PHASE 1 DELIVERABLE
Botanical Source Qualification Dossier
AMX-B01 — Geniposide-Enriched Purified Botanical API
Document Code: SCF-AMMONEX-HE-AMXB01-P1-0001
Trigger Executed: SOURCE QUALIFY
Development Stage: Botanical Source Qualification
Objective:
Establish a fully traceable, authenticated, pharmaceutically suitable botanical source of Genipa americana capable of supporting API development, GMP manufacturing, regulatory filings, and long-term commercialization.
1.0 BOTANICAL IDENTITY
Taxonomic Classification
Category | Designation |
Kingdom | Plantae |
Order | Gentianales |
Family | Rubiaceae |
Genus | Genipa |
Species | Genipa americana L. |
Common Names
Region | Common Name |
Brazil | Jenipapo |
Peru | Huito |
Colombia | Jagua |
Amazon Basin | Genipa |
2.0 TARGET PLANT PART SELECTION
Candidate Plant Components
Plant Part | Geniposide Potential | Development Priority |
Fruit Pulp | High | Primary |
Immature Fruit | Very High | Primary |
Seeds | Moderate | Secondary |
Leaves | Low | Tertiary |
Bark | Low | Excluded |
Selected Source Material
Immature Fruit and Fruit Pulp
Selection Rationale
- Highest expected iridoid concentration
- Consistent harvesting feasibility
- Reduced contaminant burden
- Favorable extraction profile
3.0 SOURCE GEOGRAPHY ASSESSMENT
Candidate Collection Regions
Region A
Western Amazon
Countries:
- Peru
- Colombia
- Ecuador
Region B
Central Amazon
Countries:
- Brazil
Region C
Northern Amazon
Countries:
- Venezuela
- Guyana
Preferred Development Region
Brazilian Amazon
Reasons:
- Established agricultural infrastructure
- Traceable supply chain potential
- Commercial-scale sourcing feasibility
- Regulatory documentation accessibility
4.0 BOTANICAL AUTHENTICATION PROGRAM
Tier 1 — Macroscopic Authentication
Required Characteristics
- Fruit morphology
- Seed morphology
- Color profile
- Harvest maturity index
Deliverable
Botanical Identification Manual
Tier 2 — Microscopic Authentication
Required Assessments
- Cellular architecture
- Diagnostic tissue markers
- Histological reference atlas
Deliverable
Microscopy Authentication Package
Tier 3 — Genetic Authentication
Methodology
DNA Barcoding
Potential markers:
- rbcL
- matK
- ITS
Acceptance Criterion
≥99% sequence identity to authenticated Genipa americana reference material
Tier 4 — Chemical Authentication
Analytical Platform
- HPLC
- UPLC
- LC-MS
Marker Compound
Geniposide
Secondary Markers
- Genipin
- Related iridoids
Deliverable
Reference Chromatographic Fingerprint
5.0 RAW MATERIAL SPECIFICATIONS
Identity
Must pass:
- Taxonomic verification
- DNA verification
- Chemical fingerprint verification
Purity Requirements
Parameter | Specification |
Foreign matter | ≤2% |
Moisture | ≤10% |
Visible contamination | None |
Adulteration | Not detected |
Heavy Metals
Required testing:
- Lead
- Cadmium
- Mercury
- Arsenic
Must meet pharmaceutical limits.
Microbiological Standards
Required testing:
- Total aerobic count
- Yeast and mold
- Enterobacteriaceae
- Salmonella
- E. coli
Pesticide Assessment
Required:
- Multi-residue screen
- Organophosphate screen
- Herbicide screen
6.0 SUPPLY CHAIN QUALIFICATION
Supplier Qualification Program
Required Documentation
- Collection records
- Harvest records
- Geographic traceability
- Sustainability documentation
Chain-of-Custody Requirements
Every batch must contain:
- Source region
- Collection date
- Batch number
- Processing location
7.0 SUSTAINABILITY ASSESSMENT
SCF Sustainability Requirements
Harvesting
- Non-destructive collection preferred
- Replanting strategy required
- Biodiversity protection measures
Environmental Monitoring
Annual evaluation:
- Population stability
- Habitat preservation
- Supply continuity
8.0 GENIPOSIDE REFERENCE STANDARD PROGRAM
Primary Standard
Pharmaceutical-grade Geniposide
Purity Requirement
≥98%
Analytical Qualification
Methods:
- HPLC
- LC-MS
- NMR
Purpose
Establish API identity benchmark.
9.0 BOTANICAL RISK ASSESSMENT
Risk | Impact | Mitigation |
Geographic variability | High | Multi-region sourcing study |
Seasonal variability | Moderate | Harvest-window control |
Marker-content variability | High | Geniposide release specification |
Adulteration | Moderate | DNA authentication |
Microbial contamination | Moderate | GMP handling |
10.0 SOURCE QUALIFICATION DECISION
Qualification Status
PROVISIONALLY ACCEPTED
Botanical source:
Genipa americana
Plant part:
Immature fruit / fruit pulp
Primary marker:
Geniposide
Advancement Criteria Met
✓ Botanical relevance
✓ Ethnomedical justification
✓ Target-pathway alignment
✓ Commercial sourcing feasibility
✓ Purification suitability
PHASE 1 DECISION GATE
Status
ADVANCE TO PHASE 2
Required Next Trigger
EXTRACT API
Phase 2 will generate:
- Botanical extraction strategy
- Solvent selection matrix
- Geniposide enrichment workflow
- Fractionation process
- Purification process
- Yield optimization strategy
- API intermediate specifications
MASTER REGISTRY INDEX
SCF-AMMONEX-HE-AMXB01-P1-0001 — Botanical Source Qualification Dossier
SCF-AMMONEX-HE-GENIPA-0002 — Genipa americana Source Program
SCF-AMMONEX-HE-GENISTD-0003 — Geniposide Reference Standard Program
SCF-AMMONEX-HE-SUPPLY-0004 — Supply Chain Qualification
SCF-AMMONEX-HE-BAUTH-0005 — Botanical Authentication Framework
SCF-AMMONEX-HE-AMXB01-P2-0006 — Extraction Program Initiation