Surinerts

IPS has been manufacturing inert microgranules for pharmaceutical use for over 40 years. IPS microgranules are used both by private formula manufacturers specializing in MODIFIED RELEASE formulations and health-care pharmaceutical industries producing ORAL CONTROLLED drug formulations. Furthermore, special types of pellets wholly manufactured utilizing FDA approved inert materials and mainly destined for pharmaceutical use are currently under development and compatibility tests-SUGAR SPHERES are neutral pellets for pharmaceutical use – Drug Master File N: 32181 – Active IV Composition: sucrose (C12, H22, O11) 62.5-91.5%, corn starch (C6,H10,O5)n 37.5-8.5% Available in standard and special sizes (from 250 to 1700 µm / 60#-12#). Other sizes could be customized. Friability test < 1.0% Stability: minimum 5 years stored in a cool and dry place (for longer storage period please ask us for storage conditions instructions)-TARTARIC ACID PELLETS - are made for pharmaceutical use – Drug Master File N: 32545 – Active IV Composition:(C4,H6,O6) 100% Available in standard and special sizes (from 355 to 1700 µm / 45#-12#). Other sizes could be customized. Friability test < 1.0% Stability: minimum 3 years stored in a cool and dry place (for longer storage period please ask us for storage conditions instructions) Surinerts are fully in compliance with: USP, EP and JP current editions High quality standards are guaranteed by analytical and microbiological quality control tests, throughout all the manufacturing steps. All the analytical tests are carried out both by an internal Analytical Laboratory and by external validated laboratories. Certificate of Analysis are issued by our QC and approved by our QA. Production is made in San Giuliano Milanese (Milan) plant and includes storage and quarantine areas, analytical laboratory, research and development departments. Approved ISO (9001).