Let Alcami support the release of your raw materials

Comprehensive Capabilities | Outstanding Compliance History


Our team of professionals has a strong scientific understanding of the compendia and is highly experienced in all the various techniques. Our aim is to provide exceptional customer service delivering high quality results on time, every time.

We have a strong history of regulatory compliance, and we routinely perform testing of all phases of development to include significant commercial support.

Alcami has a solid quality management system with strong procedures to onboard new compendia methods.  Additionally, Alcami is proactive and we stay current with compendial updates and support the modernization of the compendial methods and associated method verifications. 

We would love to partner with you to help support all your raw material testing needs.



  • Wet Chemistry Testing

  • Fourier-Transform Infrared Spectroscopy

  • Liquid Chromatography (HPLC, UPLC, Ion Chromatography, and TLC)

      • Detectors:  UV, PDA, CAD, RI, FL, ELSD, Conductivity, EC, MS

  • Gas Chromatography

      • Direct Injection and Headspace

      • Detectors:  FID, TCD

      • USP <467>, Residual Solvents

  • Ultraviolet-Visible Spectroscopy

  • Atomic Absorption Spectroscopy

  • Inductively-Coupled Plasma with Mass Spectroscopy

  • Titrations

      • Potentiometric

      • Karl Fischer and Coulometric Karl Fischer Testing including CKF Oven


  • XRPD

  • Viscosity

  • Particle Size Analysis (Sieve, Malvern 3000, Malvern Zetasizer, Sympatec, MFI)


Years of compendia experience including USP, Ph.Eur. BP, CP, FCC, ACS


Day Turnaround Times



Alcami’s scientists have more than 40 years experience developing analytical methods and procedures to support drug development and manufacture. Equipped with first-in-class lab and process analytical technologies, our labs are flexible and designed to achieve optimal results in an efficient and timely manner.


  • Compendial monograph testing per the USP, EP, BP, JP, FCC, ACS

  • Analytical method development, verification, transfer, and validation studies for small molecules and biopharmaceuticals

  • Drug substance reference standard characterization studies

  • API characterization

  • Heavy metals, trace metal impurities, and elemental impurities testing per USP <232>, <233>

  • Organometallics

  • Catalyst Control

  • Residual solvents as per USP <467>

  • Container and closure system integrity testing by vacuum and pressure decay

  • Disinfectant qualification and disinfectant efficacy studies

  • Liquid chromatography

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At Alcami, we combine decades of microbiological expertise, developed from serving the biotech, pharmaceutical, and medical device industries, to provide the most current and effective methodologies for developing our customers’ biologic and biopharmaceutical products. 


  • Analysis of non-sterile products

  • Antimicrobial effectiveness (preservative efficacy) validation and testing

  • Biological indicator total viable spore count, purity, and post-exposure testing

  • Container closure integrity testing (microbial ingress and dye immersion)

  • Disinfectant efficacy/disinfectant qualification studies

  • Endotoxin indicator testing for depyrogenation studies

  • Environmental monitoring and facility support

  • Gel clot limulus amebocyte lysate (LAL) assay

  • Incubation and enumeration of environmental monitoring plates

  • Inhibition/enhancement studies

  • In-use admixture studies

  • Kinetic chromogenic LAL assay | Kinetic turbidimetric LAL assay

  • Method suitability

  • Microbial assay

  • Microbial enumeration and validation

  • Microbial identification (genotypic)

  • Microbial limits test

  • Pharmaceutical water system validation and routine testing (WFI, purified water, clean steam)

  • Protocol-generated studies in support of regulatory filings

  • Rapid sterility

  • Sterile product testing

  • Sterility testing by membrane filtration and direct transfer with barrier isolator technology

  • Tests for specified organisms


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