Product Overview
Niacinamide is a water-soluble vitamin B3 derivative used in cosmetic, food, supplement, and pharmaceutical applications.
Technical Specifications
|
Parameter Category |
Test Item |
Specification / Practical Value |
Reference Standard |
|
Identity & Compliance |
Monograph Compliance |
Complies with USP, EP, BP, FCC current editions |
All Monographs |
|
Core Purity |
Assay (Dry Basis) |
99.0%–101.0% |
USP / EP / BP / FCC |
|
Physical Properties |
Melting Range |
128°C–131°C |
USP / EP / BP |
|
Critical Impurity |
Free Nicotinic Acid (Niacin) |
≤100 ppm (Premium cosmetic grade: ≤20 ppm) |
USP / EP / BP / Cosmetic Grade |
|
Moisture & Ash |
Loss on Drying |
≤0.5% |
USP / EP / BP / FCC |
|
Residue on Ignition |
≤0.1% |
USP / EP / BP / FCC |
|
|
Heavy Metals |
Total Heavy Metals |
≤10 ppm |
USP / EP |
|
Arsenic (As) |
≤2 ppm |
FCC / Regulatory limit |
|
|
Lead (Pb) |
≤2 ppm |
FCC / Regulatory limit |
|
|
Physical Forms |
Granular |
20–80 mesh (anti-caking, good flowability) |
Manufacturer standard |
|
Powder |
≥100 mesh (fast dissolution, cold-process suitable) |
Manufacturer standard |
|
|
Application Parameters |
Solubility |
1 g/1 mL in water (highly soluble) |
USP / EP |
|
Optimum pH Range |
5.5–6.5 (reduces risk of nicotinic acid formation) |
Formulation guideline |
Compliance & Quality Certifications
|
Certification / Standard |
Scope & Relevance to Manufacturing |
|
ISO 22716:2007 |
Facility follows GMP principles for cosmetic ingredient manufacturing. |
|
EFfCI GMP Standard |
Production follows EFfCI GMP requirements for cosmetic ingredients. |
|
REACH Registration |
Complies with EU chemical safety and registration requirements. |
|
Kosher & Halal |
Provides certification for compliant consumer product manufacturing. |
|
RSPO Supply Chain |
RSPO mass balance supply chain documentation is available. |
Manufacturing Capacity & Supply Chain
Catalytic Oxidation Scaling
Liquid-phase catalytic oxidation lines are used for Niacinamide production.
DCS Hydrolysis Management
Distributed Control Systems monitor amidation parameters during production.
Controlled Crystallization Systems
Multi-stage cooling crystallization units control crystal form and particle size distribution.
Dedicated Finishing Suites
Isolated milling and classification zones include cross-contamination control procedures.
Strategic Buffer Sourcing
Managed precursor inventory protocols support raw material supply planning.
Technical Documentation & R&D Support
|
Technical Service |
Deliverable & Framework |
|
Dossier Delivery |
Provides regulatory documentation including SDS, COA, and TSE/BSE statements. |
|
HPLC Matrix Validation |
Provides HPLC method support for topical formulations. |
|
pH Stability Mapping |
Provides pH compatibility data for formulation evaluation. |
|
Skin Permeation Data |
Includes available in vitro skin absorption data. |
|
Material Compatibility |
Provides compatibility data for use with active ingredients. |
FAQ
Q: What packaging formats are commonly used to maintain product dryness?
A: Standard packaging consists of fiber drums with inner polyethylene liners to protect against moisture ingress.
Q: What measures are used during maritime transport to reduce caking risk?
A: Desiccants and temperature-controlled containers may be used during long-distance shipping.
Q: What documentation is provided with each shipment?
A: Each shipment is accompanied by a Certificate of Analysis (COA), packing list, and Safety Data Sheet (SDS).
Q: How are product quality inquiries handled?
A: Quality inquiries are reviewed through retained sample testing and specification checks.
Q: What is the process for handling damaged goods upon receipt?
A: Damage reports are typically reviewed with supporting evidence to determine appropriate resolution or replacement procedures.
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