Pharmaceutical Active Ingredient Extraction & Recrystallisation
Chemical application profile

Pharmaceutical Active Ingredient Extraction & Recrystallisation

Selective liquid-liquid extraction, botanical alkaloid partitioning, and solvent recrystallisation of active pharmaceutical ingredients (APIs).

Target SectorsPharmaceutical Raw Materials & Excipients Supplier Kenya · Chemical Manufacturing & Toll Blending Raw Materials Kenya
Packaging25kg Bags · 200L Drums · IBC Tankers · Bulk Delivery
DocumentationBatch COA, TDS & SDS Available on Request

Quick Answer — Pharmaceutical Active Ingredient Extraction & Recrystallisation

High-purity Ethyl Acetate 99.8% Min serves as an ICH Class 3 low-toxicity solvent for pharmaceutical liquid-liquid extraction and API recrystallisation, separating organic actives from aqueous broths and evaporating cleanly below 45°C under vacuum.

Pharmaceutical active ingredient extraction is the selective dissolution and isolation of therapeutic chemical compounds from biological or synthetic media using organic solvents.

Key Facts

  • •Classified under ICH Q3C as a Class 3 low-toxicity pharmaceutical solvent.
  • •Low boiling point (77°C) allows vacuum evaporation below 45°C.
  • •Formulates high-purity crystalline APIs with low non-volatile residues.
  • •Supplied in factory-sealed 180 kg steel drums by KIKI'S Industrial Chemicals.

Primary Use Cases

Botanical and herbal pharmaceutical active extractionAntibiotic and synthetic intermediate recrystallisationAnalytical laboratory HPLC washing and extraction

Technical Process

In pharmaceutical processing and botanical extraction, ethyl acetate is utilized across both liquid-liquid partitioning and recrystallisation:

Liquid-Liquid Partitioning from Aqueous Broths

Aqueous fermentation broths or plant digests are mixed with Ethyl Acetate 99.8% in counter-current centrifugal extractors or jacketed separation columns. Because ethyl acetate forms a distinct separate phase (water solubility ~8.3%), target active organic molecules partition selectively into the upper organic ester phase, leaving polar impurities, sugars, and inorganic salts in the water phase.

Low-Temperature Vacuum Distillation and Solvent Recovery

The rich extract is pumped into rotary vacuum evaporators. Boiling at a low 77°C at atmospheric pressure (and under 40°C under modest vacuum), ethyl acetate evaporates cleanly without exposing heat-sensitive APIs to thermal degradation. Recovered solvent is condensed at >98% efficiency for closed-loop re-use.

Recrystallisation and Residual Solvent Compliance

Crude API crystals are dissolved in hot ethyl acetate and cooled slowly under controlled seeding. Pure crystals precipitate out with high enantiomeric and chemical purity. Classified under ICH Q3C as a Class 3 solvent (solvents with low toxic potential), international pharmacopeias allow up to 5,000 ppm residual ethyl acetate in finished pharmaceutical products.

KIKI'S Industrial Chemicals supplies virgin Ethyl Acetate 99.8% Min with certified non-volatile residues <20 ppm, ideal for pharmaceutical and phytochemical processing.

Standard Application Process

  1. 1

    Liquid-Liquid Immiscible Partitioning

    Agitate aqueous botanical digest or fermentation broth with Ethyl Acetate; separate phases cleanly.

  2. 2

    Low-Temperature Vacuum Evaporation

    Strip ethyl acetate under vacuum below 45°C to concentrate the API without thermal degradation.

  3. 3

    Cooling Recrystallisation & Filtration

    Dissolve concentrated API in hot ethyl acetate; cool slowly to yield high-purity pharmaceutical crystals.

Recommended Chemicals for Pharmaceutical Active Ingredient Extraction & Recrystallisation

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Industrial Solvents
200kg steel drum of Ethyl Acetate 99.8% Min supplied by KIKI'S Industrial Chemicals Nairobi Kenya

Ethyl Acetate 99.8% Min Pure (Fast-Evaporating Ester Solvent)

High-purity Ethyl Acetate 99.8% min (CAS 141-78-6, UN 1173) supplied in 200kg steel drums and IBCs by KIKI'S Industrial…

Used for: Flexible Packaging Rotogravure & Flexographic Ink Solvation · Polyurethane & Neoprene Contact Adhesive Compounding · Pharmaceutical Active Ingredient Extraction & Recrystallisation
200kg Steel Drum (Epoxy-Phenolic Lined)1000L / 890kg UN-Approved Composite IBC

CAS 141-78-6 · Industrial Pure Grade · Liquid

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Key Performance Advantages

  • ✓
    ICH Q3C Class 3 Low Toxicity Rating

    Permits generous pharmaceutical residual solvent limits up to 5,000 ppm without safety concerns.

  • ✓
    Low Boiling Point Protects Heat-Sensitive APIs

    Evaporates completely below 45°C under vacuum, preventing thermal degradation of delicate bio-molecules.

  • ✓
    High Partition Selectivity

    Selectively extracts non-polar to moderately polar organic compounds away from aqueous impurities.

Key Industrial Use Cases

Natural pyrethrum, artemisinin, and botanical extract refining in KenyaPenicillin and cephalosporin antibiotic crystallizationPharmaceutical intermediate washing and reaction solvent mediaActive steroid and hormone extraction from biological cultures

COMMERCIAL & TECHNICAL GUIDANCE

FAQs — Pharmaceutical Active Ingredient Extraction & Recrystallisation

Technical and process guidance for pharmaceutical active ingredient extraction & recrystallisation in Kenya and East Africa.

DCM is a toxic chlorinated solvent (ICH Class 2) with potential carcinogenicity. Ethyl Acetate is an ICH Class 3 solvent with low toxicity, higher environmental acceptance, and safer handling.