Betaine HCl + Pepsin Capsules

Betaine HCl + Pepsin Capsules

Betaine hydrochloride with porcine pepsin (EC 3.4.23.1) · two-component acid-and-protease capsule

Capsules pairing assayed betaine hydrochloride with NF-grade porcine pepsin. Two actives specified separately, porcine origin declared, private label and contract manufacture from India.

Specifications

CompositionTwo declared actives - betaine hydrochloride as the acid component and pepsin as the protease component; the ratio and per-capsule strengths are fixed by the approved formula
Betaine HCl identityBetaine hydrochloride, CAS 590-46-5, EINECS 209-683-1, C5H12ClNO2, MW 153.61; IUPAC carboxymethyl(trimethyl)azanium chloride; PubChem CID 11545
Free-base conversionBetaine (trimethylglycine) CAS 107-43-7, C5H11NO2, MW 117.15 - the free base is 76.3% of the hydrochloride by mass, the factor to use when a label declares betaine
Betaine originBetaine occurs naturally in sugar beet (Beta vulgaris), the source of its name; supplied as beet-derived or synthetic material with the origin stated on the certificate of analysis
Pepsin identityPepsin, EC 3.4.23.1, CAS 9001-75-6; an aspartic protease secreted in vivo as the zymogen pepsinogen
Pepsin sourceExtracted from the glandular layer of hog stomachs - porcine material. Not vegetarian, not vegan, not halal and not kosher under any capsule shell option
Pepsin potencyNF trade designations 1:3,000 and 1:10,000; the ratio is the multiple of its own weight of coagulated protein substrate digested under the NF assay. Grade fixed in the spec
pH activity windowPepsin is most active between pH 1.5 and 2.5 and is not fully denatured until pH 8.0; betaine hydrochloride is the acidifying component of the pair
Capsule shellBovine gelatin or vegetarian HPMC, size 0 or 00 typical. Note the fill is porcine, so an HPMC shell does not make the finished product vegetarian
Allergen statusNo milk, egg, fish, crustacean, soy, peanut, tree nut or gluten input. Porcine origin must be declared on label, specification and customer allergen questionnaire
Regulatory noteUS FDA ended OTC marketing of betaine hydrochloride as a gastric aid drug in 1993; it continues in trade as a supplement ingredient - confirm status per destination market
HandlingBoth actives are moisture-sensitive, so blending, encapsulation and packing run under controlled low humidity with band sealing or alu-alu blistering as the moisture barrier
TestingBetaine HCl assay by titration or HPLC, pepsin activity by the NF proteolytic assay, fill weight variation, disintegration, heavy metals and microbiology
Storage and shelf lifeBelow 25 °C at RH not above 60%, away from light; 24 months from manufacture in the unopened alu-alu blister or desiccated HDPE bottle, with stability data on request
HS code21069099 as finished capsules; bulk betaine hydrochloride alone 29239000, bulk pepsin alone 35079099
This is a two-component capsule rather than a single active, and the two components come from very different places. Betaine hydrochloride (CAS 590-46-5, EINECS 209-683-1, C5H12ClNO2, molecular weight 153.61, IUPAC carboxymethyl(trimethyl)azanium chloride, PubChem CID 11545) is the acid salt of betaine - the trimethylglycine first identified in sugar beet, Beta vulgaris, and named after it. The free base (CAS 107-43-7, C5H11NO2, molecular weight 117.15) accounts for 76.3% of the salt by mass, which is the conversion a formulator needs whenever a label declares betaine rather than betaine HCl. Pepsin (EC 3.4.23.1, CAS 9001-75-6) is the aspartic protease of the stomach, secreted in vivo as the zymogen pepsinogen and recovered commercially from the glandular layer of hog stomachs. Pepsin is most active between pH 1.5 and 2.5 and is not fully denatured until pH 8.0, so the pairing is straightforward formulation logic: the hydrochloride is the acid component and the protease is the enzyme component, and each is specified on its own terms rather than as a single blended potency. Pepsin is bought on NF potency designation, with 1:3,000 and 1:10,000 the standard trade grades - the ratio expressing the multiple of its own weight of coagulated protein substrate that the pepsin digests under the NF assay - while betaine hydrochloride is bought on assay. Both are moisture-sensitive, so blending and encapsulation run under controlled low humidity and the preferred pack is alu-alu blister or a desiccated, induction-sealed bottle. The origin declaration on this product is the commercially load-bearing one and buyers should read it before anything else. Pepsin is porcine. An HPMC capsule shell does not make the product vegetarian, and no build of it can be vegan, halal or kosher; ranges with those requirements need a plant- or microbial-protease formulation instead, which Thovek quotes separately. Beyond that the allergen picture is clean, with no milk, egg, fish, crustacean, soy, peanut, tree nut or gluten input. One regulatory point belongs in every market file: the US FDA ended over-the-counter marketing of betaine hydrochloride as a gastric aid drug in 1993, and the ingredient continues in trade as a dietary supplement component, so permitted status, permitted level and permitted label wording must be confirmed for each destination before artwork is signed off.

Applications

Private-label digestive capsulesContract capsule manufacturingMulti-enzyme blend componentProtein-focused digestive SKUsPractitioner-channel supplement rangesPharmacy own-label linesE-commerce supplement brandsNon-vegetarian formula ranges

Available grades

Health-supplement grade; betaine hydrochloride to an agreed assay specification, pepsin to NF potency designation (1:3,000 or 1:10,000); FSSAI-licensed GMP manufacture with HACCP and ISO 22000; gluten-free. Porcine - not vegetarian, vegan, halal or kosher

Packaging: Alu-alu blisters of 10, 15 or 30 capsules in printed mono-cartons with leaflet, or 30/60/90/120/180-count HDPE bottles with induction seal, silica-gel or molecular-sieve desiccant canister and optional child-resistant cap; alu-alu is strongly preferred here because both the acid salt and the enzyme lose specification on moisture pickup. Unpacked bulk capsules ship in double food-grade LDPE liners inside 20-25 kg fibre drums. Cartons and bottles are shrink-wrapped into 5-ply export corrugated shippers, strapped and palletised on ISPM-15 heat-treated pallets, batch-coded at every packaging level.

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