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Services  Stability Storage

Magellan Pharmaceutical Development provides on-site storage services in conjunction with our in-house stability testing, or as a stand-alone service. We offer standard storage conditions as outlined in the ICH guidelines, as well as any specialized storage conditions clients may request.

Chart RecorderMagellan offers approximately 20,000 cubic feet of storage area over a broad range of storage conditions. Each stability chamber operates independently with its own temperature and, where applicable, humidity controls. All storage chambers are continuously monitored by a computerized Kaye Monitoring System and a hardwired security system. Temperature and humidity setpoint windows are ± 2° C and ± 5%RH, respectively, and failures outside setpoint ranges result in an immediate alert to the stability staff.

Additionally, all of our storage chambers are on full generator backup in case of power failure. Backup power is fully operational within 6 seconds of power failure.

Please give us a call with any questions or submit a project to us online.

Click here for a copy of Magellan's sample submission form.

Magellan's storage conditions and equipment include:

Temperature Control/Ambient:
2° C 4° C
5° C 8° C
25° C 30° C
40° C 50° C
70° C
Controlled Room Temperature (20° -25°)

Temperature/Humidity Controls:
ICH Conditions:
25° C/40%RH 25° C/60%RH
30° C/35%RH 30° C/60%RH
40° C/20%RH 40° C/75%RH
Other Available Conditions:
25° C/75%RH 30° C/70%RH
40° C/15%RH 40° C/85%RH
50° C/20%RH

Low Temperature:
-15° C -20° C
-70° C -76° C

Cycle:
2° C/40° C Cycle (1-24 Hour Cycles)

Photostability
Light Exposure/Temp. Control:

  • ICH Option 1 and 2 with Temperature Control and Monitoring at 25° C
  • Fluorescence 200-1000 foot candle
  • Room Light/CRT

Chamber Qualifications:

  • Kaye Instrument Stability Monitoring System
    (Out of range alarms and notification)
  • Full Generator Backup
  • Hardwired Security System
  • Backup Water System

Types of Sample Storage:

  • Drug Product
  • Drug Substance
  • Raw Material
  • Placebo/Excipients
  • Comparator Drug Product
  • Controlled Drugs
    * DEA Licensed Facilities for Controlled Drugs Schedules I-V

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