Qualifying a berberine HCl supplier for a US metabolic capsule line

客户面临的问题

A US supplement brand was relaunching a metabolic-wellness capsule and had been burned before by a berberine lot where the certificate of analysis read clean but the label-claim math did not. Their two requirements: an assay they could tie directly to their finished-product label claim, and a heavy-metal and identity panel that would survive their own third-party retest.

技术要求

An HPLC assay reported on a basis the brand could tie directly to its finished-product label claim — with the berberine HCl salt vs berberine cation basis, hydration state and controlled protoberberine alkaloids all fixed in writing — plus an identity and heavy-metal panel that would pass the brand's own third-party retest.

GreeneryBio 的方案

We started from the specification rather than the price. Before any bulk discussion we aligned on whether the HPLC assay was reported on the berberine HCl salt basis or the berberine cation basis, documented the hydration state, and agreed which co-occurring protoberberine alkaloids would be controlled. A 1 kg qualification quantity let their lab run identity, assay and heavy-metal testing against our COA.

配方要点

Capsule fill is straightforward for berberine HCl; the real work was upstream on the specification. We flagged the salt-vs-cation basis and hydration up front so the brand's per-capsule label claim was built on the same number the COA reports.

提供的文件

• Batch-specific COA stating the assay basis, identity and heavy-metal results

成果

The qualification batch cleared the brand's own third-party identity and heavy-metal retest, and the assay basis matched their label-claim method without a conversion surprise. The account moved from sample to first bulk purchase order without a separate re-qualification step, and now runs on standing monthly orders with a quercetin co-supply for an adjacent SKU.

• Cleared the brand's own third-party identity and heavy-metal retest on the first qualification batch
• Aligned the COA assay basis (HCl salt vs berberine cation) with the customer's label-claim method before scale-up
• Established a 1 kg sample-to-bulk path with no separate re-qualification step