Pharmaceutical USP Impurity Testing


Laboratory Test Request 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)


INFORMATION

Number: 18-01899

Industry: Pharmaceuticals



Interested in learning more about this
Pharmaceuticals Laboratory Test Request?


Unlock more information about this
Laboratory Test Request


Other pharmaceuticals laboratory services.


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

  • 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

Learn more about pharmaceuticals testing and research

Need Pharmaceuticals Testing or Scientific Research?

Save time and money searching. Simply, submit a Pharmaceuticals request to find the laboratories or lab suppliers that best meet your needs.

Submit Laboratory Request

Test Request: 20-00916

FDA GMP Pharmaceutical Laboratory needed for silver hydrogen peroxide testing of the following: silver content - 0.01%... view


Test Request: 20-00910

Pharmaceutical Preclinical Contract Research Organization needed for Molecule R & D Study in-vitro assays on ACE2 recep... view


Test Request: 20-00906

Preclinical Pharmaceutical Contract Research Organization CRO needed to conduct a research study of the the antiviral ... view