Pharmaceutical & Animal Health

How Can We Help?

Trusted analytical testing and research services support your development, approval and manufacturing of pharmaceutical, biopharmaceutical and animal health products. An experienced team of scientists works with you to design a comprehensive solution to meet the timing, measurement and data requirements specific to your project and regulatory considerations.

Microbac provides quality and safety testing throughout the product life cycle for large and small molecule drugs. We have decades of experience working with pharmaceutical and biopharmaceutical products in compliance with GLP and cGMP regulation. Our laboratories are registered with the FDA and DEA (Schedule I-V controlled substances) and are ISO 17025-accredited.

Working with pharmaceutical companies large, small and virtual, we offer methods development and validation, process validation, investigation, product development support and cleaning validation for prescription, generic, OTC, animal health, compounding pharmacies and more. From raw ingredient testing to navigating the complexities of regulation, our team works with you to ensure ease and confidence throughout the product life cycle. 

 

 

Pharmaceutical Testing Services

 Areas of Expertise

  • Raw materials (USP, Ph. Eur., JP, FCC, ACS, BP)
  • Quality control tests on raw materials, finished products, in-process testing, stability management & storage and environmental monitoring for ISO areas.
  • Dosage Forms: Parenterals, Oral Solutions, Powders, Tablets/Capsules, Creams/Ointments
  • Stability Storage: 25°C/60% RH, 40°C/75% RH, 30°C/65% RH, 5°C, -20°C, -80°C, Photostability, Cycling Studies, Custom Conditions

 

USP General Chapters Supported

  • USP <1> Injections and Implanted Drug Products (Parenterals) Product Quality Tests
  • USP <2> Oral Drug Products-Product Quality Tests
  • USP <3> Topical and Transdermal Drug Products-Product Quality Tests
  • USP <4> Mucosal Drug Products-Product Quality Tests
  • USP <51> Antimicrobial Effectiveness Testing
  • USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
  • USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
  • USP <85> Bacterial Endotoxins Test
  • USP <181> Identification-Organic Nitrogenous Bases
  • USP <191> Identification Tests-General
  • USP <197> Spectrophotometric Identification Tests
  • USP <201> Thin Layer Chromatographic Identification Tests
  • USP <211> Arsenic
  • USP <221> Chloride and Sulfate
  • USP <228> Ethylene Oxide and Dioxane
  • USP <231> Heavy Metals
  • USP <232> Elemental Impurities – Limits
  • USP <233> Elemental Impurities – Procedures
  • USP <241> Iron
  • USP <251> Lead
  • USP <271> Readily Carbonizable Substances Test
  • USP <281> Residue on Ignition
  • USP <311> Alginates
  • USP <401> Fats and Fixed Oils
  • USP <461> Nitrogen Determination
  • USP <466> Ordinary Impurities
  • USP <467> Residual Solvents
  • USP <541> Titrimetry
  • USP <621> Chromatography
  • USP <641> Color and Completeness of Solution
  • USP <643> Total Organic Carbon
  • USP <645> Water Conductivity
  • USP <651> Congealing Temperature
  • USP <697> Container Content for Injections
  • USP <698> Deliverable Volume
  • USP <701> Disintegration
  • USP <711> Dissolution
  • USP <721> Distilling Range
  • USP <730> Plasma Spectroscopy
  • USP <731> Loss on Drying
  • USP <733> Loss on Ignition
  • USP <736> Mass Spectroscopy
  • USP <741> Melting Range or Temperature
  • USP <755> Minimum Fill
  • USP <785> Osmolarity and Osmolality
  • USP <791> pH
  • USP <831> Refractive Index
  • USP <841> Specific Gravity
  • USP <852> Atomic Absorption Spectroscopy
  • USP <857> Ultraviolet – Visible Spectroscopy
  • USP <905> Uniformity of Dosage
  • USP <911> Viscosity – Capillary Methods
  • USP <912> Viscosity – Rotational Methods
  • USP <921> Water Determination