Refined N-RBD Shea Butter for Pharmaceutical Excipient Use

Recommended specifications for pharmaceutical excipient

For excipient use, free fatty acid, peroxide value and moisture decide purity; residual-solvent and process-aid statements decide qualification — this is not a finished-drug specification. The signed specification agreement is the reference if no monograph exists (see pharmaceutical buyers). How to read the sheet is in the COA guide. Test methods are listed in the test-methods directory.

Why Refined N-RBD shea butter suits pharmaceutical excipient

• N-RBD is what produces the low free-fatty-acid, peroxide-value and moisture ceiling a topical quality system will write.
• Extraction is mechanical; no hexane is used. Residual-solvent rows appear only when a tested statement exists.
• N-RBD process aids are neutralisation alkali or physical refining, bleaching earth and vacuum steam. EMI reports what it tests; untested aids are omitted.
• The signed specification agreement is the reference if no pharmacopoeial monograph exists. Qualification language and the document pack live on the pharmaceutical-buyers page.
• This is an excipient fat, not a finished medicinal product. The marketing authorisation holder owns the drug product.
• No Ph. Eur. or USP monograph compliance is claimed. Food-grade paperwork is not the same as excipient-use paperwork.

Write the specification agreement as identity, purity and residuals — then match every incoming lot to that agreement, not to a brochure. Change control and audit questions belong on pharmaceutical buyers. The recommended specification is in the table above. What N-RBD uses as process aids is in the refining guide. Food-grade paperwork is not excipient-use paperwork; food law lives on refined N-RBD for food manufacturing. Cosmetic colour and odour performance lives on refined N-RBD for cosmetics.

Qualification checklist:

• COA versus the signed agreement;
• residual-solvent or process-aid letter, if issued;
• SDS, if issued;
• retain sample and an incoming identity check against the test methods.

This is an excipient fat, not a finished drug. This page does not claim GMP certification, pharmacopoeia-grade status, or any indication or treatment.

Why unrefined Grade A is not offered for this use

Unrefined Grade A is not offered as an excipient: higher free fatty acid and peroxide value, odour, colour and fewer residual controls sit outside a topical purity specification. Cosmetic performance lives on the refined cosmetics page. Food law lives on the food-manufacturing page. Buyer qualification lives on the pharmaceutical-buyers page. unrefined Grade A shea butter.

Supply format

EMI Agro loads at Apapa (Lagos) and Tin Can Island (Lagos). Packaging, sample size, minimum order, Incoterms and lead time are confirmed on the quote for the grade and destination you name.

Quality & traceability

Finished butter is specified on a NIS 571:2013 basis. Parameters in the table are measured on every finished batch; the Certificate of Analysis reports the measured values. Kernel lots are titrated for free fatty acid at intake and kept segregated. Kernels are wild-collected through a cooperative network of 5,000+ women collectors. Certification status: NAFDAC registered, SON approved, HACCP in progress, USDA NOP (Organic) in pursuit, EU Organic (EOS) in pursuit, COSMOS in pursuit. Detail sits on the quality page.

• Every finished batch is tested; measured values are reported on the Certificate of Analysis.
• Kernel lots are titrated for free fatty acid at intake and kept segregated.