Humectant
Vegetable Glycerin USP/EP
CAS 56-81-5
Pharmaceutical-grade glycerol from vegetable feedstocks. Identity and limits aligned to USP and European Pharmacopoeia monographs with batch CoA documentation.
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CAS 9004-34-6
Compendial microcrystalline cellulose for direct compression and wet granulation. Identity and release limits aligned with Ph. Eur., USP-NF, and JP monograph ranges — lot-specific CoA prevails.
Representative release criteria; lot-specific limits on CoA prevail.
| Appearance | White to off-white powder — |
|---|---|
| Identification | Conforms Ph. Eur. & USP |
| Loss on drying | ≤7.0 % |
| Bulk density | 0.28–0.45 g/cm³ |
| pH (10% suspension) | 5.0–7.5 — |
| Heavy metals | ≤10 ppm |
| Microbial limits | Meets Ph. Eur. — |
Column semantics are indicative; certify the grade line on your PO.
| Specification | MCC 101 | MCC 102Most requested | MCC 200 | MCC low-moisture |
|---|---|---|---|---|
| Avg. particle size (typical) | ~50 µm | ~100 µm | ~180 µm | ~100 µm |
| Intended use | Tablet binder / diluent | Direct compression | Free-flowing direct compression | Moisture-sensitive APIs |
| Loss on drying (typical) | ≤7.0% | ≤7.0% | ≤7.0% | ≤3.0% |
| Ph. Eur. monograph | ||||
| USP-NF monograph | ||||
| JP compliance | ||||
| Batch CoA |
Minimum 500 kg per grade line; mixed-grade pallets by quotation.
Lot-specific safety and release documentation.
Attach target pharmacopoeia, release geography, and lot size — we mirror the same spec table on quotations.
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