Pharmaceutical-Grade Enzymes
Pharmaceutical-Grade Enzymes (EC Various) — USP/EP-Compliant Biocatalysts
Pharmaceutical-Grade Enzymes engineered for consistent performance in industrial and laboratory bioprocess workflows. Supplied from bovine (trypsin), porcine (pepsin), and bacterial (lysozyme) sources, plus lipase, esterase, and protease for API synthesis and downstream pharmaceutical manufacturing. Operating pH range 2.0–8.5 and temperature range 25°C–40°C. White to off-white lyophilized powder, USP/EP grade available. MOQ 100 g. Global shipments with ISO/cGMP certification and documented lot traceability.
Product Specifications
Pharmaceutical-Grade Enzymes Powder — USP/EP grade available
Activity
USP/EP grade available
Optimal pH
2.0 – 8.5 (enzyme-dependent)
Optimal Temperature
25°C – 40°C
Appearance
White to off-white lyophilized powder
Source organism
Bovine (Trypsin), Porcine (Pepsin), Bacterial (Lysozyme)
Shelf Life
24 months (sealed, -20°C)
Packaging
100 g – 25 kg / cGMP packaging
MOQ
100 g
Certifications
ISO 9001, cGMP, USP/EP, DMF available, >95% purity (HPLC)
Applications
Pharmaceutical-Grade Enzymes with documented activity for industrial bioprocessing, API production, and QC lab workflows. Reliable performance within specified pH/temperature ranges with ISO/cGMP documentation.
Pharmaceutical Manufacturing
USP/EP-grade trypsin, pepsin, and lipase for API processing, drug formulation, and pharmaceutical intermediate production.
Learn more →Cell Culture
Ultra-pure trypsin and collagenase for cell dissociation, tissue engineering, and biopharmaceutical production — low endotoxin guaranteed.
Protein Analysis
Sequencing-grade trypsin and chymotrypsin for mass spectrometry, peptide mapping, and proteomic research workflows.
Vaccine Production
GMP-documented enzymes for viral inactivation, cell harvesting, and downstream processing in vaccine manufacturing facilities.
API Processing
Pharmaceutical-grade lipase, esterase, and protease for chiral resolution, peptide synthesis, and active ingredient manufacturing.
Quality Control
Reference-standard enzymes with full CoA, HPLC purity data, and lot traceability for QC laboratories and cGMP compliance.
Why Source From Us
Pharmaceutical-Grade Quality Systems
ISO 9001 and cGMP-controlled packaging for consistent manufacturing of USP/EP-grade enzymes across batches.
Verified Purity & Full Traceability
HPLC purity data (>95%) with CoA and lot records for QA/QC labs, supporting strict regulatory and manufacturing standards.
Configured for Process Conditions
Optimized to operate within pH 2.0–8.5 and 25°C–40°C ranges for predictable activity in industrial processes.
Bulk Packaging & Rapid Fulfillment
Supply options from 100 g – 25 kg with cGMP packaging. MOQ 100 g to ease sampling, qualification, and production scaling.
Frequently Asked Questions
What does “USP/EP grade available” mean for Pharmaceutical-Grade Enzymes?
It indicates supply of enzyme grades meeting USP/EP specifications, supported by CoA and quality data for compliance in regulated manufacturing.
What are the optimal pH and temperature ranges?
Optimal pH is 2.0–8.5 depending on enzyme type, and optimal temperature range is 25°C–40°C for consistent catalytic activity.
What is the shelf life and recommended storage?
Shelf life is 24 months when stored sealed at -20°C. Follow TDS and CoA instructions for preservation of activity.
Which source organisms are available?
Available sources include bovine (trypsin), porcine (pepsin), and bacterial (lysozyme), plus other pharmaceutical-grade enzymes on request.
Do you provide purity data and documentation for QC and cGMP use?
Yes, we supply >95% purity (HPLC), full CoA, batch traceability, and DMF availability upon request for regulated applications.
Get a Free Sample & Quote
Specify your application, process conditions, and volume needs. Receive a free sample, CoA, and competitive quotation within 24 hours.
Response
Response within 24 hours
Shipping
Ships from China to 80+ countries