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Support Request Testing

    Pharmaceuticals

    Microbac offers trusted analytical testing and research services tailored to the development, approval, and manufacturing of pharmaceutical and biopharmaceutical products. We comply with Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulations, ensuring high standards in all services

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    pharmaceuticals

    Our support extends across various pharmaceutical sectors, including prescription, generic, over-the-counter (OTC) medications, animal health products, and compounding pharmacies. With a focus on regulatory compliance and ease of development, Microbac provides confidence and guidance at every stage of the product life cycle—from raw ingredient testing to final product approval.

    • Prescription and Over-the-Counter (OTC) Drugs
    • Quality Control for In Process and Release of Finished Products and Raw Materials (API and Excipients)

    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.

    Stability Studies by ICH

    • Conditions Available
      • 25°C/60% RH
      • 40°C/75% RH
      • 30°C/65% RH
      • 5°C
      • -20°C
    • Protocol Generation & testing or shipping of samples per timepoint
    • Monitored with Alarms 24/7/365
    • Automatic Emergency Power Back-up.

    Chromatography

    • HPLC coupled with DAD, UV, RI, conductivity or fluorescence detection.
    • Ion Chromatograph coupled with conductivity detection.
    • Gas Chromatography (headspace or direct) coupled with FID, TCD, ECD or FPD detection.
    • TLC

    Spectroscopy

    • Microbiology
      • GC/MS
      • ICP coupled with MS or OES
      • AAS & AAGF
      • FTIR
      • UV/Vis
      • Polarimeter

    Antiviral and Antimicrobial Drugs

    • Bacterial & Yeast Mold Plate Counts
    • Antimicrobial Efficacy Testing
    • Antiviral IC50 and viral blocking (barrier) activity
    • Endotoxin Assay
    • Mechanisms of action and viral resistance studies
    • Minimum Inhibitory Concentration (MIC)
    • Minimum Bactericidal Concentration (MBC)
    • Minimum Fungicidal Concentration (MFC)
    • Pathogen Detection
    • Zone of inhibition (ZOI)
    • Fungal Resistance

    Molecular Biology

    • Microbial ID
    • PCR
    • Next-generation sequencing
    • Residual DNA

    Physical/Wet Chemistry

    • Dissolution/Disintegration
    • Kjeldahl Determinations
    • Melting Point
    • pH
    • Refractive Index
    • Specific Gravity
    • Titrations: Manual, Autotitrator, Karl Fischer (Classical and Coulometric)
    • TOC
    • Viscosity: Capillary and Rotational

    Special Projects

    • Method Development & Validation
    • Cleaning validation
    • Process validation
    • Coupon Disinfectant Efficacy Testing (Microbes & Virus)
    • In vitro Toxicology

    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
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    Have questions or need expert testing solutions? Reach out to Microbac today, and let our team provide you with reliable and accurate testing services tailored to your needs. We’re here to support your business with trusted expertise.

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