Product Introduction
Para-Aminobenzoic Acid (PABA) is a high-purity aromatic amine compound manufactured under a validated GMP-aligned quality system, designed for regulated pharmaceutical intermediates, cosmetic actives, and fine chemical synthesis applications.
Regulatory & Quality Compliance Profile
|
Item |
Specification |
|
Manufacturing Standard |
GMP-aligned + ISO 9001:2015 system |
|
Quality Grade |
USP / BP / EP / Industrial |
|
Purity (HPLC) |
≥ 99.0% (typical batch: 99.2–99.6%) |
|
Loss on Drying |
≤ 0.5% |
|
Residue on Ignition |
≤ 0.1% |
|
Heavy Metals (ICP-MS) |
≤ 10 ppm (typical: 2–6 ppm) |
|
Microbial Limit |
Compliant (Pharma grade batches) |
|
Residual Solvents |
USP <467> compliant |
Each batch is released only after QA/QC approval with full analytical verification.
Manufacturing System
Our production is based on a closed, validated synthesis and purification system designed for consistent impurity control and reproducibility.
Raw Material Qualification (Critical Control Point)
Incoming raw materials tested via IR identity confirmation
HPLC pre-screening for impurity profiling
Approved supplier qualification under audit system
COA reconciliation before production release
Controlled Chemical Synthesis
Reactor systems: 200L–5000L stainless steel GMP-grade reactors
Temperature precision: ±1°C controlled reaction environment
Real-time monitoring: pH, conversion rate, reaction kinetics tracking
Batch record fully digitized and traceable
Purification & Crystallization
Multi-stage recrystallization (solvent optimization system)
Controlled impurity rejection via temperature gradient crystallization
Vacuum-assisted filtration to minimize thermal degradation
Drying & Particle Engineering
Low-temperature vacuum drying (API-safe conditions)
Controlled micronization for uniform particle distribution
Batch-specific particle size adjustment available
Final Quality Release (QC Gate)
HPLC assay verification
GC residual solvent profiling
ICP-MS heavy metal detection
Microbial compliance testing (pharma-grade batches)
Final QA release authorization required
Quality Control System
|
Test Item |
Method |
Acceptance Criteria |
|
Assay Purity |
HPLC |
≥ 99.0% |
|
Identity |
IR Spectroscopy |
Conforms |
|
Residual Solvents |
GC |
USP <467> compliant |
|
Heavy Metals |
ICP-MS |
≤ 10 ppm |
|
Moisture Content |
Karl Fischer |
≤ 0.5% |
|
Microbial Limit |
Pharmacopeia |
Compliant |
Documentation per batch:
- Certificate of Analysis (COA)
- Safety Data Sheet (SDS/MSDS)
- Full traceability batch record
- Optional third-party verification (SGS / Eurofins)
Application Areas
Pharmaceutical Intermediates
Local anesthetic synthesis intermediates
API intermediate for specialty formulations
R&D pharmaceutical chemical reagent
Nutraceutical & Health Sciences
Skin and hair formulation ingredient systems
Antioxidant pathway nutritional formulations
Vitamin B-complex derivative structures
Cosmetics & Personal Care
UV absorption functional ingredient
Skin conditioning formulation additive
Emulsion stabilization system component
Industrial Fine Chemicals
Azo dye intermediate synthesis
Polymer additive precursor
Aromatic building block for fine chemistry
Supply Chain Reliability & Manufacturing Capacity
Annual production capacity: 120+ metric tons
Reactor scale: 200L–5000L multi-line production system
MOQ: 1 kg (sample validation available)
Lead time:
Samples: 3–7 days
Bulk orders: 7–15 days
Global shipping: Air / Sea freight (EXW / FOB / CIF)
Packaging & Export Compliance
Standard Industrial Packaging
Double-layer moisture-proof PE liner
25 kg fiber drum (sealed + tamper-evident)
Desiccant included for stability control
OEM / Retail Packaging
1 kg / 5 kg aluminum foil vacuum packaging
QR-based traceability system
Anti-counterfeit sealing available upon request
Logistics Support
Express samples: DHL / FedEx / UPS
Bulk shipping: Air / Sea freight
Non-DG export documentation support available
Certification & Compliance Framework
- ISO 9001:2015 certified manufacturing system
- GMP-aligned production environment
- HACCP-based quality risk control system
- Third-party testing support: SGS / Eurofins
- Full regulatory documentation package available
All certifications are verifiable upon request (audit support available for qualified buyers).
OEM / ODM Technical Customization Capability
|
Category |
Options |
|
Purity Levels |
98% / 99% / USP / BP / EP |
|
Particle Size |
80 mesh / 100 mesh / ≤10 μm |
|
Form |
Crystal / micronized powder |
|
Packaging |
1 kg / 5 kg / 25 kg |
|
Documentation |
COA / MSDS / TDS / Full dossier |
|
Testing |
SGS / Eurofins / customer-designated lab |
FAQ
Q: Can COA and MSDS be provided before purchase?
A: Yes. Full regulatory documentation is available for technical and compliance review prior to ordering.
Q: Do you support USP/BP/EP compliance batches?
A: Yes. We produce multiple regulatory-grade batches depending on target market requirements.
Q: Can third-party testing be arranged?
A: Yes. SGS, Eurofins, or customer-designated laboratories are supported.
Q: How is batch consistency ensured?
A: Through validated SOP-controlled synthesis, real-time process monitoring, and HPLC-based statistical batch release control.
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