Summary of the Available Data for the Sterile Injection Applications Submitted between September 2010 and July 2011

Submission DateDosage FormRoute of AdministrationContainer TypeContainer VolumeSubvisible Particle LimitMethod≥10 um Particle Count Average ± SD≥25 um Particle Count Average ± SDVisible Particle SpecificationVisible Particle Results (Stability Batches)
9/28/2010liposomesSurgical site injectionGlass vials10 mL and 20 mL6000/600 per container<788>200.2 ± 105.18.5 ± 5.7“Free of Foreign Matter”All lots “Free of Foreign Matter”
9/29/2010solutionIntramuscular or subcutaneousGlass cartridge0.15 or 0.3 mL6000/600 per container<788>1.7 ± 1.20 ± 0“Free of precipitates”“conforms”
10/5/2010Lyophilized powderIntravenous, intramuscular or sub-cutaneousPolypropylene vial1 mg6000/600 per container<788>13.7 ± 11.90.3 ± 0.6“The constituted solution is essentially free from particles of foreign matter that can be observed on visual inspection” USP<1>“Essentially Free from visible particles”
11/3/2010Lyophilized powderIntravenous infusionGlass vial20 mg or 100 mg6000/600 per container<788>64.6 ± 93.410.4 ± 19.9No specification providedN/A
12/7/2010solutionIntravenousGlass vial3000/300 per container<788>130.8 ± 36.411.5 ± 7.0No specification providedN/A
1/13/2011solutionIntravenousNon-PVC bags100 mL6000/600 per container<788>133.3 ± 57.70 ± 0“Free of Visible Particles” USP <1>“Complies”
1/14/2011solutionIntravenous, intramuscularGlass cartridges1 mL6000/600 per container<788>121.5 ± 92.61 ± 1.4“Solution must be clear. Solution must not contain one or more particles which are visible.”“Pass”
1/31/2011SolutionIntravenous, intramuscular or sub-cutaneousPre-filled plastic syringe1–10 mL6000/600 per container<788>423 ± 157.96.8 ± 11.7No specification providedN/A
2/25/2011SolutionSubcutaneousPre-filled glass syringe3 mL6000/600 per container<788>153 ± 33.82.3 ± 2.3European Pharmacopeia. 2.9.20 Acceptance Criteria—“Clear”“No significant change in visible particulate matter”
4/7/2011Lyophilized powderIntravenous, intramuscular or sub-cutaneousGlass vials1 mg6000/600 per container“in-house”025“Solution is Clear”, USP“Reconstituted Solution is Practically Free from Visible Particulate Matter”
4/7/2011solutionIntravitrealGlass vial1 mL6000/600 per container<788>, 2.9.290 ± 00 ± 0Solution must be clear. Solution must not contain one or more particles that are visible upon attentive examination (USP<1> European Pharmacopeia. 2. 2.1.“Pass”
4/29/11solutionIntravenousPolypropylene vials1 mL–20 mL6000/600 per container<788>32.1 ± 42.514.1 ± 24.5“Free from Visible Particles”“complies”
5/23/11SolutionIntravenous or subcutaneousGlass pre-filled syringe or glass vials0.5–2 mL6000/600 per container<788>234.3 ± 280.92.7 ± 3.1“Free of Visible Particulates” Internal SOP“Free of Visible Particles”
6/21/11solutionSubcutaneousPre-filled glass syringe1 mL6000/600 or 3000/300 if LO method failsUSP <788>694.3 ± 342.53 ± 1.3No specification providedN/A
6/30/11solutionIntravenousGlass vial2.5 mL6000/600 per container<788>, (Ph.Eur. 2.9.19)47 ± 33.11 ± 0No specification providedN/A
7/12/11liposomesIntravenousGlass vial5 mL6000/600 per container<788>59 ± 26.21 ± 0No specification providedN/A
  • SD = standard deviation.