Propofol API Manufacturer & Exporter
WHO-GMP certified injectable-grade Propofol API - oil-in-water emulsion grade, BP/USP/EP/IP compliant, bulk supply with full regulatory documentation
Looking for a reliable supplier of Propofol API?
DK Pharmachem is a WHO-GMP certified Propofol API manufacturer in India, supplying injectable-grade Propofol (CAS 2078-54-8) to pharmaceutical emulsion manufacturers, hospital pharmacy suppliers, and anaesthesia drug producers across regulated and emerging markets worldwide. Propofol (2,6-diisopropylphenol) is a highly lipophilic oily liquid at ambient temperature, formulated exclusively as a sterile oil-in-water (o/w) emulsion for intravenous delivery — making the purity, consistency, and emulsification compatibility of the API critical to the safety and stability of the finished injectable product.
Our facility in Badlapur, Maharashtra produces Propofol API conforming to BP, USP, EP, and IP pharmacopoeial standards at ≥99% purity, with stringent control of related substances, residual solvents, and heavy metals to meet the exacting requirements of parenteral-grade emulsion manufacturing. Full regulatory documentation including Drug Master Files (DMF/EDMF), Certificate of Analysis, and stability data is available to support your market authorisation requirements.
Propofol API Specifications | CAS 2078-54-8
| Attribute | Details |
|---|---|
| Chemical Name | 2,6-Diisopropylphenol |
| Synonyms | Diprivan (brand); 2,6-DIPP; Disoprofol |
| Pharmacopoeia Standard | BP (British Pharmacopoeia), USP (United States Pharmacopeia), EP (European Pharmacopoeia), IP (Indian Pharmacopoeia) |
| CAS Number | 2078-54-8 |
| Molecular Formula | C₁₂H₁₈O |
| Molecular Weight | 178.27 g/mol |
| Therapeutic Application | General Anesthetic |
| DMF / EDMF Status | Available |
| Manufacturing Standard | WHO-GMP Certified |
| Appearance | Clear to pale yellow oily liquid at room temperature (melting point ≈19°C — liquid at ambient temperature) |
| Purity | ≥99.0% (conforming to BP / USP / EP / IP) |
| Application Grade | Injectable / Parenteral grade API — oil-in-water emulsion formulation |
Manufacturing Process & Regulatory Credentials
Propofol API at DK Pharmachem is produced through a controlled alkylation synthesis process at our dedicated facility in Badlapur, Maharashtra. The synthesis of 2,6-diisopropylphenol involves precise Friedel-Crafts alkylation under strictly controlled temperature and catalyst conditions, followed by multi-stage purification including vacuum distillation to achieve the ≥99% purity and controlled impurity profile required for injectable emulsion formulation use. As a liquid API, every production batch undergoes comprehensive release testing including identity confirmation (GC, IR), assay, related substances profile, residual solvents, heavy metals, and appearance — all conducted in our WHO-GMP certified in-house quality control laboratory.
Validated injectable-grade manufacturing infrastructure
Multi-pharmacopoeia compliance from a single source
Proven anaesthetic API supply chain
Cost efficiency without compromising injectable-grade quality
Regulatory filing depth
Indian injectable API manufacturers increasingly hold USDMF, EDMF, and CEP filings for anaesthetic molecules, reducing qualification timelines and regulatory friction for buyers in regulated markets
As one of the established Propofol manufacturers in India, we ensure uninterrupted supply chains and strict adherence to global quality standards.
Pharmaceutical Formulation Applications & Emulsion Manufacturing Use
Propofol API is used exclusively in sterile injectable (parenteral) formulations - specifically as oil-in-water (o/w) emulsions for intravenous administration. The API's near-zero aqueous solubility and high lipophilicity make emulsion formulation the only clinically validated delivery system; the standard commercial formulation contains 1% Propofol, 10% soy bean oil, and 1.2% purified egg lecithin as emulsifier, with glycerol for isotonicity. Pharmaceutical manufacturers sourcing Propofol API require an active ingredient whose physical-chemical properties - lipophilicity, related substance profile, and absence of water-miscible contaminants - are consistent enough to guarantee emulsion stability, particle size distribution, and microbial quality in the finished injectable product.
