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?
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 | USP / EP |
| 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) |
| Pharmacopoeial Grade | BP (British Pharmacopoeia), USP (United States Pharmacopeia), EP (European Pharmacopoeia), IP (Indian Pharmacopoeia) |
| Pharmacopoeial Grade | BP (British Pharmacopoeia), USP (United States Pharmacopeia), EP (European Pharmacopoeia), IP (Indian Pharmacopoeia) |
| Application Grade | Injectable / Parenteral grade API — oil-in-water emulsion formulation |
Manufacturing & 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
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
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.
Frequently Asked Questions
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