Specialty Chemicals

Product Overview

 

 

High-Purity Anhydrous Isopropanol (CAS 67-63-0) is manufactured via catalytic hydration of propylene followed by multi-stage extractive and fractional distillation. Delivered at a minimum assay of 99.9%, this grade features an ultra-low moisture content (<= 0.01%) and strict control over trace volatile organic compounds. It functions as an active solvent, extraction medium, and chemical intermediate for regulated pharmaceutical and electronic production environments.
Production occurs in a closed-loop, continuous-flow distillation facility operating under ISO 9001 and current Good Manufacturing Practice (cGMP) guidelines. Each production lot undergoes gas chromatography (GC-FID) and Karl Fischer titration prior to release, preventing batch variability downstream.

 

 
 
Diethylene Glycol Dimethyl Ether

 

Chemical & Physical Properties

Molecular Formula: C3H8O
Molecular Weight: 60.10 g/mol
Boiling Point: 82.5 deg C at 760 mmHg
Melting Point: -88.5 deg C
Flash Point: 12 deg C (Closed Cup)
Refractive Index (nD20): 1.377 - 1.378
Solubility: Miscible with water, ethanol, ether, and chloroform in all proportions at 20 deg C.

 

Product Specifications

 

 

Parameter

Standard Specification

Test Method

Assay (Purity)

>= 99.9% (wt/wt)

ASTM D2804 / GC-FID

Water Content

<= 0.01% (100 ppm)

ASTM E1064 / Karl Fischer

Density (20 deg C)

0.785 - 0.786 g/cm3

ASTM D4052

Residue on Evaporation

<= 0.001% (10 ppm)

ASTM D1353

Acidity (as Acetic Acid)

<= 0.001%

ASTM D1613

Color (Platinum-Cobalt)

<= 5

ASTM D1209

 

 
 
Applications
01.

Pharmaceutical Synthesis:

Acts as an inert reaction solvent for nucleophilic substitutions and hydrogenation reactions; serves as a recrystallization medium for active pharmaceutical ingredients (APIs).

02.

API Extraction & Washing:

Utilized in the isolation and purification stages of antibiotic and steroid manufacturing where low residual solvent thresholds are mandated.

03.

Electronics Cleaning:

Deploys as a residue-free rinsing agent for semiconductor wafer fabrication lines and printed circuit board assemblies (PCBA) to eliminate ionic contamination.

04.

Chemical Intermediates:

Functions as a precursor in the production of isopropyl acetate, isopropylamine, and various isopropyl esters.

 

 

Pharmaceutical Manufacturing Relevance

Manufactured in alignment with ICH Q7 guidelines for active pharmaceutical ingredients and excipients. Trace impurity profiles are maintained below strict safety thresholds, ensuring negligible interaction with sensitive biochemical pathways during synthesis. The manufacturing process utilizes dedicated stainless steel infrastructure to eliminate cross-contamination from aromatic hydrocarbons or plasticizers. Complete supply chain transparency enables direct integration into customer drug master file (DMF) submissions and regulatory audits.

Dimethyl Sulfoxide (DMSO)

 

Grade & Quality Requirements
 

Grade Availability:

ACS/Reagent Grade, Electronic Grade (VLSI), and Pharmaceutical Grade (USP/EP compliant).

Regulatory Status:

REACH registered (EU), FDA registered facility, Kosher and Halal certified manufacturing assets.

Traceability:

Full forward and backward lot traceability maintained from propylene feedstock sourcing to final container filling.

 

N-Isopropylhydroxylamine

Quality Control

 

Analytical validation is performed on every production batch using calibrated instrumentation.
Gas Chromatography (GC-FID): Quantifies primary assay and isolates secondary alcohols, acetone, and heavy organic impurities down to 1 ppm resolution.
Karl Fischer Coulometric Titration: Measures exact water content to prevent hydrolysis side-reactions in moisture-sensitive formulations.
Non-Volatile Residue (NVR) Analysis: Gravimetric determination ensures zero particulate or inorganic salt carryover after complete evaporation.

Technical Documents

 

COA (Certificate of Analysis): Representative batch COAs detailing actual GC assay, moisture ppm, and density metrics are supplied prior to shipment. Access batch-specific archives via the secure client portal.
SDS (Safety Data Sheet): Compliant with GHS standards (OSHA Hazard Communication Standard 29 CFR 1910.1200 and EU Regulation 1907/2006). Covers physical hazards, personal protective equipment (PPE) requirements, and spill response protocols.
TDS (Technical Data Sheet): Comprehensive technical sheet containing handling parameters, storage stability limits, and packaging configurations.

Ethylene Urea

 

 

Packaging & Storage

 

 

Packaging Options:
Internally polymer-lined carbon steel drums (Net Weight: 160 kg)
High-density polyethylene (HDPE) drums (Net Weight: 160 kg)
UN-certified intermediate bulk containers (IBC / Tote) (Net Weight: 800 kg)
Dedicated ISO tank containers for bulk deliveries (20 - 25 MT)

Hazardous Materials Classification:

UN 1219, Class 3 (Flammable Liquid), Packing Group II. Transported in compliance with international dangerous goods regulations (IMDG, IATA, ADR).

Storage Conditions:

Store in a cool, dry, well-ventilated area away from ignition sources, oxidizers, and direct sunlight. Maintain storage temperatures below 30 deg C.

Shelf Life:

24 months from the date of manufacture when stored in unopened, original containers under recommended environmental conditions.

 

 

Supply & Procurement

 

 

 
MOQ (Minimum Order Quantity):

1 Pallet (4 x 160 kg drums / 640 kg) for drum shipments; 1 ISO Tank (20 MT) for bulk liquid deliveries.

 
Sample Policy:

500 mL analytical samples available for laboratory testing and qualification upon formal request and verification of corporate end-use.

 
Lead Time:

Ex-stock standard inventory: Dispatch within 3 to 5 business days.
Scheduled contract manufacturing runs: 15 to 25 business days.

 
Bulk Supply Capabilities:

Annual volume commitments supported via fixed-price framework agreements, multi-port dispatch logistics, full export documentation support (Certificate of Origin, Custom Clearance dossiers), and vendor-managed inventory (VMI) programs.

 

 

OEM / Custom Specification

Custom Purities:

Capability to tailor maximum moisture limits down to <= 0.005% (50 ppm) or restrict specific volatile organic impurities based on proprietary client requirements.

Custom Labeling:

Private label packaging, customized lot numbering formats, barcoding (GS1-128), and client-specific shipping mark applications available for long-term supply contracts.

 

FAQ

 

 

Q: Is this product certified for use in parenteral drug manufacturing?

A: Yes. It meets or exceeds USP and EP monograph specifications and is produced under cGMP standards suitable for downstream pharmaceutical processing.

Q: Can you provide third-party audit reports?

A: Yes. ISO 9001 and cGMP audit summaries or direct facility audits can be scheduled through our quality assurance department for qualified contract buyers.

Q: What is the procedure for managing seasonal demand fluctuations under an annual contract?

A: Annual contracts include rolling 6-month forecast schedules, allowing call-off orders with guaranteed volume allocations secured in our regional distribution hubs.

 

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