Dihydroxyindoline HBr Manufacturing Specifications (CAS 138937-28-7)
- Meets stringent GMP and ISO quality standards for pharmaceutical intermediates
- Available in industrial purity ≥95% with full Certificate of Analysis (COA)
- Produced via a controlled synthesis route by premier global manufacturer NINGBO INNO PHARMCHEM CO.,LTD.
Dihydroxyindoline HBr (CAS 138937-28-7), chemically designated as 5,6-Dihydroxyindoline hydrobromide with the molecular formula C8H10BrNO2, is a critical pharmaceutical intermediate primarily used in hair dye formulations and biochemical research. As regulatory scrutiny intensifies across global markets, compliance with manufacturing, safety, and documentation protocols has become non-negotiable for B2B buyers sourcing this compound at scale.
Regulatory and Safety Documentation Requirements
Under the Globally Harmonized System (GHS), Dihydroxyindoline HBr carries the signal word “Warning” and hazard statements H302 (harmful if swallowed), H315 (causes skin irritation), H319 (causes serious eye irritation), and H335 (may cause respiratory irritation). Consequently, suppliers must provide comprehensive Safety Data Sheets (SDS) aligned with REACH, OSHA, and local chemical regulations.
For importers and formulators, a valid Certificate of Analysis (COA) is essential to verify identity, assay, residual solvents, heavy metals, and water content. Reputable manufacturers like NINGBO INNO PHARMCHEM CO.,LTD. issue batch-specific COAs that include HPLC chromatograms, melting point data, and elemental analysis—ensuring traceability and regulatory defensibility in audits.
GMP and ISO Standards in Intermediate Production
The production of 5,6-Dihydroxyindoline hydrobromide for pharmaceutical or cosmetic use demands adherence to current Good Manufacturing Practices (cGMP) and ISO 9001 quality management systems. At NINGBO INNO PHARMCHEM CO.,LTD., the entire manufacturing process is conducted in ISO-certified facilities with dedicated cleanrooms for solid-phase intermediates, minimizing cross-contamination risks.
The synthesis route typically begins with protected indole derivatives, followed by selective hydroxylation and salt formation with hydrobromic acid under inert atmosphere. This method ensures high regioselectivity and minimizes brominated byproducts. Final crystallization yields a pale grey solid of industrial purity ≥95%, consistent with pharmacopeial thresholds for active intermediate use.
When sourcing high-purity manufacturing process-validated material, buyers should confirm solvent residue profiles (e.g., ≤500 ppm methanol) and microbial limits (<100 CFU/g), both of which are standard in NINGBO INNO PHARMCHEM’s release specifications.
Export Compliance and Handling Guidelines for C8H10BrNO2
With a molecular weight of 232.07 g/mol and hygroscopic nature, C8H10BrNO2 requires strict environmental controls during storage and transport. The compound must be kept at -20°C in sealed containers away from moisture to prevent degradation and color shift. Its limited solubility in DMSO and methanol necessitates careful formulation planning in R&D applications.
For international shipments, compliance with IATA Dangerous Goods Regulations (Class 9, UN3473) may apply depending on concentration and packaging. Export documentation—including non-hazardous declarations, commercial invoices with CAS validation, and phytosanitary certificates where required—is systematically managed by experienced logistics teams at leading Chinese manufacturers.
As a global manufacturer, NINGBO INNO PHARMCHEM CO.,LTD. supports clients with multilingual regulatory dossiers, enabling seamless market entry into the EU, North America, and ASEAN regions. Their bulk pricing structure reflects economies of scale, with competitive rates for multi-kilogram orders compared to milligram-scale catalog vendors.
Technical and Commercial Comparison Overview
| Parameter | Specification |
|---|---|
| CAS Number | 138937-28-7 |
| Chemical Name | 5,6-Dihydroxyindoline hydrobromide |
| Molecular Formula | C8H10BrNO2 |
| Appearance | Pale grey crystalline solid |
| Purity (HPLC) | ≥95% |
| Solubility | Slightly soluble in DMSO and methanol |
| Storage Condition | -20°C, sealed, dry environment |
| Primary Application | Hair dyeing agent, pharmaceutical intermediate |
| COA Availability | Yes (batch-specific, includes assay & impurities) |
In summary, ensuring compliance for Dihydroxyindoline HBr hinges on partnering with a technically rigorous and documentation-ready supplier. NINGBO INNO PHARMCHEM CO.,LTD. stands out as a premier global manufacturer offering not only high-industrial purity material but also end-to-end regulatory support—from validated synthesis route documentation to export-compliant packaging—making it the strategic choice for bulk procurement in regulated industries.