Laboratory Testing
Laboratory and Analytical Testing Services for Enzymes
Measuring enzyme activity is a precise undertaking that requires technical knowledge, skill, and technique as well as modern laboratory instruments and facilities. At Specialty Enzymes and Biotechnologies, we have both. In addition to the enzyme products we manufacture and supply, we also provide cGMP certifiable laboratory services. Enzyme identification, activity, and stability, as well as testing for heavy metals and microbial pathogens are among the lab services we provide to our customers. Need a third-party certificate of analysis? We can provide it.
Enzymes Assays – FCC, USP, FIP, JP
ENZYMES | TESTING METHOD | BRIEF DESCRIPTION |
α-Amylase (pancreatin) | USP | Starch Hydrolysis as USP |
α-Amylase (bacterial) | FCC | Starch Hydrolysis as BAU |
α-Amylase (nonbacterial) | FCC | Starch Hydrolysis as DU |
Bromelain | FIP, CDU, PU or GDU method | Hydrolysis of Gelatin |
Catalase | WM | Breaking down of hydrogen peroxide |
Cellulase | FCC | Cellulose viscosity reduction |
Cellulase | CMC | Cellulose DNSA colometric |
Chymotrypsin | FCC or USP | Hydrolysis of N-acetyl-L-Tyrosine ethyl ester |
Diastase | FCC | Hydrolysis of Starch |
α-Galactosidase | FCC | Hydrolysis of p-Nitrophenyl a-D-galactopyranose |
β-glucase | FCC | Hydrolysis of Lichenin |
β-Glucosidase | FCC | Hydrolysis of cellobiose |
Hemicellulase | FCC | Hydrolysis of bean gum and monitor viscosity change |
Invertase (Sucrase) | FCC | Hydrolysis of sucrose and optical rotation measurement |
Lactase | FCC, ALU | Using ONPG substrate |
Lipase – Pancreatin | USP | Hydrolysis of fatty acids and titration as USP |
Lipase – Microbial | FCC, FIP | Hydrolysis of model fatty acids and titration as FIP |
Nattokinase | Fibrinolytic method | Fibrinolytic activity in fibrin |
Papain | USP | Casein hydrolysis |
Pepsin | USP | Hemoglobin as substrate |
Peroxidase | WM | Oxidation by H2O2 of a substrate |
Protease –Pancreatin | USP | Hydrolysis Casein as USP |
Proteolytic Activity – Plants | FCC | Hydrolysis of Casein as PU |
Proteolytic – Bacterial | FCC | Hydrolysis of Casein as PC |
Proteolytic – Fungus | FCC | Hydrolysis of hemoglobin as HUT or of Casein as SAP |
Pectinase | AJDU or VPLA | Using apple juice, pectin as substrate |
Lysozyme | FCC | Mycoccus as substrate |
Hemicellulase | FCC | Viscosity |
Trypsin | FCC | Hydrolysis of N-benzoyl-L-arginin ethyl ester |
Xylanase | Megazyme | Megazyme xylanase tablet |
Enzyme Product Testing for Regulatory Requirements
MICROBIOLOGY
TESTING | METHOD |
Total Plate Counts | FDA BAM |
Yeast and Mold | FDA BAM |
Coliform | FDA BAM |
E.coli | FDA BAM |
Salmonella | FDA BAM |
Antibiotic Activity | USP |
Gram Stain | USP |
Probiotic Cell Count | AOAC |
IDENTIFICATION
TESTING | METHOD |
ID | FT-IR |
ID | HPLC |
IMPURITY
TESTING | METHOD |
Mycotoxsin | AOAC |
Endotxsin | AOAC |
HEAVY METALS
HEAVY METAL | METHOD |
Lead | ICP-MS |
Mercury | ICP-MS |
Arsenic | ICP-MS |
Cadimium | ICP-MS |
Zinc | AOAC |
SINGLE ENZYME PRODUCT STABILITY
PERIOD | METHOD |
1 Year | Standard SOP |
2 Year | Standard SOP |
MULTIPLE-ENZYMES PRODUCT STABILITY
PERIOD | METHOD |
1 Year | Standard SOP |
1 Year | Standard SOP |
Stability can be tested for capsule, tablet or bulk forms. Stability data will be reported in details with standard format to meet the regulatory requirements.