Prenatal DHA + Folic Acid Softgels

Prenatal DHA + Folic Acid Softgels

Prenatal omega-3 softgel · DHA with folic acid or L-5-MTHF

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.

Specifications

Dosage formOval 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 optionsMarine build: refined fish body oil or omega-3 concentrate (Engraulis ringens, Sardinops sagax, Scomber spp.). Vegan build: Schizochytrium sp. microalgal oil.
DHA identityDocosahexaenoic 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 basis200 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 sourceFolic 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 ceilingTypically 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 valueFolic 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 limitsGOED 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 contaminantsFish-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 buildContains 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 buildFree 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 statusMarine 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 testingMixed tocopherols with ascorbyl palmitate or rosemary extract. Release testing: DHA by GC, folate by HPLC, fill weight, seal integrity, heavy metals, microbiology.
Shelf life, storage24 months at 15–30 °C, dark, nitrogen-flushed headspace. Alu-Alu blister or HDPE bottle with desiccant.
HS code21069099
Prenatal DHA softgels are the oil half of a prenatal programme — the part that cannot be compressed into a multivitamin tablet — and Thovek makes them to the buyer's brief in two distinct builds. The marine build fills refined, deodorised fish body oil or an omega-3 concentrate from Engraulis ringens, Sardinops sagax and Scomber spp.; the vegetarian build fills fermentation-grown Schizochytrium sp. microalgal oil, which involves no ocean harvest and carries no fish allergen. Either way the active is docosahexaenoic acid, CAS 6217-54-5, C22H32O2, 328.5 g/mol, formally (4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenoic acid. Folate travels in the same fill, suspended in the oil, as folic acid (CAS 59-30-3, C19H19N7O6, 441.4 g/mol) or as levomefolate calcium (CAS 151533-22-1, C20H23CaN7O6, 497.5 g/mol) where the destination market prefers the reduced, methylated salt. The dose base most buyers start from is 200 mg of DHA per day: the condition of use attached to maternal DHA labelling in the EU register is 200 mg of DHA in addition to the 250 mg of DHA plus EPA recommended for adults, so a 500 mg or 1000 mg fill is sized to deliver that from the chosen oil's assay. Folate is usually set at 400–800 µg, against an EU nutrient reference value of 200 µg (Reg. (EU) No 1169/2011, Annex XIII) and an EFSA tolerable upper intake level of 1000 µg per day for adults and in pregnancy — a ceiling that counts added folic acid and the 5-methyltetrahydrofolate salts but not folate naturally present in food. EFSA has derived no upper level for DHA, EPA or DPA. These are formulation and labelling reference points for the buyer's regulatory team. Thovek makes no therapeutic or disease representation and the finished label is the buyer's responsibility. The allergen line is where the two builds part company commercially. The marine build contains FISH and must be declared as such in the EU: Annex II of Reg. (EU) No 1169/2011 exempts only fish gelatine used as a carrier for vitamin or carotenoid preparations, not fish oil, however highly refined. US FALCPA treats highly refined oils differently, which is why one artwork rarely serves both markets. The algal build is fish-free and, in a starch and glycerin shell, vegan; a bovine or fish gelatine shell removes that status and must be stated on the specification. Oils are stabilised with mixed tocopherols and held to the GOED voluntary monograph — peroxide value not more than 5 meq/kg, p-anisidine not more than 20, TOTOX not more than 26 — and marine builds are tested against the Reg. (EU) 2023/915 limits for dioxins, dioxin-like PCBs and ICES-6 non-dioxin-like PCBs. Release testing covers DHA by GC, folate by HPLC, fill weight, seal integrity, heavy metals and microbiology, and each shipment carries the batch certificate of analysis, allergen, GMO and diet declarations, stability data and halal or kosher certificates where the shell material allows.

Applications

Private-label prenatal rangesMaternal nutrition programmesCompanion pack to prenatal tabletsVegetarian and vegan prenatal formatsPharmacy own-label softgelsContract manufacturing programmesClinic-dispensed maternal rangesE-commerce supplement brands

Available grades

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.

Packaging: Alu-Alu blisters of 10 or 15 softgels in printed cartons with leaflet, or 30 / 60 / 90-count HDPE bottles with induction seal and silica gel desiccant; Alu-Alu is recommended for humid destinations because the folate load is moisture sensitive. Bulk softgels for downstream packing are supplied 10–25 kg net in food-grade double LDPE liners inside fibre or HDPE drums, nitrogen flushed with desiccant. Palletised and shrink-wrapped for FCL or LCL export; ship and store cool, dark and dry.

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