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Pharmaceutical API Purification
Process Purification & Recovery

Pharmaceutical API Purification

USP and EP grade powdered activated carbon for active pharmaceutical ingredient (API) purification by slurry contact, removing colour bodies, residual catalysts, and trace impurities ahead of final crystallisation.

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The Challenge
API synthesis generates colour bodies (from thermal stress, oxidation, and side reactions), residual metal catalysts (palladium, platinum, rhodium), and trace organic impurities that must be removed before the final crystallisation to meet the API specification. PAC slurry treatment is the standard purification route.
Quick Answer

Pharmaceutical API purification uses USP and EP grade powdered activated carbon dosed into the contact reactor to remove colour bodies, residual catalysts, and trace impurities from active pharmaceutical ingredient process streams. Carbon is filtered out with a sterile or guard filter ahead of final crystallisation. Change control documentation supports the GMP regime.

Pharmaceutical API Purification

API Purification Is GMP Critical

Active pharmaceutical ingredient (API) production requires the most demanding purification regime of any SorbiTech application. The final API must meet the product monograph specification on colour, residual solvent, residual catalyst, related substances, and impurity profile. PAC slurry treatment at the late stage of synthesis is the standard purification route, removing the colour bodies, residual transition metal catalysts, and trace organic impurities that the upstream synthesis steps did not address.

USP and EP Grade PAC Specification

The carbon must meet the USP or EP monograph for activated carbon: heavy metals below the regulated limits, ash below 6 percent, moisture below 10 percent, and the decolorization performance against the standard reference. SorbiTech USP/EP grade PAC meets these limits with full COA per lot and the change control documentation that the GMP regime requires.

Pharmaceutical API Purification process equipment

Process Integration

The PAC is dosed into the contact reactor at the contracted stage of the synthesis (typically just before the final crystallisation). The slurry is mixed at the working temperature for the contracted residence time (typically 30 to 60 minutes), then filtered through a 0.2 micron sterile filter or a guard filter ahead of the next process step. The spent carbon is collected with the filter cake and disposed of as pharmaceutical waste under the regional regulation.

Documentation and Change Control

Every shipment carries the certificate of analysis, the material safety data sheet, the traceability from raw material lot, and the change control notifications for any specification or process modification. The SorbiTech manufacturing facility supports FDA and EMA audits with the operator at the manufacturing site on request. Sector coverage is pharmaceutical and life sciences.

Selection Guidance

USP/EP grade PAC at 0.2 to 1 percent dose. Laboratory decolorization and impurity removal test against the actual API stream. Sterile or guard filter downstream. Full change control documentation.

How SorbiTech Solves It

A Specified, Verified Solution

Define the duty

We capture your process conditions: flow, composition, pressure, temperature, and the target outlet specification.

Select media & configuration

Our engineers recommend the adsorbent grade and system type that meet the duty with margin.

Size & engineer

Bed sizing, vessel design, and cycle parameters are engineered to your case and documented for approval.

Commission & verify

We support loading, start up, and performance verification against the guarantee.

Recommended Products & Systems

Media

Adsorbents & Media

  1. 01 Powdered Activated Carbon Adsorbent Powdered Activated Carbon Fine powder carbon for slurry dosing in water treatment, sugar decolorization, pharmaceutical purification, and emergency contamination response. Form 200×325 mesh (45–75 µm)
  2. 02 CMS 450hp Adsorbent Carbon Molecular Sieve CMS 450HP Ultra high purity carbon molecular sieve. 99.99999 percent (7N) N2, selective O2 and CO2 capture, 1.0 to 1.6 mm pellets, minimal fines, deoxo polishing… Water Cap. Feed must reach ISO 8573 class 1.4.1, deoxo polishing recommended for 7N %
  3. 03 SorbiTech Impregnated Activated Carbon H2S Acid Gas Mercury Removal Adsorbent Impregnated Activated Carbon Sulfur, KI, or KOH impregnated activated carbon. Mercury below 10 ng per Nm3, H2S and mercaptan capture upstream of catalysts. 4 mm pellet or… Water Cap. Dry feed preferred, water displaces impregnant %
  4. 04 SorbiTech Orapure Activated Carbon Coconut Shell Gold Recovery Cip Cil Adsorbent OraPure Activated Carbon Coconut shell granular activated carbon for gold recovery. 6x12, 6x16, 8x16 mesh, iodine number above 1000 mg/g, optimised pore for high K value, thermal… Water Cap. Low moisture and ash at supply %
  5. 05 Pellet Activated Carbon Adsorbent Pellet Activated Carbon Extruded pellet carbon for gas phase duties: solvent recovery, vapour recovery, odour control, and mercury guard beds. Form 3 mm or 4 mm extruded pellets
  6. 06 Molecular Sieve 5a Adsorbent Molecular Sieve 5A Calcium form 5A zeolite for n paraffin separation, hydrogen purification, and oxygen PSA generation. Pore Ø 5 Å
Equipment

Engineered Systems

  1. 01 SorbiTech Cip Cil Gold Carbon Plant Carbon in Pulp Leach Gold Recovery Equipment CIP CIL Gold Carbon Plant Carbon in pulp (CIP) and carbon in leach (CIL) gold recovery plant using high activity coconut shell granular activated carbon to recover gold cyanide… Capacity 10–200 t/h ore throughput
  2. 02 SorbiTech Biogas Upgrading Unit Biomethane PSA Carbon Molecular Sieve Equipment Biogas Upgrading Unit PSA biogas upgrading unit using carbon molecular sieve to separate carbon dioxide from methane and deliver grid quality bio methane from anaerobic digester biogas… Capacity 50–2,000 Nm³/h raw biogas
  3. 03 SorbiTech Activated Carbon Water Contactor Drinking Water GAC Polishing Contactor Equipment Activated Carbon Water Contactor Granular activated carbon fixed bed water contactor for dechlorination, taste and odour, dissolved organic carbon, and emerging contaminant polishing in drinking water and process… Capacity 5–2,000 m³/h
  4. 04 SorbiTech Vapour Recovery Unit Activated Carbon VRU Solvent Recovery Equipment Vapour Recovery Unit (VRU) Activated carbon vapour recovery unit for tank farms, loading racks, and process vents to capture and recover hydrocarbons before stack release. Capacity 50–10,000 Nm³/h vent gas
Industries

Industries Using This Application

  1. 01 SorbiTech Pharmaceutical Life Sciences Gmp Biotech Campus Manufacturing Facility Sector Pharmaceutical & Life Sciences USP and EP grade adsorbent media for API purification, GMP compliant nitrogen generation, and controlled humidity packaging desiccants for the pharmaceutical sector.

Specify a Solution for This Application

Provide your process conditions and our team will recommend the grade, configuration, and sizing.

contact@sorbitech.com