Pellet specifications arise from the regulations for pharmaceutical excipients. Cellets, which are microcrystalline pellets, are excipients. There are physical, chemical and biological specifications:
- Physical specifications: particle size distribution, loss on drying, bulk density, sphericity degree, friability, swelling index.
- Chemical specifications: identification infrared absorption, identification zinc chloride test, degree of polymerization, pH value, conductivity, ether soluble substances, water soluble substances, heavy metals, sulfated ash.
- Biological specifications: total aerobic microbial count, fungi / moulds and yeasts, E.coli Ps aergin St. Aureus, Samonella species.
Pellet specifications: parameters
Pellet specifications are given by regional pharmacopoeia which serves and defines common quality standards throughout the pharmaceutical industry in different regions world-wide. The most important pharmacopoeia are:
- Eur Ph: Pharmacopoeia Europaea, pharmaceutical standards in Europe,
- JP: Japanese Pharmacopoeia, pharmaceutical standards in Japan and
- JPE: Japanese Pharmaceutical Excipients, pharmaceutical standards for excipients in Japan,
- USP-NF: United States Pharmacopeia (USP) and the National Formulary (NF), pharmaceutical standards in USA
There are several minor national standards which needs to be considered for the respective markets.
Cellets are specified by the strictest pharmaceutical standard (Eur Ph, JP/JPE, USP/NF) for each specification. See: Cellets product information
