
Centralised Stability Centre
Akums has 10 State-of-the-Art, walk-in Stability Chambers and 1 Photo Stability Chamber equipped to conduct Stability Studies as per ICH (Q1AR2) guidelines.
Stability for products is performed at various conditions by maintaining the environmental conditions as per regulatory requirement using several AHUs, chillers, dehumidifiers, etc.
This world-class centralized Stability Centre has Independent Quality Control Lab to ensure strict regulatory compliance under the supervision of a centralized CQA team. There is a dedicated QC Department well-equipped with highly sophisticated equipment as per CFR compliance.
Akums’s NABL approved laboratory is fully equipped for Physical and Metallurgical testing, Microbiological testing, Chemical testing, Pharmacological testing, etc. to conduct periodic quality reviews of products, processes, & procedures. Equipped with the latest instruments like TOCA (Total Organic Carbon Analyzer), FTIRs, HPLCs, Atomic Absorption Spectro-Photometers, Gas Chromatography-HS-Auto Sampler with FID, TCD, ECB
Stability Chambers with following Capacity are installed in the Centralized Stability Study Facility:
Stability Chamber (Temperature ± 2°C /Humidity ± 2%RH) |
Capacity (Liters) |
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40°C / 75%RH | 50,000 |
25°C / 60%RH | 2.0 Lac |
30°C / 65%RH | 1.0 Lac |
30°C / 75%RH | 2.0 Lac |
30°C / 75%RH | 2.0 Lac |
Stability Chamber (Temperature ± 2°C /Humidity ± 2%RH) |
Capacity (Liters) |
---|---|
30°C / 65%RH | 22,500 |
30°C / 35%RH | 22,500 |
25°C / 40%RH | 22,243 |
40°C / NMT 25%RH | 2000 |
2°C to 8°C | 800 |
Photostability Chamber | At UV-Visibile Light | 200 Litres |
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