Stability Study Testing for Pharmaceuticals as per ICH Standards (Accelerated and Real-Time Stability Studies)

Project Description

Contract laboratory needed to conduct Stability Testing Services for Pharmaceuticals per the ICH and FDA guidelines.
If so, we are interested in the following:
Accelerated Stability Study kept at 40°C +/- 2°C RH +/- 5% RH for 12 months to simulate 3 years at room temperature per ICH Q1A guidelines.
? Sample to test the product quality will be collected at time points (0, 3, 6 months)
Real-Time Stability Testing Study kept at 25°C +/- 2° C RH +/- 5% for 36 months at room temperature per ICH Q1A guidelines.
? Sample to test the product quality will be collected at time points (0 ,3 ,6, 9, 12, 18, 24, 36 months)
Both studies will need to have the following tests at each time point:
? Pharma USP 61 (total aerobic count, total yeast & mold)
? USP 62 (Absence of E coli)
? USP 631 color test
? USP odor test
? USP Appearance test
? Exaprin Max (Acetaminophen 250mg, Aspirin 250mg, Caffeine 5mg) USP assay
? USP weight variation, GW
? USP weight variation, NW
? USP Average Net Weight
? USP 701 Disintegration
? USP 231 Elemental Analysis (Heavy Metals)
? Predict degradation at the recommended storage conditions using known relationships between the acceleration factor and degradation rate. (Perform only on Accelerated Stability Study).

Project Information

Number:24-01002

Industry:Pharmaceuticals

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Other Pharmaceuticals testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs include :

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Alkalinity Testing

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Normality Testing

Organic Acids Testing

Organic Extractives Testing

Oxidizing Substances Testing

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Reactivity to Water Testing

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Refractive Index Testing

Residue on Evaporation Testing

Residue on Ignition Testing

Saponification Value Testing

Sieve Analysis Testing

Silver Reducing Substances Testing

Silicon Testing

Sulfur Testing

Sodium Testing

Specific Gravity Testing

Specific Rotation Testing

Sugars Testing

Sulfur Compounds Testing

Surfactants Testing

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Total Halides Testing

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Unburned Carbon Testing

Uncarbonized Constituents Testing

Unsaponifiable Matter Testing

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Stability Study Testing for Pharmaceuticals as per ICH Standards (Accelerated and Real-Time Stability Studies)

Project Description

Project Information

Test Request: 24-01179

Test Request: 24-01173

Test Request: 24-01170