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 laboratory services.

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

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Pharmacokinetics (PK) Testing

Pharmacodynamics (PD) Testing

ADME Testing

Sterility Testing

Pyrogens Testing

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Raw Material Testing

Finished Product Quality Control Release Testing

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Method Development Testing

Method Validation Testing

Drug Release/Dissolution Testing

Extractable Testing

Leachable Testing

Elemental Impurities Testing

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Child-Resistant Packaging Testing

Container Closure Integrity Testing (CCIT) Testing

High Throughput Screening Testing

Reverse Pharmacology Testing

Excipients Testing

Active Pharmaceutical Ingredient API Testing

Toxicology Testing

Toxicity Testing

Microbiology Testing

Strength Testing

Quality Testing

Purity Testing

Consistency Testing

Acid Insolubles Testing

Acid Solubles Testing

Alkali Solubles Testing

Alkalinity Testing

Appearance Testing

Boiling Point Testing

Congealing Temperature Testing

Flash Point Testing

Melting Point Testing

Freezing Point Testing

Hardness Testing

Heat of Combustion Testing

Preservatives Testing

Loss on Drying (under Vacuum) Testing

Loss on Ignition Testing

Melting Point Testing

Mineral Analysis Testing

Non-aqueous Titration Testing

Normality Testing

Organic Acids Testing

Organic Extractives Testing

Oxidizing Substances Testing

Peroxide Value Testing

Pour Point Testing

Reactivity Testing

Reactivity to Water Testing

Reducing Substances Testing

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

Talc Testing

Titration Curve Testing

Total Halides Testing

Total Reducing Compounds Testing

Unburned Carbon Testing

Uncarbonized Constituents Testing

Unsaponifiable Matter Testing

UV Absorption Testing

Volatile Matter Testing

Volatile Suspended Solids Testing

Weight Variation Testing

Cytotoxicity Testing

Elution Testing

Agar Diffusion Testing

Bioburden Testing

Antimicrobial Effectiveness Testing

Particulates Testing

Total Combined Mold & Yeast (TYMC) Testing

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

Project Description

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