Technical Data Sheet | ||||
Product | Hydroxypropyl methyl cellulose based capsule | |||
Grade | HPMC-Caps #00-T | |||
Size | #00 | |||
Body colour | Transparent | |||
Cap colour | Transparent | |||
Composition | Hypromellose, Excipients, Water | |||
EEC Nr. | E464, E418 | |||
Pharmacopeia ref. | EP / USP-NF / FCC | |||
Characteristics | ||||
Item | Unit | Specification | ||
Weight | mg | 123.0 ±8.0 | ||
Capsule length (closed) | mm | 23.4 ±0.5 | ||
Body length | mm | 20.05 ±0.4 | ||
Cap length | mm | 11.80 ±0.4 | ||
External diameter | mm | Body: 8.15-8.25 | Cap: 8.50-8.60 | |
Wall Thickness | mm | Body: 0.110±0.02 | Cap: 0.115±0.02 | |
Volume | ml | 0.93 | ||
Specifications (test method: TS.QC.C01) | ||||
Item | Unit | |||
Disintegration time | Minutes | Max. 15 | ||
Lubricant content | % | Max. 0.5 | ||
Loss on drying | % | Max. 8.5 | ||
Residue content | % | Max. 3 | ||
Heavy metals | % | Max. 0.001 | ||
Arsenic | % | Max. 0.0002 | ||
Total bacteria count | cfu/g | Max. 1000 | ||
Total yeast and mold count | cfu/g | Max. 100 | ||
Escherichia coli | Not detected | |||
Staphylococcus aureus | Not detected | |||
