Excipient Checks (Substance Level)
FDA IID (FDA Inactive Ingredient Database)
The FDA maintains a list of all inactive ingredients (excipients) that have been used in approved drug products in the United States. If an excipient appears in this database, it means the FDA has already accepted it in at least one approved medication for a specific route (e.g., oral, topical). The database also records the maximum concentration at which the excipient has been approved for each dosage form.
USP-NF (United States Pharmacopeia / National Formulary)
The USP-NF is the official compendium of quality standards for pharmaceutical ingredients in the United States. If an excipient has a USP-NF monograph, it means there are published, legally recognized specifications for its identity, purity, and testing methods. Regulatory agencies expect pharmaceutical-grade excipients to comply with these monograph standards.
GRAS (Generally Recognized As Safe)
GRAS is an FDA designation meaning that a substance is considered safe for use in food based on a long history of use or scientific evidence. The check covers three sub-sources: CFR listings (substances codified in federal regulations), SCOGS reports (historical safety reviews from the 1970s-1980s), and GRAS Notices (voluntary notifications submitted by manufacturers since 1998). A GRAS listing can support the safety justification for an excipient, especially when it is also used as a food ingredient.
Ph. Eur. (European Pharmacopoeia)
The European Pharmacopoeia is the official quality standards reference for pharmaceutical ingredients across Europe, maintained by the EDQM in Strasbourg. If an excipient has a Ph. Eur. monograph, it means European regulators have defined binding specifications for its quality, identity, and purity. Compliance with the relevant Ph. Eur. monograph is a requirement for marketing authorization applications in the EU and many other countries that recognize it.
EINECS (European Inventory of Existing Commercial Chemical Substances)
EINECS is the EU registry of all chemical substances that were commercially available in the European Community before September 1981. An EINECS number confirms that the substance is a recognized, registered chemical entity within the EU regulatory framework. Substances without an EINECS entry (such as polymers or novel chemicals) may require additional registration under REACH.
E-Numbers (EU Food Additive Codes)
E-Numbers are codes assigned by the European Union to substances approved for use as food additives. If an excipient has an E-Number, it confirms that EU authorities have evaluated and approved it for food use, which can support its safety profile in pharmaceutical applications. The check also flags restrictions or special conditions, such as the E171 (titanium dioxide) ban as a food additive with a pharma exemption still in place.
JP (Japanese Pharmacopoeia)
The Japanese Pharmacopoeia is the official compendium of pharmaceutical quality standards in Japan, published by the PMDA. A JP monograph confirms that the excipient is recognized and has defined quality specifications for use in pharmaceutical products marketed in Japan. Compliance is required for drug registration with Japanese regulatory authorities.
ChP (Chinese Pharmacopoeia)
The Chinese Pharmacopoeia is the official reference for pharmaceutical quality standards in China, published by the NMPA. A ChP monograph confirms that the excipient has been evaluated and has defined specifications for the Chinese market. Pharmaceutical products intended for registration in China must use excipients that comply with ChP standards.
IP (Indian Pharmacopoeia)
The Indian Pharmacopoeia is the official compendium of pharmaceutical quality standards in India, published under the authority of the CDSCO. An IP monograph confirms that the excipient is recognized and has established specifications for identity, purity, and quality testing. Compliance is required for pharmaceutical products registered and sold in the Indian market.
Supplier Checks (Documentation Level)
DMF Type IV (Drug Master File, Type IV)
A Drug Master File is a confidential document submitted to the FDA by a manufacturer containing detailed information about the manufacturing process, quality controls, and specifications of an excipient. Type IV specifically covers excipient manufacturing. An active DMF on file means the FDA can reference the supplier's documentation when reviewing drug applications that use their excipient, which streamlines the approval process for the drug manufacturer.
CEP (Certificate of Suitability to the European Pharmacopoeia)
A CEP is a certificate issued by the EDQM confirming that a specific manufacturer's production process and quality controls meet the requirements of the relevant European Pharmacopoeia monograph. It provides European regulators with documented proof that the excipient from that particular supplier is produced to the required standard. A valid CEP simplifies the EU marketing authorization process because applicants can reference the certificate instead of disclosing the full manufacturing details.
ExciPact GMP/GDP Certification
ExciPact is an independent, industry-led certification scheme that audits excipient manufacturers against Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) standards. A valid ExciPact certificate confirms that the supplier's production or distribution facilities have been independently inspected and meet internationally recognized quality standards for pharmaceutical excipients. While not legally required, ExciPact certification is increasingly expected by regulators and customers as evidence of supply chain quality assurance.
Special Flags
TSE/BSE Risk Flag
TSE (Transmissible Spongiform Encephalopathy) and BSE (Bovine Spongiform Encephalopathy, commonly known as "mad cow disease") are fatal brain diseases that can theoretically be transmitted through materials derived from infected animals. This flag identifies excipients that are of animal origin or may be of animal origin depending on the supplier's source material, and indicates whether TSE/BSE risk documentation is required for regulatory submissions. The flag covers 35 excipients across three categories: always required (e.g., gelatin, lactose), source dependent (e.g., stearic acid, glycerin, which can be animal or vegetable), and documentation recommended (e.g., shellac, from insects, where TSE does not apply but animal origin should be declared).
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