Raw Materials - Pharmaceuticals

Whitehouse Labs is a comprehensive analytical laboratory that offers USP-NF, EP, FCC and JP Monograph testing for many raw materials used in Pharmaceuticals and Personal Care. Whitehouse Laboratories is the only FDA regulated, GMP laboratory that offers complete gas testing services following USP test procedures.   Whitehouse can assist with validation of compendial methods and verification of compendial methods.

Whitehouse Laboratories is a well known support laboratory for many pharmaceutical companies. Our highly experienced team has been providing analytical services to the pharmaceutical industry for over ten years. We offers a full suite of chemistry-based testing of raw materials which includes excipients and active API’s according to current USP, EP and JP compendial method. Our internal Quality Assurance group routinely audits each of our areas for strict compliance with cGMP requirements.

Our laboratory team can meet your needs regardless of whether you need a regular turn around time of two weeks or a rush turn around time. We have the size and capacity to meet the most demanding turnaround time requirements.

COMMON COMPLETED USP/NF COMPENDIAL ANALYTICAL TESTING SERVICES INCLUDE:

  • <181>Identification – Organic Nitrogenous Bases
  • <191> Identification Tests – General
  • <197> Spectrophotometric Identification Tests
  • <201> TLC Identification Test
  • <206> Aluminum
  • <211> Arsenic
  • <216> Calcium, Potassium, and Sodium
  • <223> limit of Dimethylaniline
  • <221> Chloride and Sulfate
  • <228> Ethylene Oxide and Dioxane
  • <231> Heavy Metals
  • <232> Elemental impurities- Limits
  • <233> Elemental impurities-Procedures
  • <241> Iron
  • <251> Lead
  • <261> Mercury
  • <271> Readily Carbonizable Substances
  • <281> Residue on Ignition
  • <291> Selenium
  • <311> Alginates Assay
  • <341> Antimicrobial Agents Content
  • <661> Containers
  • Benzyl Alcohol
  • Chlorobutanol
  • Phenol
  • Methylparaben and Propylparaben
  • <401> Fats and Fixed Oils
  • Specific Gravity
  • Melting Temperature
  • Acid Value
  • Ester Value
  • Hydroxyl Value
  • Iodine Value
  • Peroxide Value
  • Saponification Value
  • Fatty Acid Composiition
  • <415> Medical Gases Assay
  • <431> Methoxy Determination
  • <461> Nitrogen Determination
  • <466> Ordinary Impuritites

COMMON COMPLETED USP/NF ANALYTICAL TESTING SERVICES INCLUDE:

  • <469> Ethylene Glycol, Diethylene Glycol and Triethylene Glycol in Ethoxylated Substances
  • <467> Residual Solvents
  • <471> Oxygen Flask Assay
  • <525> Sulfur Dioxide
  • <591> Zinc
  • <611> Alcohol Determination
  • <616> Bulk Density And Tapped Density of Powders
  • <621> Chromatography
  • <631> Color and Achromity
  • <641> Completeness of Solution
  • <643> Total Organic Carbon
  • <645> Water Conductivity
  • <651> Congealing Temperature
  • <691> Cotton
  • <695> Crystallinity
  • <698> Deliverable Volume
  • <701> Disintegration
  • <711> Dissolution
  • <721> Distilling Range
  • <731> Loss on Drying
  • <733> Loss on Ignition
  • <741> Melting Range or Temperature
  • <781> Optical Rotation
  • <785> Osmolarity
  • <786> Particle Size Distribution
  • <788> Particulate Matter in Injections
  • <791> pH
  • <831> Refractive Index
  • <841> Specific gravity
  • <851> Spectrophotometry and Light Scattering
  • <891> Thermal Analysis
  • <905> Uniformity of Dosage Units
  • <911> Viscosity
  • <912> Rotational Rheometer Methods
  • <921> Water Determination

Other Tests:

  • Monograph-specific Chemical, Microbiological & Physical Tests
  • FCC Monograph-specific Chemical & Physical
  • European Pharmacopoeia (EP) Testing
  • Japanese Pharmacopoeia (JP) Testing
  • Physical and Physio-chemical Methods, Identification, Limit Tests, Assays, Biological Tests
  • General Tests and Monographs
  • Testing per Client/Vendor Methods
  • Validation of compendial methods
  • Verification of compendial methods

 


Angelito Mendoza
Director, Raw Material & Gas Testing
Direct: 908-823-4518
wlrawmaterials@amriglobal.com


Analytical Chemistry and
Raw Materials Testing Brochure