effect on the powder and tableting properties of microcrystalline celluloses I and II. Chemical & Pharmaceutical Bulletin, 59(5), 603–611. https://doi.org/10.1248/cpb.59.603
• Liew, C. V., Soh, J. L. P., Chen, F., Shi, D., & Heng, P. W. S. (2005). Application of multidimensional scaling to preformulation sciences: A discriminatory tool to group microcrystalline celluloses. Chemical & Pharmaceutical Bulletin, 53(10), 1227–1231. https://doi.org/10.1248/cpb.53.1227