Key formulation applications for injectable manufacturers sourcing Propofol API from DK Pharmachem include: induction and maintenance of general anaesthesia IV emulsion formulations (1% and 2% Propofol emulsions for bolus and infusion use); ICU sedation emulsion formulations for mechanically ventilated adults; procedural sedation emulsions for diagnostic and interventional procedures; veterinary anaesthesia injectable formulations; and next-generation Propofol formulations including cyclodextrin-based aqueous systems and lipid-free microemulsion approaches for markets where soy/egg allergen-free formulations are required. DK Pharmachem's ≥99% pure Propofol API, with validated residual solvent and related substance profiles, is directly suitable for all of these formulation types.
Request a Quote from India's Leading Propofol Manufacturer
As a Propofol API Manufacturer and Global Exporter, DK Pharmachem supplies Propofol API in its natural liquid state, packaged in amber glass bottles or light-protected HDPE containers with hermetic sealing to prevent light exposure, oxidative degradation, and contamination during transit. Standard pack sizes are 1 kg, 5 kg, and 25 kg; custom bulk configurations are available for high-volume emulsion manufacturers. All packaging is nitrogen-blanketed prior to sealing to maintain inert atmosphere and minimise oxidation of the API during storage and shipping. Temperature-controlled transport (15–25°C) is available for international shipments requiring controlled ambient conditions.
Packaging, Handling & Storage Guidelines
Propofol API is a liquid and is packed to protect it from light, oxidation and contamination throughout the supply chain.
Packaging Options
- Amber glass bottles
- Light-protected HDPE containers with hermetic sealing
- Standard pack sizes of 1 kg, 5 kg and 25 kg
- Custom bulk packaging available for high-volume emulsion manufacturers
- Nitrogen-blanketed before sealing
Handling & Storage
- Store at 15–25°C in a well-ventilated area
- Protect from light and avoid excessive heat or freezing
- Keep containers tightly closed and hermetically sealed
- Follow standard safety precautions during handling
- Shelf life: 24 months from the date of manufacture under recommended storage conditions
Correct storage protects the API's purity and oxidative stability, keeping it suitable for injectable emulsion manufacturing.
Why Choose DK Pharmachem for Propofol API sourcing?
Choosing the right sourcing partner for Propofol means evaluating quality, regulatory standing, supply reliability, and long-term partnership capability. DK Pharmachem has been a trusted name in pharmaceutical APIs for over four decades, built on a foundation of manufacturing excellence and customer trust.
Direct Manufacturer, Not a Trader
WHO-GMP Certified API Manufacturing
EDMF Registration Support
EP/BP Compliant Product Quality
Comprehensive Technical & Export Documentation
Bulk Supply & Long-Term Contract Support
D.K. Pharmachem is trusted by pharmaceutical companies for consistent quality and dependable supply.
Frequently Asked Questions
Who are the leading Propofol API manufacturers in India?
How is Propofol API manufactured?
Propofol (2,6-diisopropylphenol) is produced through a controlled alkylation synthesis, using Friedel-Crafts alkylation under strictly managed temperature and catalyst conditions. The crude product then goes through multi-stage purification, including vacuum distillation, to reach ≥99% purity and a controlled impurity profile suitable for injectable emulsion use. Because Propofol is a liquid API, every batch is released only after testing for identity (GC and IR), assay, related substances, residual solvents, heavy metals, and appearance in a WHO-GMP certified in-house quality control laboratory.
What is Propofol API used for in pharmaceutical manufacturing?
Propofol API (CAS 2078-54-8) is used as the active pharmaceutical ingredient in injectable oil-in-water emulsion formulations for intravenous anaesthesia and ICU sedation. It is the active ingredient in finished dosage forms used for induction and maintenance of general anaesthesia, procedural sedation, and sedation of mechanically ventilated adults in intensive care. The API is supplied to injectable emulsion manufacturers, hospital pharmacy producers, and anaesthesia drug CMOs for sterile emulsion formulation and fill-finish manufacturing.