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ICBR
ICBR
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stability studies Service

performing stability studies compliant with ICH guidelines and Egyptian guidelines

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+ 1 (38) 776-068

HPLC

HPLC

systems with 3 different detectors (PDA_RI_ fluorescence)
stability chamber

stability chamber

system control humidity and temperature
• Weighing room

• Weighing room

Analytical balance

Accelerated stability studies: Evaluation of product stability upon storage at 40°C ± 2 and 75 % ± 5 RH
Long term stability study: Evaluation of product stability upon storage at 30°C ± 2 and 65 % ± 5 RH
Analytical method development and validation, for stability samples evaluation during incubation period. 

Long-Term Testing

racks the product under normal storage conditions for its full shelf life.

Accelerated Testing

Uses higher heat and humidity to speed up breakdown and predict shelf life.

Intermediate Testing

Used when accelerated tests show small problems, testing conditions between long-term and accelerated
Affordable
Cost
Quality
of Work

Physical Tests

Chemical Tests

Microbiological Tests

ICH

compendial pharmacopoeia

In-house

In-use stability studies evaluate the chemical, physical, microbiological, and functional integrity of a pharmaceutical product after opening, reconstitution, or dilution

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