| 1 | Applicable Pharmacopoeial Compliance | Conformity should be demonstrated against the applicable current pharmacopoeial monograph, such as USP–NF, Ph. Eur., BP, or another recognized standard. | “Pharmaceutical grade” is not one universal specification; requirements depend on the intended use and market. | Current certificate of analysis, monograph testing, and regulatory documentation review. |
| 2 | Raw Material Source | Common carbonaceous precursors include coconut shell, wood, peat, and coal; the precursor should be declared and controlled for each batch. | The precursor affects pore structure, ash content, adsorption behavior, and potential contaminants. | Supplier questionnaire, traceability records, incoming-material testing, and risk assessment. |
| 3 | Iodine Number | Many commercial activated carbons are specified within an approximate range of 700–1,200 mg/g, although the required value depends on the application and approved specification. | It is an indicator of micropore development and adsorption capacity for relatively small molecules. | Iodometric titration using a recognized activated-carbon test method, such as ASTM D4607. |
| 4 | Methylene Blue Adsorption | A commonly reported commercial range is approximately 150–300 mg/g; the target should be established for the specific product and use. | It provides information about adsorption of larger molecules and mesopore accessibility. | Validated methylene blue adsorption test with a defined sample preparation procedure. |
| 5 | Moisture and Loss on Drying | Powdered activated carbon commonly has moisture controlled around or below 5–10%, depending on the product specification and test conditions. | Excess moisture can affect net active content, flowability, storage stability, and adsorption performance. | Gravimetric loss-on-drying test at a specified temperature and drying time. |
| 6 | Total Ash and Inorganic Residue | Pharmaceutical applications generally require controlled ash and inorganic residue; exact limits must follow the approved monograph or product specification. | High ash may reduce adsorption capacity and introduce undesirable inorganic substances. | Ignition or ashing test followed by gravimetric determination. |
| 7 | Heavy Metals and Elemental Impurities | Elemental impurities should comply with the applicable risk-based limits, commonly assessed under ICH Q3D and relevant regional requirements. | Carbon materials can contain trace levels of lead, arsenic, cadmium, mercury, and other elements depending on their source. | ICP-MS, ICP-OES, or another validated elemental-analysis technique. |
| 8 | Particle Size and Physical Form | Available forms include powder, granules, and molded products; particle-size distribution should match the intended dosage or processing method. | Particle size influences dispersion, filtration, handling, dissolution behavior, and adsorption kinetics. | Sieve analysis, laser diffraction, or another validated particle-size method. |
| 9 | Microbiological Quality | Total aerobic microbial count, total yeast and mold count, and specified microorganisms should meet the limits established for the intended pharmaceutical use. | Activated carbon is a porous material that can retain moisture and environmental contaminants if not properly controlled. | Pharmacopoeial microbial enumeration and specified-microorganism tests. |
| 10 | Quality System, Packaging, and Traceability | A suitable supplier should provide batch traceability, change control, deviation management, tamper-evident packaging, and storage conditions that protect the material from moisture and contamination. | Consistent documentation and controlled handling are essential for pharmaceutical supply-chain qualification. | GMP audit, quality agreement, batch records, certificates of analysis, and packaging inspection. |