EXPORT QUALITY STANDARDS
Global Regulations
Key Requirements
- FDA 21 CFR 111 Compliance
- AKA GMP 4.0 Certified
- BPOM CPOTB Standard
- Annual Audits Required
Full compliance required for export
AKA GMP 4.0 Requirements
Core Requirements
- FDA 21 CFR 111 Alignment
- Thorough Identity & Purity Audits
- Free from Heavy Metals and Pathogen
Compliance Details
- KCPA-Compliant Labeling System
- Independent Third-Party Annual Audit
- Standardized BPOM CPOTB Protocols
Testing Requirements
- Microbiology (TAMC/TYMC)
- Heavy Metals (Pb, Cd, Hg, As)
Documentation
- Specific COA per-batch
- Traceability
Standards based on AKA GMP 4.0 Guidelines
Strict Verification
INDUSTRIAL EXTRACTION TECHNOLOGY
4-Step Production Process
Stage 1
Pre-process & Milling
- Physical Impurity Separation & Washing
- Grinding Leaves into Powder
- Homogenization of Particle Size ≤600μm
Stage 2
Solvent Extraction
- Extraction using ethanol/water solvent
- Controlled heating
for efficiency - Consistent agitation attracts alkaloids
- Filtration of the
extract liquid
Stage 3
Vacuum Concentration
- Evaporation of solvent
at low temperature - Vacuum protects stability of alkaloids
- Prevents compound degradation
Stage 4
Spray / Freeze Drying
- Converting liquids into
pure powder - Advanced dry systems
- Standard pharmacopoeia packaging
QUALITY CONTROL & TESTING
Comprehensive quality assurance from sampling to certification.
Testing Categories
COA per Batch
Alkaloid assay, moisture, ash
PASS
Microbiology
TAMC / TYMC, Pathogen
PASS
Heavy Metals
Pb, Cd, Hg, As
PASS
Pesticides
Residue analysis
PASS
LABORATORY TESTING WORK FLOW
01 Sampling
AQL-based
02 Preparation
Homogenization
03 Testing
Lab Analysis
04 Reporting
COA & Docs
| Parameter | Specification | Result | Status |
|---|---|---|---|
| Mitragynine | >1.5% | 1.8% | PASS |
| Moisture | <10% | 8.5% | PASS |
| Heavy Metals | <0.5 ppm | 0.3 ppm | PASS |
| Microbiology | <1000 CFU/g | 850 CFU/g | PASS |