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.