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Microcrystalline Cellulose Specification and CoA: MCC Buyer Checklist
Microcrystalline cellulose specification and CoA checklist: documents, key parameters and USP/EP/BP checks for buying MCC 101 and MCC 102.
Microcrystalline cellulose (MCC) is one of the most widely used excipients in tablets and capsules. Because it often makes up a large share of a formulation, the microcrystalline cellulose specification and the certificate of analysis (CoA) deserve a careful look before every new supplier approval or batch release. This checklist explains which documents and parameters buyers, QA teams and formulators should review when sourcing MCC 101 and MCC 102.
Why the Microcrystalline Cellulose Specification Matters
MCC is used as a filler, binder and disintegration aid, especially in direct compression and wet granulation. Small differences in particle size, moisture or bulk density can change how a blend flows, how tablets compress and how consistent tablet weight is on the press.
A clear specification protects both sides of the supply chain. It defines what the material must meet, it makes incoming inspection faster, and it reduces the risk of surprises during scale-up or regulatory audits.
Documents to Request Before Approval
Before the first order, most pharma and food manufacturers ask for a standard document package. For microcrystalline cellulose, this typically includes:
- Product specification – the agreed limits for each test parameter and the grade (for example MCC 101 or MCC 102).
- Certificate of analysis (CoA) – batch-specific results compared with the specification.
- Safety data sheet (SDS) – handling, storage and transport information.
- Pharmacopoeia compliance statement – confirmation of conformity with USP, EP and/or BP monographs.
- Quality management information – for example, information on ISO 9001 certified production.
- Shelf life and storage statement – including recommended storage conditions.
MCC CoA Checklist: Key Parameters
A CoA is only useful if you know what to compare. The table below lists parameters commonly found on an MCC CoA and why each one matters in production.
| Parameter | Why it matters |
|---|---|
| Identification | Confirms the material is microcrystalline cellulose. |
| Particle size distribution | Influences flow, blend uniformity and the difference between grades. |
| Bulk density | Affects die filling, hopper behaviour and tablet weight. |
| Loss on drying | Moisture influences compressibility and stability of moisture-sensitive actives. |
| pH and conductivity | Indicate purity and residual soluble substances. |
| Water- and ether-soluble substances | Pharmacopoeial purity tests for soluble impurities. |
| Sulfated ash | Indicates inorganic residues. |
| Microbiological limits | Essential for pharma, food supplements and food applications. |
Always compare the CoA against the agreed specification and the current pharmacopoeia edition your product dossier refers to.
MCC 101 vs. MCC 102 on the CoA
Both grades are chemically the same material. The main differences you will see on the CoA are particle size and bulk density. MCC 101 is the finer grade and is often used in wet granulation, while MCC 102 has a coarser particle size with better flow for direct compression. Our detailed grade comparison is available in the article MCC 101 vs. MCC 102.
Pharmacopoeia Grades: USP, EP and BP
Microcrystalline cellulose for pharmaceutical use is described in the major pharmacopoeias. If you sell in several markets, check that the material is tested against all monographs that apply to your products. A grade that complies with USP, EP and BP gives you more flexibility when one formulation is used for different regions.
The European Pharmacopoeia also lists functionality-related characteristics for MCC, such as particle size distribution and powder flow. These are not mandatory limits, but they are useful for agreeing on grade-specific values with your supplier.
Handling and Storage Checklist
- Store bags closed, in a dry and clean area, away from strong odours.
- Protect the material from humidity, as MCC can take up moisture.
- Use the first-in, first-out principle and track the shelf life of each batch.
- Check bag integrity and labels during incoming inspection.
- Keep the CoA linked to the batch number in your ERP or quality system.
Frequently Asked Questions
What is the CAS number of microcrystalline cellulose?
The CAS number of microcrystalline cellulose is 9004-34-6, and the EINECS number is 232-674-9.
Which MCC grade should I choose?
It depends on your process. MCC 101 is a common choice for wet granulation, and MCC 102 is often preferred for direct compression thanks to its better flow. Many formulators test both grades during development.
Can I get a sample and the specification before ordering?
Yes. Specification, CoA, SDS and samples are available on request, so your QA and R&D teams can evaluate the material before the first order.
Microcrystalline Cellulose from biolla chemicals
biolla chemicals supplies MCC 101 and MCC 102 (CAS 9004-34-6, EINECS 232-674-9) in USP/EP/BP quality from ISO 9001 certified production. The material is packed in 20 kg bags and has a shelf life of 24 months. We deliver across Europe from our location in Hamburg.
Learn more on our product page for microcrystalline cellulose.
Request a specification, CoA, SDS or sample:
- Contact form
- Email: info@biolla.de
- Phone: +49 40 67 555 155
