Microcrystalline Cellulose PH-102
City: LV, Marupe
Please avoid sudden changes in temperature and humidity, as they may affect the condition of derivative ingredients and tablets.
The shelf life begins from the date of manufacture at the factory.
Taking into account logistical and transportation stages, the remaining shelf life of the product is always shorter than the full shelf life.
We ship products to our customers with a remaining shelf life of no less than 70%.
Pharmacopoeial Test Items
Test Item | Specification | Result |
Identification A (Zinc Chloride test) | Corresponds to USP/NF, JP, Ph. Eur., BP | Passes |
Identification B (Degree of Polymerization) | NMT 350 as USP/NF, Ph.Eur., BP | Complies |
Solubility (coppertetramine solution) | Have to correspond Ph.Eur., BP | Complies |
pH | 5.0–7.5 as USP/NF, Ph.Eur., BP | 6.51 |
Conductivity | NMT 75 µS/cm as USP/NF, Ph.Eur., BP | 52 µS/cm |
Water-Soluble Substance | NMT 0.25% as USP/NF, Ph.Eur., BP | 0.1486% |
Ether-Soluble Substance | NMT 0.05% as USP/NF, Ph.Eur., BP | 0.0282% |
Loss on Drying | NMT 7.0% as USP/NF, Ph.Eur., BP | 3.501% |
Heavy Metals | NMT 10 ppm as USP/NF, Ph.Eur., BP | Complies |
Residue on Ignition / Sulphated Ash | NMT 0.1% as USP/NF, Ph.Eur., BP | 0.0315% |
Standards
Test Item | Specification | Result |
Bulk Density | 0.26–0.34 g/ml | 0.2908 g/ml |
Assay (Dried) | 97.0–102.0% | 99.50% |
Sieve Analysis (60 Mesh) | ≤8.0% | 1.01% |
Sieve Analysis (200 Mesh) | ≥45.0% | 58.49% |
Particle Size Distribution D₁₀ | ≤45 µ | 26 µ |
Particle Size Distribution D₅₀ | 70-100 | 98 µ |
Particle Size Distribution D₉₀ | ≥140 µ | 209 µ |
Microbial Limits
Test Item | Specification | Result |
Total Viable Aerobic Count | NMT 1000 cfu/g as USP/NF, Ph.Eur., BP | Complies |
Total Yeast & Mould Count | NMT 100 cfu/g as USP/NF, Ph.Eur., BP | Complies |
Staphylococcus aureus | Absent as USP/NF, Ph.Eur., BP | Complies |
Escherichia coli | Absent as USP/NF, Ph.Eur., BP | Complies |
Pseudomonas aeruginosa | Absent as USP/NF, Ph.Eur., BP | Complies |
Salmonella species | Absent as USP/NF, Ph.Eur., BP | Complies |
The raw materials, manufacturing process, and product do not contain any solvents listed in Organic Volatile Impurities (USP<467>) & residual solvents (Ph. Eur. <5.4>).
Storage recommendation: Preserve in tight containers.