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Laboratory Test Request Details

Pharmaceuticals Test Request


Request: 18-01899

Status: Closed


Title:

Pharmaceutical USP Impurity Testing

Description:

Large Pharmaceutical Company needs Analytical Chemistry Laboratory for USP Impurity Testing: . Limit of xxxxx-isomer and other Impurities (by HPCE): Current USP-NF
Buffer: 19.1 g/L of sodium borate decahydrate in water. Adjust with phosphoric acid to a
pH of 2.2.

Run buffer: 50 mg/mL of hydroxypropylcyclodextrin in Buffer

Diluent: 0.02 M hydrochloric acid

Internal standard solution: 0.2 mg/mL of tryptamine hydrochloride in Diluent

System suitability solution: 0.01 mg/mL of tryptamine hydrochloride from the Internal standard solution, 1 mg/mL of USP xxxxx RS, and 0.01 mg/mL each of USP xxxxx Related Compound F RS, USP xxxx Related Compound G RS, and USP xxxx R-Isomer RS, in Diluent

Standard solution: 0.01 mg/mL of tryptamine hydrochloride from Internal standard solution and 0.001 mg/mL of USP xxx RS in Diluent

Sample solution: 0.01 mg/mL of tryptamine hydrochloride from Internal standard solution and 1 mg/mL of xxx in Diluent. Filter the solution and protect from light.

Electrophoretic system

Mode: CE

Detector: UV 200 nm

Column: 75-µm × 50-cm uncoated fused-silica

Applied voltage: 15 kV

Run time: 1.5 times the migration time of xxxx

System suitability

Samples: System suitability solution and Standard solution
[Note-See Table 1 for relative migration times.]

Suitability requirements

Resolution: NLT 1.5 between xxxx and xxx R-isomer peaks, System suitability solution

Relative standard deviation: NMT 5% for the peak response ratio of xxxx and tryptamine peaks, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the corrected peak responses:

Result = (r/m)

r = peak response
m = migration time of the peak (min)


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Contract Laboratory can help you with all your Pharmaceuticals testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs including:

  • Drug Discovery Testing
  • Drug Development Testing
  • Non-Clinical Study Testing
  • Preclinical Study Testing
  • Clinical Trials Testing
  • Pharmacokinetics (PK) Testing
  • Pharmacodynamics (PD) Testing
  • ADME Testing
  • Sterility Testing
  • Pyrogens Testing
  • Endotoxins Testing
  • Raw Material Testing
  • Finished Product Quality Control Release Testing
  • Real-Time Stability Testing
  • Accelerated Stability Testing
  • Method Development Testing
  • Method Validation Testing
  • Drug Release/Dissolution Testing
  • Extractable Testing
  • Leachable Testing
  • Elemental Impurities Testing
  • Packaging Testing
  • 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
  • Total Aerobic Microbial Count (TAMC) Testing
  • Testing

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