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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
 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.

Laboratory Director

 

Dr. Hui Zhu, PhD

 

Hui Zhu, PhD, is Director of Laboratory Services at Specialty Enzymes and Biotechnologies. Dr. Zhu is responsible for management of all laboratory services including enzyme assays, maintaining GMP standards, QC/QA, managing laboratory staff and heading up research. Dr. Zhu’s impressive curriculum vitae includes the completion of two post-doctorates, the most recent of which was in tumor research at Cedars-Sinai Hospital. In addition, he was the lead author in 8 peer-reviewed journal articles and has been honored with the Ms. Ivy Wu Fellowship as well as the Distinguished Presentation Award from the American Transplantation Congress. Further, Dr. Zhu completed advanced training in compliance with GMP and GCP (good clinical practice) through the City of Hope in 2007.

Company News

Supplyside West 2016- Booth #R123

We look forward to seeing everyone at the SupplySide West Show at the Mandalay Bay in Las Vegas, NV from October 6-7.  Come see the Specialty Enzymes team at Booth #R123!

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Specialty Enzymes & Biotechnologies
13591 Yorba Ave., Chino, CA 91710
Phone: 909-613-1660 | Fax: 909-613-1663
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