Product Overview

Papain is a natural cysteine protease extracted from unripe papaya latex. It exhibits strong proteolytic activity across a broad pH and temperature range, making it highly suitable for industrial processing in food, pharmaceutical, and cosmetic manufacturing.

Key Advantages

Industrial Applications

Technical Specifications

Quality Assurance

• Strict batch-to-batch consistency control
• Certificate of Analysis (COA) available
• Compliant with international quality standards

• Test Item	Specification (Internal / Compendial Reference)	Method (Ref. & No.)	Result	LOD/LOQ	Uncertainty	Conclusion
  Identification	Positive (Proteolytic enzyme activity; IR spectrum concordant)	Enzymatic assay (USP <85> modified); FT-IR (Internal SOP ID-IR-017)	Conforms	—	—	Pass
  Enzyme Activity	≥ 800,000 USP U/g (on dried basis)	USP <85> Proteolytic Activity Assay (Casein digestion)	865,000 USP U/g	—	±3.5%	Pass
  Purity (Papain content)	≥ 90.0% (protein basis)	HPLC (SEC), Internal Method HM-SEC-022 (validated)	93.4%	LOQ: 0.5%	±2.0%	Pass
  Loss on Drying	≤ 7.0%	USP <731> / ChP 0831 (105°C)	4.8%	—	±0.3%	Pass
  Residue on Ignition (Ash)	≤ 3.0%	USP <281> / ChP 2302	1.2%	—	±0.2%	Pass
  pH (1% solution)	5.0 – 7.0	USP <791>	6.2	—	±0.1	Pass
  Heavy Metals (Total)	≤ 10 ppm	ICP-MS (USP <233>, Method HM-ICP-009)	3.6 ppm	LOQ: 0.1 ppm	±10%	Pass
  Lead (Pb)	≤ 3.0 ppm	ICP-MS	0.8 ppm	LOQ: 0.05 ppm	±10%	Pass
  Cadmium (Cd)	≤ 1.0 ppm	ICP-MS	<0.1 ppm	LOD: 0.05 ppm	—	Pass
  Arsenic (As)	≤ 2.0 ppm	ICP-MS	0.3 ppm	LOQ: 0.1 ppm	±10%	Pass
  Mercury (Hg)	≤ 0.1 ppm	ICP-MS	<0.05 ppm	LOD: 0.02 ppm	—	Pass
  Microbial Limits		USP <61>/<62>
  Total Aerobic Count	≤ 10⁴ CFU/g	Plate Count	1.5×10³ CFU/g	—	—	Pass
  Yeast & Mold	≤ 10³ CFU/g	Plate Count	120 CFU/g	—	—	Pass
  E. coli	Absent / g	USP <62>	Not Detected	—	—	Pass
  Salmonella	Absent / 25g	USP <62>	Not Detected	—	—	Pass
  Residual Solvents		GC-HS (USP <467>, RS-GC-014)
  Ethanol	≤ 5000 ppm	USP Class 3	620 ppm	LOQ: 50 ppm	±8%	Pass
  Methanol	≤ 3000 ppm	USP Class 2	<50 ppm	LOD: 25 ppm	—	Pass
  Microbial Enzyme Activity Stability	≥ 90% of initial	Internal Stability Protocol ST-ENZ-005	96.2%	—	±3%	Pass
  Particle Size	95% through 80 mesh	USP <786>	Conforms	—	—	Pass

Contact & Inquiry

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