Contract-made prenatal softgels pairing DHA with folic acid or L-5-MTHF, in a marine fish-oil build or a fish-free vegan algal build. Allergen and diet status declared per build; 200 mg DHA is the usual base.
| Dosage form | Oval oil-fill softgel, 500 mg or 1000 mg fill. Shell in bovine gelatin, fish gelatin, or a vegetarian starch and glycerin system, per the build ordered. |
| DHA source options | Marine build: refined fish body oil or omega-3 concentrate (Engraulis ringens, Sardinops sagax, Scomber spp.). Vegan build: Schizochytrium sp. microalgal oil. |
| DHA identity | Docosahexaenoic acid, CAS 6217-54-5, C22H32O2, 328.5 g/mol; (4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenoic acid. Triglyceride form standard. |
| DHA loading basis | 200 mg DHA per daily dose is the usual base; the EU maternal labelling condition of use is 200 mg DHA on top of the 250 mg DHA plus EPA adult intake. |
| Folate source | Folic acid, CAS 59-30-3, C19H19N7O6, 441.4 g/mol; or levomefolate calcium (L-5-MTHF calcium), CAS 151533-22-1, C20H23CaN7O6, 497.5 g/mol. |
| Folate loading and ceiling | Typically 400–800 µg. EFSA sets a folate UL of 1000 µg/day for adults and in pregnancy, covering added folic acid and 5-MTHF salts but not food folate. |
| EU reference value | Folic acid NRV 200 µg under Reg. (EU) No 1169/2011, Annex XIII; per cent NRV must appear on EU labels. EFSA has derived no UL for DHA, EPA or DPA. |
| Oil oxidation limits | GOED voluntary monograph: peroxide value NMT 5 meq/kg, p-anisidine NMT 20, TOTOX NMT 26. Acid value NMT 0.5 mg KOH/g on the algal oil build. |
| Marine contaminants | Fish-oil builds tested to Reg. (EU) 2023/915: dioxins NMT 1.75 pg WHO-TEQ/g fat, dioxins plus dl-PCBs NMT 6.0, ICES-6 NDL-PCBs NMT 200 ng/g fat. |
| Allergen — marine build | Contains FISH. Annex II item 4 of Reg. (EU) No 1169/2011 exempts only fish gelatine used as a vitamin carrier, so refined fish oil is still declarable. |
| Allergen — algal build | Free of fish, crustacean, milk, egg, gluten, peanut and tree nut. Soy declarable only where soy-derived tocopherol is used; sunflower tocopherol avoids it. |
| Diet and origin status | Marine build is animal origin and not vegetarian. Algal oil in a starch and glycerin shell is vegan; a bovine or fish gelatin shell removes that status. |
| Stabilisation and testing | Mixed tocopherols with ascorbyl palmitate or rosemary extract. Release testing: DHA by GC, folate by HPLC, fill weight, seal integrity, heavy metals, microbiology. |
| Shelf life, storage | 24 months at 15–30 °C, dark, nitrogen-flushed headspace. Alu-Alu blister or HDPE bottle with desiccant. |
| HS code | 21069099 |
Marine build on standard 18/12 fish body oil or on higher DHA concentrates; Ph. Eur. 1912 pharmacopoeial oil where the buyer's monograph reference requires it. Vegan build on Schizochytrium sp. microalgal oil, DHA at or above 32 per cent of total fatty acids, in a starch and glycerin shell. Folate as folic acid to IP/BP/USP, or as levomefolate calcium. Fill sizes 500 mg and 1000 mg; shell in bovine gelatin, fish gelatin or vegetarian. Halal, kosher, MarinTrust or Friend of the Sea chain of custody and non-GMO documentation on request, subject to lot availability.
Shatavari (Asparagus racemosus) women's tonic in powder or syrup form, standardised on total steroidal saponins to the buyer's figure. Vegan, milk-free export build; dairy versions declared.
Cranberry extract standardised on proanthocyanidins by DMAC (AOAC 2019.06) blended with D-mannose in one capsule. Vegan HPMC shell, peanut-free cranberry verified per lot, private label to order.
Soft gelatin capsules filled with Oenothera biennis seed oil standardised to 9-10% gamma-linolenic acid. Bovine gelatin, fish gelatin or vegan HPMC shell, 500 mg and 1,000 mg fills, private label from India.