Raw Materials Testing
For raw materials testing, Microbac is the choice if you need USP/NF monographs from Acepromazine maleate to Zein. Here are some of the skills Microbac can offer to you:
- Years of experience in chemical testing, physical characterization, and microbiological analysis
- Technologies to address a wide spectrum of article-specific identifications, impurity and limit tests, and assays
- The capability to execute a comprehensive list of General Chapter methods
- A superior technical staff working in strict compliance with cGMP guidelines
- Comprehensive capabilities and experience (USP/EP/JP)
- Advanced analytical expertise and equipment to provide services for highly-specialized USP testing, including headspace GC/MS for Residual Solvents <467> and optical ICP and ICP/MS for the newly proposed Heavy Metal chapters <232>, <233>, <2232>
Microbiology Testing Services
Microbac’s cGMP microbiology group performs testing as per USP/NF, EP or client methodology. We provide environmental, pharmaceutical water, raw material, API, and product testing support. Our capabilities include antimicrobial effectiveness testing <51>, harmonized microbial examination of non-sterile products- microbial enumeration <61>, <62>, testing for specified microorganisms, bacterial endotoxin-gel clot/kinetic/turbidimetric <85>, microbiological procedures for testing nutritional and dietary supplements <2021> & <2022>, and microbiological recovery studies, including MD/MV.
For Pharmaceutical purposes, Microbac also performs microbiology and TOC testing of water for qualification.