Pharmacopeial Specifications for Cellulose Acetate
| Test | PhEur 2005 | USPNF 23 |
|---|---|---|
| Identification | ✓ | ✓ |
| Loss on Drying | ≤5.0% | ≤5.0% |
| Residue on Ignition | ≤0.1% | ≤0.1% |
| Free Acid | ≤0.1% | ≤0.1% |
| Heavy Metals | ≤10 ppm | ≤0.001% |
| Microbial Limits (CFU/g) | ≤10³ (aerobic), ≤10² (fungi/yeast) | — |
| Organic Volatile Impurities | — | ✓ |
| Acetyl Group Assay | 29.0–44.8% | 29.0–44.8% |
Applications in Pharmaceutical Formulation or Technology
Cellulose acetate is used in sustained-release drug delivery, taste masking, and film coatings. It serves as a semipermeable membrane in osmotic pump tablets and implants, enabling controlled drug release. Additionally, it is used in transdermal patches, microparticles, and extended-release tablet matrices.
Comment
Cellulose acetate is widely utilized for controlled drug release, but formulation parameters such as plasticizer content and active-to-polymer ratio should be carefully optimized to achieve the desired release profile. Additionally, potential interactions with active ingredients should be evaluated to ensure stability and efficacy.
